NCT07017322 · Rogers Behavioral Health
Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 measures
Percentage of patients who were recruited, enrolled and completed the study
Time frame: From recruitment to end of study intervention at day 3.
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.
Patient-reported dropout reason
Time frame: Anytime from enrollment to the end of study intervention at day 3.
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.).
Patient-reported side effects
Time frame: Before the first session on days 2 and 3 of the study intervention.
Patient-reported side effects questionnaire assessing side effects experienced from the intervention day prior.
Patient perception of acceptability as assessed by the Credibility and Expectancy Questionnaire
Time frame: Baseline, Days 2 and 3 of study intervention.
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?
Percent completion of study data collection
Time frame: At end of patient's participation and end of admission on inpatient unit.
Tracking and reporting completeness of all patient-reported outcome data and study data abstracted from electronic medical records.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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)
Where
- Oconomowoc, Wisconsin
Collaborators
Electromedical Products International, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations