Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders (NCT07017322) | Clinical Trial Compass
RecruitingNot Applicable
Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
United States30 participantsStarted 2025-06-03
Plain-language summary
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.
Who can participate
Age range18 Years â 30 Years
SexALL
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Inclusion criteria
â. Age 18-30 years old at the time of enrollment
â. Enrolled in Rogers Behavioral Health Eating Disorder Recovery Program Inpatient Unit at the Oconomowoc, WI clinic location
â. 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)
â. Ability to communicate effectively using written and spoken English
â. Participant is eligible for mealtime anxiety support based on:
Exclusion criteria
â. Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
â. Currently taking medication that reduces seizure threshold (e.g., clomipramine)
â. Cranial pathologies (e.g., holes, plates)
â. History of seizure or black-out concussion
What they're measuring
1
Percentage of patients who were recruited, enrolled and completed the study
Timeframe: From recruitment to end of study intervention at day 3.
2
Patient-reported dropout reason
Timeframe: Anytime from enrollment to the end of study intervention at day 3.
3
Patient-reported side effects
Timeframe: Before the first session on days 2 and 3 of the study intervention.
4
Patient perception of acceptability as assessed by the Credibility and Expectancy Questionnaire
Timeframe: Baseline, Days 2 and 3 of study intervention.
5
Percent completion of study data collection
Timeframe: At end of patient's participation and end of admission on inpatient unit.