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Enrolling by Invitation

NCT Number: NCT07481292

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

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.

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Key information

Conditions

Dysautonomia Autonomic Nervous System Diseases Dysautonomia Like Disorder Nervous System Diseases

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Integrated Holistic Wellness

Madina Town, Fsisalabad, 38000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of epilepsy

Treatment and study plan

Primary outcomes

  1. 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'.

  2. 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'

  3. 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'

  4. 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'.

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Life University

Other

Registry information

Official study title

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

Acronym: PAK

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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