Recruiting

Non-Invasive Brain Stimulation

Sponsor:

Rogers Behavioral Health

Code:

NCT07017322

Conditions

Eating Disorders

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Alpha-Stim AID

Study Details

Brief summary:

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

Study ID

NCT07017322

Start date

Jun 3, 2025

Status verified date

Aug, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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).

Primary outcome measure

  • Percentage of patients who were recruited, enrolled and completed the study [ Time Frame: From recruitment to end of study intervention at day 3. ]
  • Patient-reported dropout reason [ Time Frame: Anytime from enrollment to the end of study intervention at day 3. ]
  • Patient-reported side effects [ Time Frame: Before the first session on days 2 and 3 of the study intervention. ]
  • Patient perception of acceptability as assessed by the Credibility and Expectancy Questionnaire [ Time Frame: Baseline, Days 2 and 3 of study intervention. ]
  • Percent completion of study data collection [ Time Frame: At end of patient's participation and end of admission on inpatient unit. ]

Central Contacts and Locations

Central contacts

Hana F Zickgraf, Ph.D.

262-303-0170hana.zickgraf@rogersbh.org

Locations

Rogers Behavioral Health

Recruiting

Oconomowoc, Wisconsin, United States, 53066

Contacts

Hana Zickgraf, Ph.D., M.A., B.A.

610-209-7829hana.zickgraf@rogersbh.org

Principal Investigator:

Hana Zickgraf, Ph.D., M.A., B.A.

More Information

Sponsor

Rogers Behavioral Health

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • electrotherapy stimulation
  • Alpha-Stim AID
  • cranial electrotherapy stimulation
  • CES
  • meal anxiety
  • Non-invasive cranial electrotherapy stimulation
  • Inpatient weight restoration
  • avoidant restrictive food intake disorder
  • other specified feeding or eating disorder
  • anorexia nervosa
  • bulimia nervosa
  • purging disorder
  • binge eating disorder
  • ARFID
  • OSFED
  • procedural anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rogers Behavioral Health on 2026-08-12.