Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:50 PM
Study NCT ID:
NCT07481292
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-20
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'C535728', 'term': 'Dysautonomia like disorder'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of enrollees who are eligible to participate', 'timeFrame': 'From enrollment to baseline PASS submission (up to 48-hours)', 'description': "The number of enrollees (i.e., participants who consent) who score ≥20 on the baseline Pediatric Autonomic Symptom Scales (PASS), divided by the total number of enrollees. This assesses 'Eligibility'."}, {'measure': 'Proportion of participants complying with instructions', 'timeFrame': 'From enrollment to the end of participation (up to 12 weeks)', 'description': "The number of participants submitting online surveys within the 48-hour submission window, divided by the total number of participants. This assesses 'Compliance'"}, {'measure': 'Proportion of participants adhering to the care plan', 'timeFrame': 'From enrollment to the end of participation (up to 12 weeks)', 'description': "The number of participants attending ≥90% of scheduled remote sessions with their CIH practitioner, divided by the total number of participants. This assesses 'Adherence'"}, {'measure': 'Proportion of participants retained in the study', 'timeFrame': 'From enrollment to the end of the 12 week study period', 'description': "The number of participants submitting the 4th and final online surveys, divided by the total number of participants. This assesses 'Retention'."}], 'secondaryOutcomes': [{'measure': 'Change in Pediatric Autonomic Symptom Scales (PASS) scores', 'timeFrame': 'Baseline; ~4 weeks; ~8 weeks; ~12 weeks', 'description': 'Change in PASS scores from baseline. The PASS is validated 80-item parent-report questionnaire designed to assess autonomic function in children across four main subscales: 1) mood, behavior, and emotion; 2) secretomotor/sensory integration; 3) urinary/gastrointestinal systems; 4) circulation, thermoregulation, sleep, and breathing. PASS total scores can range from 0 (no autonomic symptoms) to 80 (severe dysautonomia).'}, {'measure': 'Change in Short Sensory Profile (SSP) scores', 'timeFrame': 'Baseline; ~4 weeks; ~8 weeks; ~12 weeks', 'description': "Change in SSP scores from baseline. The SSP is a validated 38-item parent-report designed to assess a child's responsiveness to sensory stimuli including tactile sensitivity, taste/smell sensitivity, and visual/auditory sensitivity. SSP total scores can range from 38 (extreme sensitivity) to 190 (no sensitivity)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dysautonomia', 'Pilot Projects', 'Pediatrics', 'Complementary Therapies'], 'conditions': ['Dysautonomia', 'Dysautonomia Like Disorder']}, 'descriptionModule': {'briefSummary': 'To investigate the feasibility of implementing an online assessment battery in tandem with normal \\& customary complementary \\& integrative healthcare (CIH) provided to children with dysautonomia. The secondary aim is to assess the potential impacts of CIH on clinical outcomes.', 'detailedDescription': 'The main aim of this pilot observational study is to investigate the feasibility of implementing an online assessment battery in tandem with normal \\& customary, fee-for-service, remotely delivered complementary \\& integrative healthcare (CIH, i.e., Neuro-Emotional Release: Veins \\& Endocrine System \\[NERVE\\] therapy) provided to children with significant parent-reported symptoms of dysautonomia. The primary outcomes are 1) eligibility, 2) compliance, 3) adherence, and 4) retention. A secondary/exploratory aim is to assess the potential clinical impacts of CIH via a validated parent-reported outcome measure (i.e., Pediatric Autonomic Symptom Scales, PASS; Short Sensory Profile, SSP). Data from this study will inform the feasibility of a definitive study powered to assess the effectiveness of NERVE therapy on clinical outcomes in a pediatric population with symptoms of dysautonomia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 5-14 years whose parents/caregivers identify the presence of symptoms associated with dysautonomia. A formal clinical diagnosis is not required for inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 5-14 years of age\n* Baseline PASS score ≥20\n\nExclusion Criteria:\n\n* History of epilepsy'}, 'identificationModule': {'nctId': 'NCT07481292', 'acronym': 'PAK', 'briefTitle': 'Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia', 'organization': {'class': 'OTHER', 'fullName': 'Life University'}, 'officialTitle': 'Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia: a Pilot Observational Study', 'orgStudyIdInfo': {'id': 'EXPTP031326'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children (5-12) with Dysautonomia', 'description': 'Children aged 5-14 years whose parents/caregivers identify the presence of symptoms associated with dysautonomia. A formal clinical diagnosis is not required for inclusion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Madina Town', 'state': 'Fsisalabad', 'country': 'Pakistan', 'facility': 'Integrated Holistic Wellness', 'geoPoint': {'lat': 25.42146, 'lon': 68.3928}}], 'overallOfficials': [{'name': 'Tyson Perez, DC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Life University'}]}, 'ipdSharingStatementModule': {'url': 'https://figshare.com/', 'infoTypes': ['ANALYTIC_CODE'], 'timeFrame': '(start date): within 1 year of study completion. (end date): indefinitely', 'ipdSharing': 'YES', 'description': 'Deidentified IPD necessary to reproduce results', 'accessCriteria': 'IPD, metadata \\& analytic code necessary to reproduce results will be made publicly accessible via a data repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Life University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tyson Perez, DC, PhD', 'investigatorAffiliation': 'Life University'}}}}