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

NCT07017322 | Recruiting FDA Device

• 1 other identifier: RBH-2025-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (5)

• Percentage of patients who were recruited, enrolled and completed the study

  The percentage of eligible patients approached for recruitment, percentage of recruited patients enrolled, and percentage of enrolled patients completing the study, each as recorded by study staff.

  From recruitment to end of study intervention at day 3.

• Patient-reported dropout reason

  The patient's self-reported rationale for leaving the study prematurely (e.g., unexpected discharge from inpatient eating disorder treatment, unable to tolerate stimulation, emergent suicidality, unwilling to participate in the protocol, etc.).

  Anytime from enrollment to the end of study intervention at day 3.

• Patient-reported side effects

  Patient-reported side effects questionnaire assessing side effects experienced from the intervention day prior.

  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

  The Credibility and Expectancy Questionnaire is a 6-item self-report survey used to assess patients' belief and expectation that they will benefit from a treatment. We will use two questions from the scale to assess how much the participant believes the treatment makes sense, and how strongly they feel it will help them. It is rated on a 10-point scale with anchors 1-9 (not at all (1), somewhat (5), very (9)). The two questions from the CEQ will be as follows: 1. How logical does cranial electrical stimulation for pre-meal anxiety seem? 2. How successful do you think cranial electrical stimulation will be in reducing your pre-meal anxiety?

  Baseline, Days 2 and 3 of study intervention.

• Percent completion of study data collection

  Tracking and reporting completeness of all patient-reported outcome data and study data abstracted from electronic medical records.

  At end of patient's participation and end of admission on inpatient unit.

Secondary Outcomes (6)

• Pre-meal anxiety on a visual analogue scale on a scale from 0-10.

  Prior to each meal on intervention days 1, 2 and 3.

• Eating Disorder Symptoms using the Eating Disorder-15 (ED-15) measure

  From enrollment until end of study intervention on day 3.

• The Fear of Food Measure (FOFM)

  At days 1, 2 and 3 of intervention.

• Eating disorder clinical impairment rated on the Clinical Impairment Assessment - Eating only (CIA)

  Days 1, 2 and 3 of intervention.

• Frequency of use of mealtime interventions for anxiety

  Inpatient admission to discharge (average 14 days)

Study Arms (1)

Alpha-Stim AID Intervention Arm

EXPERIMENTAL

Subjects will receive treatment as usual and non-invasive cranial electrotherapy stimulation (CES) intervention using the Alpha-Stim AID device.

Device: Alpha-Stim AID

Interventions

Alpha-Stim AID 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).

Alpha-Stim AID Intervention Arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rogers Behavioral Health: lead
• Electromedical Products International, Inc.: collaborator

Study Sites (1)

Rogers Behavioral Health

Oconomowoc, Wisconsin, 53066, United States

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders; Anxiety Disorders; Avoidant Restrictive Food Intake Disorder; Anorexia Nervosa; Bulimia Nervosa; Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Hana F Zickgraf, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label pilot

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: June 12, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)