RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-03
Study Completion:2027-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07017322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18-30 years old at the time of enrollment
  2. 2. Enrolled in Rogers Behavioral Health Eating Disorder Recovery Program Inpatient Unit at the Oconomowoc, WI clinic location
  3. 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. 4. Ability to communicate effectively using written and spoken English
  5. 5. Participant is eligible for mealtime anxiety support based on:
  6. * ≤ 75% meal plan compliance
  7. * Visible anxiety/distress during program meals
  8. * Engagement in compensatory behaviors or self-harm before, during, or after meals, or medical staff judge patient to be at risk of same
  1. 1. Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
  2. 2. Currently taking medication that reduces seizure threshold (e.g., clomipramine)
  3. 3. Cranial pathologies (e.g., holes, plates)
  4. 4. History of seizure or black-out concussion
  5. 5. Pregnancy
  6. 6. Risk of suicide/self-harm by self-strangulation with cranial electrotherapy stimulation (CES) device judged by study medical staff
  7. 7. Participant calibrates to a stimulation level below 200 microampere (μA)

Contacts and Locations

Study Contact

Hana F Zickgraf, Ph.D.
CONTACT
262-303-0170
hana.zickgraf@rogersbh.org

Study Locations (Sites)

Rogers Behavioral Health
Oconomowoc, Wisconsin, 53066
United States

Collaborators and Investigators

Sponsor: Rogers Behavioral Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03
Study Completion Date2027-11-01

Study Record Updates

Study Start Date2025-06-03
Study Completion Date2027-11-01

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Eating Disorders
  • Anxiety