Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders
Rogers Behavioral Health
30 participants
Jun 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Age 18-30 years old at the time of enrollment
- Enrolled in Rogers Behavioral Health Eating Disorder Recovery Program Inpatient Unit at the Oconomowoc, WI clinic location
- 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)
- Ability to communicate effectively using written and spoken English
- 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
Exclusion Criteria7
- Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
- Currently taking medication that reduces seizure threshold (e.g., clomipramine)
- Cranial pathologies (e.g., holes, plates)
- History of seizure or black-out concussion
- Pregnancy
- Risk of suicide/self-harm by self-strangulation with cranial electrotherapy stimulation (CES) device judged by study medical staff
- Participant calibrates to a stimulation level below 200 microampere (μA)
Interventions
Subjects will receive non-invasive cranial electrotherapy stimulation (CES) treatment in 20-minute group sessions taking place immediately prior to breakfast, lunch, and dinner. This study uses the Alpha-Stim AID® CES device which will be set to the highest amplitude that is tolerated by the participant (with a minimum of 200 microampere (µA) and a maximum of 500 µA stimulation) at 0.5 hertz for a duration of 20 minutes per session, 3 sessions per day, for 3 separate days of stimulation (180 minutes of stimulation total).
Locations(1)
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NCT07017322