Non-invasive cranial electrical stimulation to reduce mealtime anxiety in adults with eating disorders
Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders
This trial will try using the Alpha‑Stim AID cranial electrical stimulation device to see if it lowers pre-meal anxiety in adults aged 18–30 who are hospitalized for eating disorders.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Rogers Behavioral Health Academic / other |
| Locations | 1 site (Oconomowoc, Wisconsin) |
| Trial ID | NCT07017322 on ClinicalTrials.gov |
What this trial studies
This feasibility study tests a protocol using the Alpha‑Stim AID cranial electrotherapy stimulation device delivered over a three‑session protocol to manage acute pre‑meal anxiety in inpatient eating disorder care. Researchers will track recruitment and retention, reasons for dropout, device side effects, missing patient‑reported data, and staff and patient acceptability. Secondary measures include pre‑meal anxiety on a 0–10 visual analogue scale, eating‑disorder symptom scores using the Eating Disorder‑15, and clinical impairment from disordered eating across the inpatient admission. The study is limited to adult inpatients at a single Rogers Behavioral Health site and excludes people with metal implants or certain medications that lower seizure threshold.
Who should consider this trial
Good fit: Ideal candidates are adults 18–30 admitted to the Rogers Behavioral Health Oconomowoc inpatient eating disorder program with a DSM‑5 eating disorder who show visible mealtime anxiety, low meal compliance (≤75%), or compensatory behaviors around meals.
Not a fit: Patients with metal implants, implanted devices, or on medications that lower seizure threshold, those outside the 18–30 age range, or patients without clinically significant mealtime anxiety are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer a non‑drug option to reduce pre‑meal anxiety and help patients engage more effectively with inpatient eating disorder treatment.
How similar studies have performed: Cranial electrotherapy stimulation and Alpha‑Stim devices have shown small positive effects on anxiety in prior small trials, but using CES specifically for inpatient mealtime anxiety in eating disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Oconomowoc, Wisconsin
- Rogers Behavioral Health — Oconomowoc, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Hana F Zickgraf, Ph.D.
- Email: hana.zickgraf@rogersbh.org
- Phone: 262-303-0170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.