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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 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks

Summary

This trial tests a device that sends electrical pulses to a nerve in the ear to help adolescents with eating disorders. The goal is to see if it can improve their eating behaviors by controlling hunger and fullness. Electrical stimulation of this nerve has been used in other treatments and has shown effects on weight.

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Satisfaction Rating Scale
Secondary study objectives
Change in control using a Visual Analogue Scale (VAS)
Change in disgust using a Visual Analogue Scale (VAS)
Change in fear using a Visual Analogue Scale (VAS)
+16 more

Trial 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
~330

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
913 Previous Clinical Trials
572,771 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

taVNS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05554172 — N/A
Anorexia Nervosa Research Study Groups: Vagal Nerve Stimulation (taVNS), Sham Stimulation (Sham)
Anorexia Nervosa Clinical Trial 2023: taVNS Highlights & Side Effects. Trial Name: NCT05554172 — N/A
taVNS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554172 — N/A
~8 spots leftby Oct 2025
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