Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
Recruiting · NCT07017322 · Interventional (participants receive a specific treatment) · Lead sponsor: Rogers Behavioral Health
View the official record on ClinicalTrials.gov →Interventions studied
Alpha-Stim AID
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.
Who can take part
Age range
18 Years to 30 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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)
Where it is running
1 location listed across 1 US state.
- Rogers Behavioral Health - Oconomowoc, Wisconsin, United States