High-Definition Personalized Beta-Gamma Electrical Stimulation for Manic Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Beth Israel Deaconess Medical Center, Boston, MA
Manic Disorder+4 More
High-Definition Personalized Beta-Gamma Electrical Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial sought to test whether transcranial magnetic stimulation (TMS) to the right OFC would decrease symptoms of mania. High-Definition Personalized Beta-Gamma Electrical Stimulation is a treatment for Manic Disorder that has been previously approved by the FDA for a different condition.

Eligible Conditions

  • Manic Disorder
  • Schizoaffective Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 10 Secondary · Reporting Duration: Average per year prior to study entry compared to 1 year post study completion

Year 1
Psychiatric Hospitalization for Mania
Change from baseline to 3-month follow-up
Altman Self-Rating Mania Scale (ASRM)
Balloon Analogue Risk Task (BART)
Barratt Impulsiveness Scale-11 (BIS-11)
Brief Assessment of Cognition (BACS)
Electroencephalography (EEG) Resting State
Global Assessment of Functioning (GAF)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Positive and Negative Syndrome Scale (PANSS)
Reinforcement Learning Task
Social Functioning Scale (SFS)
The Go/No Go Task
Young Mania Rating Scale (YMRS)

Trial Safety

Trial Design

3 Treatment Groups

Active HD-tDCS
1 of 3
Personalized Beta-Gamma tACS
1 of 3
Active Control (alpha, 10 Hz)
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

24 Total Participants · 3 Treatment Groups

Primary Treatment: High-Definition Personalized Beta-Gamma Electrical Stimulation · Has Placebo Group · N/A

Personalized Beta-Gamma tACS
Device
Experimental Group · 1 Intervention: High-Definition Personalized Beta-Gamma Electrical Stimulation · Intervention Types: Device
Active Control (alpha, 10 Hz)
Device
ShamComparator Group · 1 Intervention: High-Definition Transcranial Alternate-Current Stimulation · Intervention Types: Device
Active HD-tDCS
Device
ActiveComparator Group · 1 Intervention: High-Definition Transcranial Electrical-Current Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: average per year prior to study entry compared to 1 year post study completion
Closest Location: Beth Israel Deaconess Medical Center · Boston, MA
Photo of Beth Israel Deaconess Medical Center 1Photo of Boston 2Photo of Boston 3
2013First Recorded Clinical Trial
0 TrialsResearching Manic Disorder
1144 CompletedClinical Trials

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
767 Previous Clinical Trials
849,093 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of bipolar disorder or schizoaffective disorder, bipolar type.
You are proficient in English.\n
You have no changes to mood stabilizing medications for a period of 2 weeks prior to participation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.