Clinical trial NCT07017322: Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
Official title: Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Rogers Behavioral Health
Sponsor class: OTHER
Collaborators: name: Electromedical Products International, Inc.
First posted: 2025-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label pilot
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Percentage of patients who were recruited, enrolled and completed the study
timeFrame: From recruitment to end of study intervention at day 3.
measure: Patient-reported dropout reason
timeFrame: Anytime from enrollment to the end of study intervention at day 3.
measure: Patient-reported side effects
timeFrame: Before the first session on days 2 and 3 of the study intervention.
measure: Patient perception of acceptability as assessed by the Credibility and Expectancy Questionnaire
timeFrame: Baseline, Days 2 and 3 of study intervention.
measure: Percent completion of study data collection
timeFrame: At end of patient's participation and end of admission on inpatient unit.
Secondary outcomes:
measure: Pre-meal anxiety on a visual analogue scale on a scale from 0-10.
timeFrame: Prior to each meal on intervention days 1, 2 and 3.
measure: Eating Disorder Symptoms using the Eating Disorder-15 (ED-15) measure
timeFrame: From enrollment until end of study intervention on day 3.
measure: The Fear of Food Measure (FOFM)
timeFrame: At days 1, 2 and 3 of intervention.
measure: Eating disorder clinical impairment rated on the Clinical Impairment Assessment - Eating only (CIA)
timeFrame: Days 1, 2 and 3 of intervention.
measure: Frequency of use of mealtime interventions for anxiety
timeFrame: Inpatient admission to discharge (average 14 days)
measure: Length of stay in days in the inpatient program
timeFrame: Inpatient admission to discharge (average 14 days).
Other outcomes:
Locations:
city: Oconomowoc
country: United States
facility: Rogers Behavioral Health
state: Wisconsin
Study officials:
References: