Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia (PAK)

March 17, 2026 updated by: Tyson Perez, DC, PhD, Life University

Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia: a Pilot Observational Study

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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Fsisalabad
      • Madina Town, Fsisalabad, Pakistan, 38000
        • Integrated Holistic Wellness

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 5-14 years of age
  • Baseline PASS score ≥20

Exclusion Criteria:

  • History of epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Children (5-12) with Dysautonomia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of enrollees who are eligible to participate
Time Frame: From enrollment to baseline PASS submission (up to 48-hours)
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'.
From enrollment to baseline PASS submission (up to 48-hours)
Proportion of participants complying with instructions
Time Frame: From enrollment to the end of participation (up to 12 weeks)
The number of participants submitting online surveys within the 48-hour submission window, divided by the total number of participants. This assesses 'Compliance'
From enrollment to the end of participation (up to 12 weeks)
Proportion of participants adhering to the care plan
Time Frame: From enrollment to the end of participation (up to 12 weeks)
The number of participants attending ≥90% of scheduled remote sessions with their CIH practitioner, divided by the total number of participants. This assesses 'Adherence'
From enrollment to the end of participation (up to 12 weeks)
Proportion of participants retained in the study
Time Frame: From enrollment to the end of the 12 week study period
The number of participants submitting the 4th and final online surveys, divided by the total number of participants. This assesses 'Retention'.
From enrollment to the end of the 12 week study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pediatric Autonomic Symptom Scales (PASS) scores
Time Frame: Baseline; ~4 weeks; ~8 weeks; ~12 weeks
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).
Baseline; ~4 weeks; ~8 weeks; ~12 weeks
Change in Short Sensory Profile (SSP) scores
Time Frame: Baseline; ~4 weeks; ~8 weeks; ~12 weeks
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).
Baseline; ~4 weeks; ~8 weeks; ~12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Life University

Investigators

  • Principal Investigator: Tyson Perez, DC, PhD, Life University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPTP031326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified IPD necessary to reproduce results

IPD Sharing Time Frame

(start date): within 1 year of study completion. (end date): indefinitely

IPD Sharing Access Criteria

IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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