Actively Recruiting

Phase Not Applicable
Age: 18Years - 30Years
All Genders
NCT07017322

Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders

Led by Rogers Behavioral Health · Updated on 2025-06-12

30

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

Sponsors

R

Rogers Behavioral Health

Lead Sponsor

E

Electromedical Products International, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The study is to evaluate the feasibility of using a non-invasive brain stimulation device in a sample of inpatients with eating disorders (ED). The study will help researchers evaluate whether their device protocol is practical for eating disorder inpatients as a way to manage eating disorder and anxiety symptoms. A secondary aim of the study is to evaluate preliminary effectiveness of the protocol for reducing pre-meal anxiety during the treatment, and explore effects on eating disorder symptoms over the course of the inpatient admission.

CONDITIONS

Official Title

Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders

Who Can Participate

Age: 18Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. Age 18-30 years old at the time of enrollment

  2. Enrolled in Rogers Behavioral Health Eating Disorder Recovery Program Inpatient Unit at the Oconomowoc, WI clinic location

  3. Have a primary diagnosis of any DSM-5 eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant/restrictive food intake disorder, other specified feeding or eating disorder)

  4. Ability to communicate effectively using written and spoken English

  5. Participant is eligible for mealtime anxiety support based on:

    • ≤ 75% meal plan compliance
    • Visible anxiety/distress during program meals
    • Engagement in compensatory behaviors or self-harm before, during, or after meals, or medical staff judge patient to be at risk of same
Not Eligible

You will not qualify if you...

  1. Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
  2. Currently taking medication that reduces seizure threshold (e.g., clomipramine)
  3. Cranial pathologies (e.g., holes, plates)
  4. History of seizure or black-out concussion
  5. Pregnancy
  6. Risk of suicide/self-harm by self-strangulation with cranial electrotherapy stimulation (CES) device judged by study medical staff
  7. Participant calibrates to a stimulation level below 200 microampere (μA)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rogers Behavioral Health

Oconomowoc, Wisconsin, United States, 53066

Actively Recruiting

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Research Team

H

Hana F Zickgraf, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders | DecenTrialz