Cranial Electrical Stimulation for Eating Disorder and Anxiety

Overseen By Hana F Zickgraf, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rogers Behavioral Health

Must not be taking: Seizure threshold reducers

Disqualifiers: Metal in body, Cranial pathologies, Seizure history, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of a non-invasive brain stimulation device, Alpha-Stim AID, to manage anxiety and eating disorder symptoms. The focus is on reducing anxiety before meals and assessing the device's practicality for patients with eating disorders in a specific inpatient program. It suits those enrolled in the eating disorder program at Rogers Behavioral Health in Oconomowoc, WI, who exhibit visible anxiety during meals and require anxiety support. As an unphased trial, this study provides patients the opportunity to explore innovative anxiety management solutions in a supportive environment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication that reduces the seizure threshold, like clomipramine. If you're on such medication, you would need to discontinue it to participate.

What prior data suggests that this device protocol is safe for inpatients with eating disorders?

Research has shown that the Alpha-Stim AID device is generally safe and easy to use. Studies indicate it is effective for treating symptoms like anxiety and depression. It has also been used for other conditions and has demonstrated effectiveness with few serious side effects. Most users experience only minor issues, such as a slight tingling sensation. This suggests the device is safe for managing anxiety and similar symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for eating disorders and anxiety, such as medications and therapy, the Alpha-Stim AID device uses cranial electrotherapy stimulation (CES) to deliver a gentle electrical current to the brain. This non-invasive method is unique because it targets the brain's electrical activity directly, potentially reducing symptoms with fewer side effects. Researchers are excited about this approach because it offers a new way to manage these conditions, especially for those who may not respond well to traditional treatments or seek alternatives with minimal medication involvement.

What evidence suggests that the Alpha-Stim AID device is effective for managing eating disorder and anxiety symptoms?

Research shows that the Alpha-Stim AID device, which provides cranial electrotherapy stimulation (CES), can help reduce anxiety symptoms. One study found it had a moderate effect in easing anxiety for both primary and secondary anxiety issues. Early research with first responders also showed a significant drop in anxiety and related problems, such as trouble sleeping and depression, when using this treatment. However, another study found no major difference between using the Alpha-Stim AID and a placebo device, indicating mixed results. Overall, the Alpha-Stim AID might help lower anxiety, but more research is needed to confirm its effectiveness. Participants in this trial will receive standard treatment along with the Alpha-Stim AID intervention to further evaluate its impact on anxiety and eating disorders. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with eating disorders such as Anorexia Nervosa, Bulimia, Binge Eating Disorder, or Avoidant Restrictive Food Intake Disorder who experience mealtime anxiety. It's designed for inpatients at a treatment facility.

Inclusion Criteria

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

I am between 18 and 30 years old.

Ability to communicate effectively using written and spoken English

Exclusion Criteria

I am taking medication that could make it easier for me to have seizures.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive non-invasive cranial electrotherapy stimulation using the Alpha-Stim AID device to manage acute pre-meal anxiety

3 days

Daily sessions

Inpatient Admission

Participants remain in the inpatient program for eating disorder treatment, with interventions for anxiety and monitoring of eating disorder symptoms

14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alpha-Stim AID

Trial Overview The study tests the Alpha-Stim AID device which provides non-invasive cranial electrical stimulation. The goal is to see if this device can help manage symptoms of eating disorders and reduce anxiety before meals during inpatient care.

How Is the Trial Designed?

Group I: Alpha-Stim AID Intervention Arm Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Rogers Behavioral Health

Lead Sponsor

Trials

3

Recruited

1,200+

Electromedical Products International, Inc.

Industry Sponsor

Trials

6

Recruited

550+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9218324/

Efficacy and Tolerability of Cranial Electrotherapy Stimulation ... We found CES is effective in reducing anxiety symptoms with moderate effect size in patients with both primary and secondary anxiety.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02901080

Clinical and Cost Effectiveness of Alpha-Stim AID CES The primary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for ...

3. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(23)00007-X/fulltext

Clinical effectiveness of active Alpha-Stim AID versus sham ... Fixed daily doses of CES at 100 μA delivered by Alpha-Stim AID for 8 weeks were no more clinically effective than sham Alpha-Stim AID in ...

4. alpha-stim.com alpha-stim.com/research-and-reports/first-responder-research-shows-that-electrical-brain-stimulation-helps-control-anxiety-insomnia-and-depression/?srsltid=AfmBOopsTT2bb8IKNgP_HbO-I9w3t99jI048YaXFuk-jmNy9NZSQwQB9

First responder research shows that electrical brain ... These 86 police officers, sheriff's officers, and firefighters experienced a very significant decrease in anxiety, insomnia, depression, and pain by using Alpha ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01533415

Use of Alpha-Stim Cranial-electrotherapy Stimulation (CES ... Response to treatment will be defined as an improvement of 30% or greater on the HAM-A and HAM-D17 at the endpoint of the study. The impact of prescription ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02901080

Clinical and Cost Effectiveness of Alpha-Stim AID CES The primary objective of this study is to evaluate the clinical effectiveness of treatment with Alpha-Stim AID Cranial Electrotherapy Stimulations (CES) for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882621/

A Critical Review of Cranial Electrotherapy Stimulation for ... A recent open consecutive cohort study demonstrated improvement in anxiety and depression symptoms of generalized anxiety order following 12 and ...

8. alpha-stim.com alpha-stim.com/wp-content/uploads/2016/12/Alpha-Stim-Clinical-Examination-Report.pdf?srsltid=AfmBOoqnjgLeVpg8lJC5ITQ5_TRpj-qsD4QC2Un8btOp3uYVeQnfYEiW

M Microcurrent and Cranial Electrotherapy Stimulator This report presents clinical data and relevant scientific literature for the use, effectiveness and the risk/benefit of the Alpha-Stim® M cranial ...