Non-invasive cranial electrical stimulation to reduce mealtime anxiety in adults with eating disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility study tests a protocol using the Alpha‑Stim AID cranial electrotherapy stimulation device delivered over a three‑session protocol to manage acute pre‑meal anxiety in inpatient eating disorder care. Researchers will track recruitment and retention, reasons for dropout, device side effects, missing patient‑reported data, and staff and patient acceptability. Secondary measures include pre‑meal anxiety on a 0–10 visual analogue scale, eating‑disorder symptom scores using the Eating Disorder‑15, and clinical impairment from disordered eating across the inpatient admission. The study is limited to adult inpatients at a single Rogers Behavioral Health site and excludes people with metal implants or certain medications that lower seizure threshold.

Why it matters

Who can join: the full rules

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)

Where it's running

• Rogers Behavioral Health
  Oconomowoc, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: Hana F Zickgraf, Ph.D.
• Email: hana.zickgraf@rogersbh.org
• Phone: 262-303-0170

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single-session intervention to change ambiguity aversion

  This trial tests whether one brief intervention can change how adults with intolerance of uncertainty and anxiety make ambiguous decisions and how their brains respond.

  Recruiting Northwestern University · Chicago, Illinois · NCT06962527

• Personalized emotion regulation skills training

  This study is testing if teaching people personalized ways to manage their emotions can help them feel less negative every day compared to using standard methods.

  Recruiting Ohio State University · Columbus, Ohio · NCT05651295

• National Highly Specialized Care for Severe Self-Harm and Eating Disorders in Swedish Youth

  This observational study tests how well NHV, a highly specialized care program, works for children and teens with severe self-harm or eating disorders by asking patients and their parents about their experiences and what changes they notice.

  Recruiting at 2 sites Karolinska Institutet · Stockholm and 1 other locations · NCT07898059

• See if preoperative anxiety affects recovery after major digestive cancer surgery

  This study tests whether anxiety before surgery is linked to more complications after major digestive cancer operations in French-speaking adults.

  Recruiting University Hospital, Rouen · Rouen · NCT07897942

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• Tele-based wellbeing centres for women's mental health in Bangladesh

  A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.

  Recruiting at 2 sites International Centre for Diarrhoeal Disease Research, Bangladesh · Chāndpur, Matlab Dakshin and 1 other locations · NCT07890896

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.