{"_guid_type":"discovery_metadata","nih_reporter":{"terms":"<Action Potentials><Adoption><Biometrics><Biostatistics><Biometry><Clinical Study><Clinical Research><Data Collection><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><Double-Blind Method><Elements><Feasibility Studies><Hyperalgesic Sensations><hyperalgia><Hyperalgesia><biomedical implant><implant device><indwelling device><implantable device><Incidence><Length of Life><life span><lifespan><Longevity><Neurons><Nerve Cells><Nerve Unit><Neural Cell><Neurocyte><neuronal><Pain><Painful><Pain Measurement><Analgesia Tests><Nociception Tests><Pain Assessment><Pain measure><pain assay><Paresthesia><Patients><Research><Risk><Rodent><Rodentia><Rodents Mammals><Role><social role><Esthesia><Sensation><Computer software><Software><Software Design><Designing computer software><Software Validation><Software Verification><Technology><Testing><Time><measurable outcome><outcome measurement><Outcome Measure><chronic pain><therapy failure><Treatment Failure><improved><Acute><Clinical><Refractory><Phase><Variation><Variant><Physiologic><Physiological><Medical><Evaluation><Training><Fiber><disability><Stimulus><Recovery><Opiates><Opioid><Measurement><randomized control trial><Randomized, Controlled Trials><Morphology><Nature><Pulse><Physiologic pulse><Spinal Cord Stimulation><Neurostimulation procedures of spinal cord tissue><Investigation><Frequencies><Sensory><Pattern><Location><allodynia><posterior column><dorsal column><Width><novel><Modality><Devices><Reporting><response><Effectiveness><Data><Randomized><randomisation><randomization><randomly assigned><research clinical testing><Clinical Evaluation><Clinical Testing><clinical test><Longterm Follow-up><Long-term Follow-up><long-term followup><longterm followup><Numeric Rating Scale><Numerical Scale><Development><developmental><pre-clinical><preclinical><preclinical study><pre-clinical study><time use><design><designing><Treatment Efficacy><intervention efficacy><therapeutic efficacy><therapy efficacy><Clinical effectiveness><Outcome><human study><innovation><innovate><innovative><treatment effect><Implant><implantation><Systems Development><Institutional Review Boards><IRB><IRBs><behavioral response><behavior response><habituation><treatment responders><therapy responders><improved outcome><opioid use><opiate consumption><opiate drug use><opiate intake><opiate use><opioid consumption><opioid drug use><opioid intake><recruit><pain outcome><pain-related outcome><pain model><pain reduction><reduce pain><pain patient><chronic pain patient><patient with chronic pain><pain relief><relieve pain><clinical pain><Nonpharmacologic Therapy><Non-pharmacologic Therapy><first-in-human><first in man><opioid misuse><non-medical opioid use><nonmedical opioid use><opiate misuse><randomized controlled design><chronic pain management><chronic pain control><chronic pain intervention><chronic pain therapy><chronic pain treatment><treat chronic pain><Home><homes><porcine model><pig model><piglet model><swine model><digital data>","is_new":false,"appl_id":10732537,"phr_text":"Project Narrative. Spinal cord stimulation (SCS) is a promising nonpharmacological intervention for the treatment of chronic pain.. Current technology for SCS is based on time-invariant pulses (TIP) which can constrain the location and. quality of paresthesia coverage, and contribute to the development of tolerance to the therapy. To overcome. these challenges, we propose to develop and clinically test a device capable of delivering novel stimulation. time variant pulse (TVPs) patterns, in which a stimulation parameter changes according to a modulatory time-. varying function, a strategy which may lead to improved long-term pain outcomes with SCS.","cfda_code":"853","cong_dist":"TX-09","is_active":true,"award_type":"4N","budget_end":"2025-02-28T12:02:00Z","date_added":"2024-03-09T04:03:47Z","pref_terms":"Action Potentials;Acute;Adoption;Biometry;Clinical;Clinical Research;Clinical effectiveness;Computer software;Data;Data Collection;Development;Devices;Double-Blind Method;Effectiveness;Elements;Esthesia;Evaluation;Feasibility Studies;Fiber;Frequencies;Home;Hyperalgesia;Implant;Incidence;Institutional Review Boards;Investigation;Location;Longevity;Longterm Follow-up;Measurement;Medical;Modality;Morphology;Nature;Neurons;Neurostimulation procedures of spinal cord tissue;Nonpharmacologic Therapy;Numeric Rating Scale;Opioid;Outcome;Outcome Measure;Pain;Pain Measurement;Paresthesia;Patients;Pattern;Phase;Physiologic pulse;Physiological;Randomized;Randomized, Controlled Trials;Recovery;Refractory;Reporting;Research;Risk;Rodent;Role;Sensory;Software