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Tests treatment safety and results for Anorexia Nervosa
Official title Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
ClinicalTrials.gov ID: NCT05554172
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 22
You may be able to join if
- Ages 14-22
- Engaged in standardized refeeding in the EWDP during the intervention (may include individuals with anorexia nervosa or avoidant/restrictive food...
- Needing to gain at least 8 lbs during the refeeding period
- English-speaking
You likely can't join if
- Pregnancy
- GI disturbance or diagnosis (Crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or suspected or known GI obstruction)
- GI surgery in the last 3 months
- Implanted or portable electro-mechanical device such as a pacemaker, defibrillator, or infusion pump
- Allergies to the ingredients in the shake provided
- Use of illicit substances including misuse, overuse, abuse, illegal use, or addiction to or dependence on
See the full eligibility criteria
- Ages 14-22
- Engaged in standardized refeeding in the EWDP during the intervention (may include individuals with anorexia nervosa or avoidant/restrictive food intake disorder)
- Needing to gain at least 8 lbs during the refeeding period
- English-speaking
- Pregnancy
- GI disturbance or diagnosis (Crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or suspected or known GI obstruction)
- GI surgery in the last 3 months
- Implanted or portable electro-mechanical device such as a pacemaker, defibrillator, or infusion pump
- Allergies to the ingredients in the shake provided
- Use of illicit substances including misuse, overuse, abuse, illegal use, or addiction to or dependence on
- Acute suicide risk/active suicidal ideation determined with the C-SSRS. "Yes" to questions 1 or 2 in the Suicidal Ideation section or "Yes" to any question in the Suicidal Behavior section will be exclusionary
- Psychiatric diagnoses of schizophrenia or bipolar disorder
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.