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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 weeks
Treatment ~ Varies
Follow Up ~week 1 and week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 and week 4 for reporting.

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 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
~250

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,446 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To which populations is entry into this research endeavor open?

"This clinical trial is currently open to 30 patients who are between 14 and 17 years old and diagnosed with anorexia nervosa. In addition, all participants need to have undergone a standardized refeeding program in the Intensive Program during the intervention (which may include individuals presenting avoidant/restrictive food intake disorder), require gaining at least 8 lbs through this process, be English-speaking, and fall within the mentioned age bracket."

Answered by AI

Are individuals aged 45 and over allowed to participate in this research?

"This clinical trial is exclusive to those between the ages of 14 and 17. There are 70 studies for patients under 18 years old and 73 for those over 65."

Answered by AI

Are there any opportunities for participants to join this experiment?

"According to clinicaltrials.gov, this medical study has concluded recruitment for participants with the most recent update being on November 9th 2022. Despite no longer actively seeking candidates, there are presently 156 other trials which require individuals to partake in their studies."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Department of Psychiatry, Eating and Weight Disorders Program
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Tom Hildebrandt 2022. "Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05554172.
All > Anorexia Nervosa > Eating Disorder
~7 spots leftby Oct 2024
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