Design;Software Validation;Stimulus;Systems Development;Technology;Testing;Time;Training;Treatment Efficacy;Treatment Failure;Variant;Width;allodynia;behavioral response;chronic pain;chronic pain management;chronic pain patient;clinical pain;design;digital data;disability;dorsal column;first-in-human;habituation;human study;implantable device;implantation;improved;improved outcome;innovation;novel;opioid misuse;opioid use;pain model;pain outcome;pain patient;pain reduction;pain relief;porcine model;pre-clinical;preclinical study;randomized controlled design;recruit;research clinical testing;response;time use;treatment effect;treatment responders","agency_code":"NIH","arra_funded":"N","fiscal_year":2024,"project_num":"4UH3NS121563-02","award_amount":1849426,"budget_start":"2024-03-01T12:03:00Z","organization":{"city":null,"country":null,"org_city":"HOUSTON","org_duns":["051113330"],"org_fips":"US","org_name":"BAYLOR COLLEGE OF MEDICINE","org_ueis":["FXKMA43NTV21"],"dept_type":"NEUROSURGERY","org_state":"TX","org_country":"UNITED STATES","org_zipcode":"770303411","primary_uei":"FXKMA43NTV21","org_ipf_code":"481201","primary_duns":"051113330","org_state_name":null,"external_org_id":481201,"fips_country_code":null},"abstract_text":"Project Summary. Spinal cord stimulation (SCS) is a nonpharmacological intervention for the treatment of chronic pain. Importantly,. SCS may be more effective than opioids for pain relief and has been demonstrated to reduce opioid misuse in. pain patients. Current SCS therapy uses time-invariant pulses (TIP), which is based on stimulation with fixed. parameter pulse trains. However, SCS based on TIP stimulation has two critical challenges: 1) limited ability to. contour the location and quality of the paresthesia coverage and 2) loss of treatment effect due to tolerance.. To overcome these challenges, we propose the use of novel stimulation time variant pulse (TVPs) patterns, in. which a stimulation parameter changes according to a modulatory time-varying function. TVPs may provide. better therapy than TIPs in two ways. First, TVPs can change the recruitment of dorsal column fibers on a pulse. by pulse basis in a way impossible via TIPs. Support for this comes from our pilot pre-clinical study in which we. demonstrated that TVPs can generate dorsal column evoked compound action potentials (ECAPs) whose. morphologies vary with the applied TVPs. Second, the time-varying nature of TVPs may produce better sensory. encoding compared to TIPs. Support for this comes from preliminary results from our own and an independent. pilot, acute clinical study suggesting that TVPs can produce dynamic, enhanced coverage of the painful region. and improved perceived sensations in chronic pain patients.. Our central hypotheses is that TVPs can improve outcomes for SCS by enhancing paresthesia coverage and. reducing tolerance by varying spatial neuronal recruitment. In this proposal, we will develop devices capable of. delivering TVPs and perform long-term clinical testing in chronic pain patients to define the role of TVP SCS in. the management of intractable chronic pain. In this study, we will develop the firmware and software to deliver. TVPs, and obtain IRB and IDE approval for a clinical study using an implantable pulse generator capable of. delivering TVPs (Aim 1/UG3). Then, we will conduct a First in Human feasibility study with a double-blind,. randomized-controlled design (Aim 2/UH3), to determine the extent to which SCS TVP can reduce pain and. disability.","activity_code":"UH3","project_title":"Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation","subproject_id":null,"covid_response":null,"agency_ic_admin":{"code":"NS","name":"National Institute of Neurological Disorders and Stroke","abbreviation":"NINDS"},"contact_pi_name":"VISWANATHAN, ASHWIN","direct_cost_amt":1486400,"core_project_num":"UH3NS121563","program_officers":[{"full_name":"ERIC MICHAEL Hudak","last_name":"Hudak","first_name":"ERIC","middle_name":"MICHAEL"}],"project_end_date":"2028-02-29T12:02:00Z","award_notice_date":"2024-03-06T12:03:00Z","funding_mechanism":"Non-SBIR/STTR","indirect_cost_amt":363026,"mechanism_code_dc":"RP","organization_type":{"code":"10","name":"SCHOOLS OF MEDICINE","is_other":false},"project_num_split":{"ic_code":"NS","serial_num":"121563","suffix_code":"","support_year":"02","activity_code":"UH3","appl_type_code":"4","full_support_year":"02"},"agency_ic_fundings":[{"fy":2024,"code":"NS","name":"National Institute of Neurological Disorders and Stroke","total_cost":1849426,"abbreviation":"NINDS"}],"full_study_section":{"name":"Neurological