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Device
Vagus Nerve Stimulation for Anorexia
N/A
Recruiting
Led By Tom Hildebrandt, PsyD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 and week 4
Awards & highlights
Study Summary
This trial will compare the effects of pre-meal vagal nerve stimulation to sham stimulation on satisfaction, calorie consumption, self-reported fullness, anxiety, and eating disorder symptoms. Gastric parameters will also be measured.
Who is the study for?
This trial is for English-speaking teens aged 14-17 with low weight eating disorders, who are in a refeeding program and need to gain at least 8 lbs. It's not for those pregnant, with recent GI surgery, acute suicide risk, swallowing disorders, schizophrenia or bipolar disorder, certain device implants (like pacemakers), allergies to specific shake ingredients, substance misuse issues or diagnosed GI disturbances.Check my eligibility
What is being tested?
The study tests if non-invasive vagus nerve stimulation (taVNS) before meals can improve satisfaction and calorie intake while reducing fullness feelings and anxiety compared to sham (fake) stimulation. It also measures gastric functions like rhythm and motility over four weeks.See study design
What are the potential side effects?
While the document doesn't specify side effects of taVNS directly, similar treatments may cause discomfort at the stimulation site, headache, voice changes or throat tingling during active treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1 and week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 and week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Satisfaction Rating Scale
Secondary outcome measures
Change in Motility time
Change in control using a Visual Analogue Scale (VAS)
Change in disgust using a Visual Analogue Scale (VAS)
+19 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vagal Nerve Stimulation (taVNS)Experimental Treatment1 Intervention
taVNS stimulation administered during intervention
Group II: Sham Stimulation (Sham)Placebo Group1 Intervention
Sham stimulation administered during intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
taVNS
2011
Completed Phase 4
~250
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,221 Total Patients Enrolled
5 Trials studying Anorexia Nervosa
296 Patients Enrolled for Anorexia Nervosa
Tom Hildebrandt, PsyDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
5 Previous Clinical Trials
651 Total Patients Enrolled
1 Trials studying Anorexia Nervosa
90 Patients Enrolled for Anorexia Nervosa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have trouble swallowing food or pills.I have a diagnosed gastrointestinal condition like Crohn's or IBS.I failed the Jelly Bean Test.I am between 14 and 17 years old.I am currently in a program for eating disorders, focusing on refeeding.I have not had GI surgery in the last 3 months.I cannot swallow the SmartPill.
Research Study Groups:
This trial has the following groups:- Group 1: Vagal Nerve Stimulation (taVNS)
- Group 2: Sham Stimulation (Sham)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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