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

Официальное название

Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 min

Первичные конечные точки

• Percentage of patients who were recruited, enrolled and completed the study [Срок оценки: From recruitment to end of study intervention at day 3.]
• Patient-reported dropout reason [Срок оценки: Anytime from enrollment to the end of study intervention at day 3.]
• Patient-reported side effects [Срок оценки: 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 [Срок оценки: Baseline, Days 2 and 3 of study intervention.]
• Percent completion of study data collection [Срок оценки: At end of patient's participation and end of admission on inpatient unit.]

Вторичные конечные точки (6)

• Pre-meal anxiety on a visual analogue scale on a scale from 0-10. [Срок оценки: Prior to each meal on intervention days 1, 2 and 3.]
• Eating Disorder Symptoms using the Eating Disorder-15 (ED-15) measure [Срок оценки: From enrollment until end of study intervention on day 3.]
• The Fear of Food Measure (FOFM) [Срок оценки: At days 1, 2 and 3 of intervention.]
• Eating disorder clinical impairment rated on the Clinical Impairment Assessment - Eating only (CIA) [Срок оценки: Days 1, 2 and 3 of intervention.]
• Frequency of use of mealtime interventions for anxiety [Срок оценки: Inpatient admission to discharge (average 14 days)]
• Length of stay in days in the inpatient program [Срок оценки: Inpatient admission to discharge (average 14 days).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Rogers Behavioral Health — Oconomowoc

Идентификаторы

NCT: NCT07017322 · RBH-2025-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