Sciences and Disorders C Study Section[NSD-C]","srg_code":"NSD","srg_flex":"","group_code":"","sra_flex_code":"","sra_designator_code":""},"opportunity_number":"RFA-NS-18-011","project_detail_url":"https://reporter.nih.gov/project-details/10732537","project_serial_num":"NS121563","project_start_date":"2022-04-07T12:04:00Z","spending_categories":null,"principal_investigators":[{"title":"","full_name":"Rosana  Esteller","last_name":"Esteller","first_name":"Rosana","profile_id":15997690,"middle_name":"","is_contact_pi":false},{"title":"ASSISTANT PROFESSOR","full_name":"Ashwin  Viswanathan","last_name":"Viswanathan","first_name":"Ashwin","profile_id":11861255,"middle_name":"","is_contact_pi":true}],"spending_categories_desc":null},"gen3_discovery":{"tags":[{"name":"4891 Pain Catastrophizing Scale - Parent (PCS-P)","category":"Common Data Elements"},{"name":"5016 Patient Global Impression of Change (PGIC)","category":"Common Data Elements"},{"name":"5086 Brief Pain Inventory (BPI)","category":"Common Data Elements"},{"name":"5351 Generalized Anxiety Disorder (GAD-7)","category":"Common Data Elements"},{"name":"5376 Patient Health Questionnaire (PHQ-9)","category":"Common Data Elements"},{"name":"SPARC","category":"Data Repository"},{"name":"Clinical Research","category":"Study Type"},{"name":"Questionnaire/Survey/Assessment","category":"Data Type"},{"name":"Human","category":"Subject Type"},{"name":"Adult (19 to 44 years)","category":"Age"},{"name":"Middle aged adult (45 to 64 years)","category":"Age"},{"name":"Aged adult (65 to 79 years)","category":"Age"},{"name":"Aged, 80 and over (80 years and over)","category":"Age"}],"authz":"","_hdp_uid":"HDP01327","__manifest":[],"institutions":"BAYLOR COLLEGE OF MEDICINE","year_awarded":2024,"is_registered":true,"project_number":"4UH3NS121563-02","study_metadata":{"data":{"data_type":["Questionnaire/Survey/Assessment - validated instrument","Questionnaire/Survey/Assessment"],"data_source":["Patient-Reported","Researcher Collected/Measured"],"data_orientation":["Quantitative"],"subject_data_level_available":["Aggregated, by treatment/exposure group","Individual - Aggregated"],"subject_data_unit_of_analysis":["Individual"],"subject_data_unit_of_collection":["Individual"],"subject_geographic_data_level_available":["Zip code","County","State"],"subject_geographic_data_level_collected":["Zip code","State","County"],"subject_data_unit_of_analysis_expected_number":"43","subject_data_unit_of_collection_expected_number":"43"},"citation":{"funding":[],"investigators":[{"investigator_last_name":"Esteller","investigator_first_name":"Rosana","investigator_middle_initial":""},{"investigator_last_name":"Viswanathan","investigator_first_name":"Ashwin","investigator_middle_initial":""}],"study_collections":[],"heal_funded_status":"","heal_platform_citation":"","study_collection_status":"","heal_platform_persistent_ID":""},"findings":{"primary_publications":[],"primary_study_findings":[],"secondary_publications":[]},"study_type":{"study_stage":["Clinical Research"],"study_type_design":["Cross-over","Randomized Control Trial"],"study_subject_type":["Human"],"study_primary_or_secondary":"Primary Research","study_observational_or_experimental":"Experimental Research"},"minimal_info":{"study_name":"Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation","study_description":"Project Summary. Spinal cord stimulation (SCS) is a nonpharmacological intervention for the treatment of chronic pain. Importantly,. SCS may be more effective than opioids for pain relief and has been demonstrated to reduce opioid misuse in. pain patients. Current SCS therapy uses time-invariant pulses (TIP), which is based on stimulation with fixed. parameter pulse trains. However, SCS based on TIP stimulation has two critical challenges: 1) limited ability to. contour the location and quality of the paresthesia coverage and 2) loss of treatment effect due to tolerance.. To overcome these challenges, we propose the use of novel stimulation time variant pulse (TVPs) patterns, in. which a stimulation parameter changes according to a modulatory time-varying function. TVPs may provide. better therapy than TIPs in two ways. First, TVPs can change the recruitment of dorsal column fibers on a pulse. by pulse basis in a way impossible via TIPs. Support for this comes from our pilot pre-clinical study in which we. demonstrated that TVPs can generate dorsal column evoked compound action potentials (ECAPs) whose. morphologies vary with the applied TVPs. Second, the time-varying nature of TVPs may produce better sensory. encoding compared to TIPs. Support