Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders

NCT ID: NCT07017322

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-03
• Study Completion Date: 2027-11-01

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.

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.

Conditions

Eating Disorders; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Alpha-Stim AID

Intervention Type: 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).

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).

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Electromedical Products International, Inc.

INDUSTRY

Sponsor Role: collaborator

Rogers Behavioral Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rogers Behavioral Health

Oconomowoc, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hana F Zickgraf, Ph.D.

Role: CONTACT

hana.zickgraf@rogersbh.org

262-303-0170

Facility Contacts

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

Role: primary

hana.zickgraf@rogersbh.org

610-209-7829

Other Identifiers

RBH-2025-03

Identifier Type: -

Identifier Source: org_study_id