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Transcranial Electrical Stimulation

Transcranial Electrical Stimulation for Bipolar Disorder

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)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

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

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Altman Self-Rating Mania Scale (ASRM)

Psychiatric Hospitalization for Mania

Young Mania Rating Scale (YMRS)

Secondary outcome measures

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

836 Previous Clinical Trials

13,010,206 Total Patients Enrolled

2 Trials studying Bipolar Disorder

101 Patients Enrolled for Bipolar Disorder

Media Library

High-Definition Personalized Beta-Gamma Electrical Stimulation (Transcranial Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05445466 — N/A

Bipolar Disorder Research Study Groups: Active HD-tDCS, Active Control (alpha, 10 Hz), Personalized Beta-Gamma tACS

Bipolar Disorder Clinical Trial 2023: High-Definition Personalized Beta-Gamma Electrical Stimulation Highlights & Side Effects. Trial Name: NCT05445466 — N/A

High-Definition Personalized Beta-Gamma Electrical Stimulation (Transcranial Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445466 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I submit my application to join this medical trial?

"To be eligible, candidates must have manic disorder and fall in the age bracket of 18-65. The trial is recruiting up to 24 individuals."

Answered by AI

Are participants of advanced age accepted into this experiment?

"This clinical study is seeking individuals who are of legal age and below the retirement threshold."

Answered by AI

What goals are researchers seeking to achieve by conducting this clinical trial?

"This clinical trial is evaluating the efficacy of a novel intervention using Altman Self-Rating Mania Scale (ASRM) as its primary outcome measure. Secondary outcomes include Electroencephalography (EEG) Resting State, Barratt Impulsiveness Scale-11 (BIS-11), and The Go/No Go Task to assess neural activity, impulsivity, and behavioural responses over 3 months."

Answered by AI

Are participants still being enrolled for this research endeavor?

"As cited on clinicaltrials.gov, this medical trial is no longer recruiting patients. First posted on July 1st 2022 and last updated June 30th 2022, the study has reached its recruitment capacity; nevertheless, 1178 other trials are currently open for enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation

Paulo Lizano 2022. "Causal Lesion Network Guided Treatment of Bipolar Mania With Transcranial Electrical Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445466.

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