for this comes from preliminary results from our own and an independent. pilot, acute clinical study suggesting that TVPs can produce dynamic, enhanced coverage of the painful region. and improved perceived sensations in chronic pain patients.. Our central hypotheses is that TVPs can improve outcomes for SCS by enhancing paresthesia coverage and. reducing tolerance by varying spatial neuronal recruitment. In this proposal, we will develop devices capable of. delivering TVPs and perform long-term clinical testing in chronic pain patients to define the role of TVP SCS in. the management of intractable chronic pain. In this study, we will develop the firmware and software to deliver. TVPs, and obtain IRB and IDE approval for a clinical study using an implantable pulse generator capable of. delivering TVPs (Aim 1/UG3). Then, we will conduct a First in Human feasibility study with a double-blind,. randomized-controlled design (Aim 2/UH3), to determine the extent to which SCS TVP can reduce pain and. disability.","alternative_study_name":"Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation","alternative_study_description":"The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection."},"data_availability":{"produce_data":"Yes","produce_other":"No","data_available":"some","data_restricted":"none","data_release_status":"not started","data_collection_status":"started","data_release_start_date":"2027-12-31","data_release_finish_date":"2028-06-30","data_collection_start_date":"2024-06-01","data_collection_finish_date":"2028-01"},"metadata_location":{"data_repositories":[{"repository_name":"SPARC","repository_citation":"Users must also include a citation to the data as specified by the local repository.","repository_study_ID":"","repository_study_link":"","repository_persistent_ID":""}],"nih_reporter_link":"https://reporter.nih.gov/project-details/10732537","nih_application_id":10732537,"other_study_websites":[],"clinical_trials_study_ID":"NCT05968664","cedar_study_level_metadata_template_instance_ID":"https://repo.metadatacenter.org/template-instances/75918d58-5ca4-45e4-a0d9-17f61166a30e"},"documentation_link":{},"contacts_and_registrants":{"contacts":[],"registrants":[]},"study_translational_focus":{"study_translational_focus":"Treatment of a Condition","study_translational_topic_grouping":["Biology and Health"]},"human_subject_applicability":{"age_applicability":["Adult (19 to 44 years)","Middle aged adult (45 to 64 years)","Aged adult (65 to 79 years)","Aged, 80 and over (80 years and over)"],"gender_applicability":[],"geographic_applicability":["TX"],"biological_sex_applicability":["Male","Female"],"sexual_identity_applicability":[],"irb_vulnerability_conditions_applicability":[]},"human_condition_applicability":{"condition_category":["Pain, chronic"],"all_other_condition":[],"all_outcome_condition":[],"pain_causal_condition":[],"condition_investigation_stage_or_type":["Treatment of condition"],"all_treatment_or_study_target_condition":[],"pain_treatment_or_study_target_condition":["Pain, chronic"]},"human_treatment_applicability":{"treatment_mode":["Therapeutic (treating an occurrence)"],"treatment_type":["device"],"treatment_novelty":["Novel"],"treatment_application_level":["Individual"],"treatment_investigation_stage_or_type":["treatment efficacy","treatment mechanism"]}},"related_studies":[],"administering_ic":"National Institute of Neurological Disorders and Stroke","advSearchFilters":[{"key":"Common Data Elements","value":"4891 Pain Catastrophizing Scale - Parent (PCS-P)"},{"key":"Common Data Elements","value":"5016 Patient Global Impression of Change (PGIC)"},{"key":"Common Data Elements","value":"5086 Brief Pain Inventory (BPI)"},{"key":"Study Type","value":"Clinical Research"},{"key":"Data Type","value":"Questionnaire/Survey/Assessment"},{"key":"Subject Type","value":"Human"},{"key":"Age","value":"Adult (19 to 44 years)"},{"key":"Age","value":"Middle aged adult (45 to 64 years)"},{"key":"Age","value":"Aged adult (65 to 79 years)"},{"key":"Age","value":"Aged, 80 and over (80 years and over)"}],"research_program":"","variable_metadata":{"drupal_ids":["5351","5016","5086","5376","4891"],"field_names":["BPIAvgPainRatingScl","PCSPNeverGetBetterScale","PCSPCantGoOnScale","PCSPOverwhelmScale","PHQFlngFailrScore","GAD7RstlessScl","PCSPNothingCanDoScale","PHQTotalScore","PCSPOthrPainEventScale","PCSPPainGoAwayScale","PGICSymptomChangeStatVal","BPIWorstPainRatingScl","PHQBttrDdThghtScore","PHQDiffcltyPerfScl","PCSPHelplessnessSubScl","PHQAbnrmlDietScore","BPILeastPainRatingScl","GAD2FeelNervScl","PHQConcntrtnImprmntScore","PCSPCantStandPainScale","GAD7TroubRelxScl","PHQSleepImpairScore","PCSPWorryPainEndScale","PCSPMagnificationSubScl","GAD7WryTooMchScl","PHQMovmntSpchImprmntScore","PCSPPainWorsenScale","GAD7FeelAfrdScl","PCSPRuminationSubScl","PCSPWantPainStopScale","PHQDeprssnScore","PCSPTotalScore","GAD2NotStopWryScl","PCSPPainOutOfMindScale","PHQTirdLittleEnrgyScore","PCSPSeriousHappenScale","PCSPSufferingScale","GAD7EasyAnnoyedScl","BPICurrentPainRatingScl","PHQLitIntrstScore","GAD7TotScore"],"field_titles":[],"field_descriptions":["Score