Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dysautonomia, Dysautonomia Like Disorder. Basic parameters: 5 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Neuro-Emotional Release: Veins and Endocrine System (NERVE) Therapy for Children With Dysautonomia: a Pilot Observational Study
Overview
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.
Primary outcome measures
- Proportion of enrollees who are eligible to participate [Time frame: 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)]
- Proportion of participants adhering to the care plan [Time frame: 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]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 5-14 years of age
- Baseline PASS score ≥20
Exclusion criteria
- History of epilepsy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Pakistan · 1 center
- Integrated Holistic Wellness — Madina Town
Identifiers
NCT: NCT07481292 · EXPTP031326