What this study is
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.
What's being tested
- Alpha-Stim AID
Intervention · DEVICE
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).
Study details
- Official title
- Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders
- Sponsor
- Rogers Behavioral Health
- Conditions
- Eating Disorders · Anxiety
- Enrolling
- 30 people
- Starts
- 2025-06-03
- Est. completion
- 2027-11-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 30 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRogers Behavioral Health
Oconomowoc, Wisconsin, United States
- Hana Zickgraf, Ph.D., M.A., B.A. · Contact610-209-7829hana.zickgraf@rogersbh.org
- Hana Zickgraf, Ph.D., M.A., B.A. · Principal investigator
Recruiting
Study team
Sponsor
Rogers Behavioral Health
Study ID RBH-2025-03
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.