of how much the subject has been suffering with moving or speaking too slowly in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Scale describing how much the participant/subject keeps thinking about other painful events when their child has pain; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Scale indicating the rating of the least pain experienced by the subject, as part of the Brief Pain Inventory (BPI) form.","Total score for the GAD-7 used for office coding, as a part of Generalized Anxiety Disorder (GAD-7).","Score of how much the subject  has been bothered by abnormal diet/appetite in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Computed Rumination subscale score for thePain Catastrophizing Scale - Parent (PCS-P) ","Scale describing how much the participant/subject feels their child's pain is terrible and will never get better; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Scale describing how much the participant/subject feels that when their child is in pain there is nothing the parent can do to reduce the pain; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Computed overall score for the Pain Catastrophizing Scale - Parent (PCS-P) , calculated as the sum of responses to all items. ","Status describing the change in the subject's symptoms have since the beginning of treatment as a part of the Patient Global Impression of Change","Scale describing how often participant/subject feels afraid as if something awful might happen, as a part of Generalized Anxiety Disorder (GAD-7).","Scale rating the pain the subject is feeling right now, as part of the Brief Pain Inventory (BPI) form.","Scale describing how much the participant/subject feels that their child's pain is awful and this takes over (overwhelms) the parent; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Scale describing how often participant/subject has not been able to stop or control worrying, as a part of Generalized Anxiety Disorder (GAD-7).","Scale describing how often participant/subject is so restless that it is hard to sit still, as a part of Generalized Anxiety Disorder (GAD-7).","Scale describing how much the participant/subject keeps thinking about how much they want their child's pain to stop; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Score of how much the subject has been bothered by having little interest or pleasure in doing things in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Scale indicating the rating of the worst pain, as part of the Brief Pain Inventory (BPI) form.","Computed Magnification subscale score for the Pain Catastrophizing Scale - Parent (PCS-P) ","Scale describing how much the participant/subject worries whether something serious may happen when their child is in pain; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Scale indicating the rating of the average pain experienced by the subject, as part of the Brief Pain Inventory (BPI) form.","Scale describing how much the participant/subject feels they cannot go on when their child has pain; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Scale describing how much the participant/subject fears that their child's pain will get worse; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Score of how much the subject has been bothered with troubling concentrating in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Score of how much the subject has been feeling down and depressed in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Computed Helplessness subscale score for the Pain Catastrophizing Scale - Parent (PCS-P) ","Scale describing how much the participant/subject worries all the time about whether the child's pain will end; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Score of how much the subject has been feeling bad for himself/herself in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Scale describing how much the participant/subject keeps thinking about how much their child is suffering when they have pain; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Score of how much the subject has been bothered with troubling falling/staying asleep