RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 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 Exclusion Criteria: 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)

Treatments Being Tested

DEVICE

Alpha-Stim AID

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)

Rogers Behavioral Health

Oconomowoc, Wisconsin, United States