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Transcranial Electrical Stimulation

Transcranial Electrical Stimulation for Bipolar Disorder

Boston, MA

N/A

Recruiting

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet diagnostic criteria for bipolar disorder or schizoaffective disorder, bipolar type as verified by the SCID

History of mania (>1 lifetime episode)

Must not have

History of seizures

History of head injury with >15 minutes of loss of consciousness/mal sequelae

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average per year prior to study entry compared to 1 year post study completion

Summary

This trial sought to test whether transcranial magnetic stimulation (TMS) to the right OFC would decrease symptoms of mania.

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Who is the study for?

This trial is for adults aged 18-65 with bipolar disorder or schizoaffective disorder, who have experienced mania before and are currently having mild to moderate symptoms. Participants must not have changed their mood stabilizers recently, should not be pregnant or breastfeeding, free from substance abuse in the last six months, and without a history of severe head injury or seizures.Check my eligibility

What is being tested?

Researchers are testing three types of non-invasive brain stimulation: High-Definition Transcranial Electrical-Current Stimulation (HD-tES), Alternate-Current Stimulation (HD-tACS), and Personalized Beta-Gamma Electrical Stimulation. These aim to target specific brain areas linked to mania symptoms like euphoria and risk-taking behaviors.See study design

What are the potential side effects?

Potential side effects may include discomfort at the electrode sites on the scalp, headache, dizziness, nausea or itching under the electrodes during stimulation. There's also a rare risk of inducing seizures with electrical brain stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with bipolar disorder or schizoaffective disorder, bipolar type.

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I have had more than one episode of mania in my life.

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I am between 18 and 65 years old.

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I haven't changed my mood stabilizing medications in the last 2 weeks.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures in the past.

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I have had a head injury with more than 15 minutes of unconsciousness.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average per year prior to study entry compared to 1 year post study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average per year prior to study entry compared to 1 year post study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and average per year prior to study entry compared to 1 year post study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Altman Self-Rating Mania Scale (ASRM)

Psychiatric Hospitalization for Mania

Young Mania Rating Scale (YMRS)

Secondary study objectives

Balloon Analogue Risk Task (BART)

Barratt Impulsiveness Scale-11 (BIS-11)

Brief Assessment of Cognition (BACS)

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Personalized Beta-Gamma tACSExperimental Treatment1 Intervention

10 tACS; Two, twenty-minute sessions of tACS to the OFC for 5 days (10 total sessions).

Group II: Active HD-tDCSActive Control1 Intervention

10 tDCS; Two, twenty-minute sessions of tDCS to the OFC for 5 days (10 total sessions).

Group III: Active Control (alpha, 10 Hz)Placebo Group1 Intervention

10 passive sham control; Two, twenty-minute sessions of passive sham control to the OFC for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).

0 / 6Eligibility criteria met