or sleeping too much in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Score of how much the subject has been feeling tired in the past two weeks, as part of the Patient Health Questionnaire (PHQ).","Scale describing how much the participant/subject feels they cannot keep their child's pain out of their mind; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Score of how much the subject has been suffering with the thoughts of that he/she would be better off dead to hurt, as part of the Patient Health Questionnaire (PHQ).","Scale describing how often participant/subject has been bothered by feeling nervous, anxious or on edge, as a part of Generalized Anxiety Disorder (GAD-7). ","Scale describing how often participant/subject has trouble relaxing, as a part of Generalized Anxiety Disorder (GAD-7).","Scale describing how much the participant/subject feels that they can no longer stand their child's pain; part of the Pain Catastrophizing Scale - Parent (PCS-C)","The scale related to how difficult it is to do work, take care of things at home, or get along with other people for the subject, as part of the Patient Health Questionnaire (PHQ).","Scale describing how much the participant/subject feels they want their child's pain to go away; part of the Pain Catastrophizing Scale - Parent (PCS-C)","Scale describing how often participant/subject becomes easily annoyed or irritable, as a part of Generalized Anxiety Disorder (GAD-7).","Scale describing how often participant/subject worries too much about different things, as a part of Generalized Anxiety Disorder (GAD-7).","Total score of the questionnaire, as the part of Patient Health Questionnaire Depression (PHQ)."],"field_standards_mappings_ids":["C103707","C103568","C103714","C103708","C103570","C103571","C113887","C135818","C103711","C103566","C103569","C100362","C113886","C103713","C103710","C103565","C103567","C103706","C103712","C100359","C103705","C100360","C100361","C103709"],"field_standards_mappings_sources":["CDISC"],"standards_mappings_instrument_ids":["5351","5016","5086","5376","4891"],"standards_mappings_instrument_titles":["Patient Global Impression of Change (PGIC)","Patient Health Questionnaire (PHQ-9)","Generalized Anxiety Disorder (GAD-7)","Pain Catastrophizing Scale - Parent (PCS-P)","Brief Pain Inventory (BPI)"],"field_standards_mappings_id_source_combos":["CDISC C103571","CDISC C100360","CDISC C135818","CDISC C103569","CDISC C103706","CDISC C103568","CDISC C103565","CDISC C103711","CDISC C103709","CDISC C100359","CDISC C113886","CDISC C100362","CDISC C113887","CDISC C103713","CDISC C103566","CDISC C103705","CDISC C103570","CDISC C103567","CDISC C103707","CDISC C103708","CDISC C103710","CDISC C103714","CDISC C100361","CDISC C103712"]},"investigators_name":["Rosana  Esteller","Ashwin  Viswanathan"],"registration_authz":"/study/10732537","registrant_username":"0009-0009-4282-5215","research_focus_area":"","time_of_registration":"2024-07-30T07:28:09-07:00","time_of_last_cedar_updated":"2026-02-19T12:36:20-08:00"},"clinicaltrials_gov":{"protocolSection":{"designModule":{"phases":["NA"],"studyType":"INTERVENTIONAL","designInfo":{"allocation":"RANDOMIZED","primaryPurpose":"TREATMENT","interventionModel":"CROSSOVER"},"enrollmentInfo":{"type":"ESTIMATED","count":43}},"statusModule":{"overallStatus":"RECRUITING","startDateStruct":{"date":"2024-08-01","type":"ACTUAL"},"completionDateStruct":{"date":"2028-01","type":"ESTIMATED"}},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Patient responder rate"}]},"oversightModule":{"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":true},"conditionsModule":{"conditions":["Chronic Pain","Pain, Neuropathic","Neuropathic Pain"]},"descriptionModule":{"briefSummary":"The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.","detailedDescription":"The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection."},"eligibilityModule":{"sex":"ALL","minimumAge":"22 Years"},"identificationModule":{"nctId":"NCT05968664","acronym":"DYNAMO","briefTitle":"Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation","officialTitle":"Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation"},"armsInterventionsModule":{"interventions":[{"type":"DEVICE"},{"type":"DEVICE"}]},"ipdSharingStatementModule":{"ipdSharing":"YES"}}},"variable_level_metadata":{"common_data_elements":{"5086 Brief Pain Inventory (BPI)":"HDPCDE5086","5351 Generalized Anxiety Disorder (GAD-7)":"HDPCDE5351","5376 Patient Health Questionnaire (PHQ-9)":"HDPCDE5376","5016 Patient Global Impression of Change (PGIC)":"HDPCDE5016","4891 Pain Catastrophizing Scale - Parent (PCS-P)":"HDPCDE4891"}}}