Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
Purpose
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.
Conditions
- Eating Disorders
- Anxiety
Eligibility
- Eligible Ages
- Between 18 Years and 30 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Open-label pilot
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Alpha-Stim AID Intervention Arm |
Subjects will receive treatment as usual and non-invasive cranial electrotherapy stimulation (CES) intervention using the Alpha-Stim AID device. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Rogers Behavioral Health
Detailed Description
Evaluate the feasibility and acceptability of a protocol for using Alpha-Stim AID® (explicitly references the patented waveform and delivery method in the Alpha-Stim AID® device manufactured and marketed by Electromedical Products International, Mineral Wells, TX) to manage acute pre-meal anxiety in eating disorder inpatients indicated by recruitment and retention, dropout reasoning, nature and frequency of patient-reported side effects, level of missing patient-reported data, staff perception and patient perception. Secondary outcomes include pre-meal anxiety rated on a 0-10 visual analogue scale, eating disorder symptom severity during the three-session protocol and across the inpatient admission using the Eating Disorder-15 assessment, and clinical impairment from disordered eating using the Clinical Impairment Assessment-Eating only version, across the same timepoints.
