Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05554172
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
ALL
Age
14 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • taVNS — DEVICE
    Participants will receive vagal nerve stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.
  • Sham — DEVICE
    Participants will receive sham stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.

Study Details

This project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (taVNS) to pre-meal sham stimulation. The aims will assess if taVNS results in greater satisfaction, greater calorie consumption, less self-reported fullness, decrease in eating disorder symptoms, and less anxiety than sham stimulation.

Key Dates

Start date
Dec 13, 2022
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vagal Nerve Stimulation (taVNS)
    taVNS stimulation administered during intervention
  • Sham Comparator: Sham Stimulation (Sham)
    Sham stimulation administered during intervention

Primary Outcome Measure

Satisfaction Rating Scale [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Psychiatry, Eating and Weight Disorders ProgramNew YorkNew York10029
Jessica Bibeau, MA
[email protected]
212-659-8724

Find similar trials in New York, NY

By research site
Department of Psychiatry, Eating and Weight Disorders Program· New York, NY

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