DysautonomiaPAKNCT07481292
Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia
An observational study of Dysautonomia and Dysautonomia Like Disorder, run by Life University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Dysautonomia, Dysautonomia Like Disorder
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Mar 2026to 30 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 5-14 years of age
- Baseline PASS score ≥20
Who cannot join
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysautonomia, Dysautonomia Like Disorder
- Keywords
- Dysautonomia, Pilot Projects, Pediatrics, Complementary Therapies
- Medical subject headings
- Autonomic Nervous System Diseases, Dysautonomia like disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrollees who are eligible to participate
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'.
Measured: From enrollment to baseline PASS submission (up to 48-hours)
Proportion of surveys completed
The number of online surveys submitted within the prespecified time window (72 hours), divided by the total number of online surveys distributed (excludes surveys scheduled after withdrawal). This assesses 'Compliance'
Measured: From enrollment to the end of participation (up to 12 weeks)
Proportion of participants adhering to the care plan
The number of participants attending ≥90% of scheduled remote care sessions , divided by the total number of participants (excludes care sessions scheduled after withdrawal). This assesses 'Adherence'
Measured: From enrollment to the end of participation (up to 12 weeks)
Proportion of participants retained in the study
The number of eligible participants attending the final remote care session, divided by the total number of eligible participants. This assesses 'Retention'.
Measured: From enrollment to the end of the 12 week study period
Secondary outcomes (2)
Change in Pediatric Autonomic Symptom Scales (PASS) scores
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).
Measured: Baseline; ~4 weeks; ~8 weeks; ~12 weeks
Change in Short Sensory Profile (SSP) scores
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).
Measured: Baseline; ~4 weeks; ~8 weeks; ~12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start14 Mar 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysautonomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyson Perez, DC, PhD, Life University
- Investigators
- Tyson Perez, DC, PhD, Principal investigator, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481292
- Sponsor's protocol ID
- EXPTP031326
- Acronym
- PAK
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD necessary to reproduce results
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia: a Pilot Observational Study
- ClinicalTrials.gov ID
- NCT07481292
- Acronym / sponsor ID
- PAK / EXPTP031326
- Conditions
- Dysautonomia, Dysautonomia Like Disorder
- Keywords
- Dysautonomia, Pilot Projects, Pediatrics, Complementary Therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 14 Mar 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 5-14 years of age
- Baseline PASS score ≥20
Key exclusion criteria (1 listed)
- History of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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'.
Proportion of surveys completed
Time frame: From enrollment to the end of participation (up to 12 weeks)
The number of online surveys submitted within the prespecified time window (72 hours), divided by the total number of online surveys distributed (excludes surveys scheduled after withdrawal). This assesses 'Compliance'
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 care sessions , divided by the total number of participants (excludes care sessions scheduled after withdrawal). This assesses 'Adherence'
Proportion of participants retained in the study
Time frame: From enrollment to the end of the 12 week study period
The number of eligible participants attending the final remote care session, divided by the total number of eligible participants. This assesses 'Retention'.
2 secondary outcomes
Change in Pediatric Autonomic Symptom Scales (PASS) scores
Time frame: Baseline; ~4 weeks; ~8 weeks; ~12 weeks
Change in Short Sensory Profile (SSP) scores
Time frame: Baseline; ~4 weeks; ~8 weeks; ~12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD necessary to reproduce results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyson Perez, DC, PhD principal investigator
Life University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysautonomia and Dysautonomia Like Disorder, run by Life University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of enrollees who are eligible to participate (time frame: From enrollment to baseline PASS submission (up to 48-hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.