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

Part of paid clinical trials in Oconomowoc, Wisconsin.

Sponsor
Rogers Behavioral Health
Study ID
NCT07017322
Status
Recruiting
Apply to this trial

Conditions

  • Anxiety
  • Eating Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Alpha-Stim AID — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Jun 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alpha-Stim AID Intervention Arm
    Subjects will receive treatment as usual and non-invasive cranial electrotherapy stimulation (CES) intervention using the Alpha-Stim AID device.

Primary Outcome Measure

Percentage of patients who were recruited, enrolled and completed the study [ Time Frame: From recruitment to end of study intervention at day 3. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rogers Behavioral HealthOconomowocWisconsin53066
Hana Zickgraf, Ph.D., M.A., B.A.
[email protected]
610-209-7829
Hana Zickgraf, Ph.D., M.A., B.A. (PRINCIPAL_INVESTIGATOR)

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Rogers Behavioral Health· Oconomowoc, WI

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