Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders
Start Date
6/3/2025
Completion Date
11/1/2027
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
Age Range: 18 years to 30 years
Interventions
Alpha-Stim AID
Conditions
Locations
Rogers Behavioral Health
Oconomowoc, Wisconsin 53066
United States