RecruitingNot ApplicableNCT06524505

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial


Sponsor

Tianjin Anding Hospital

Enrollment

100 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. We hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain stimulation technique called deep transcranial magnetic stimulation (deep TMS) as a treatment for bipolar depression. Unlike traditional antidepressants, deep TMS uses magnetic pulses to stimulate targeted regions of the brain. Researchers are also looking at whether this treatment affects thinking and memory. **You may be eligible if...** - You have a confirmed diagnosis of bipolar depression - You are between 18 and 65 years old - Your depression symptoms are moderate to severe (score of 17 or higher on a standard scale) - You have been on a stable medication regimen for at least 4 weeks before starting treatment **You may NOT be eligible if...** - You have a history of other psychiatric disorders, significant neurological disease, or severe brain injury - You have received electroconvulsive therapy or other brain stimulation treatments in the past 3 months - You have epilepsy, heart or blood vessel disorders, or metal implants in your head - You are currently experiencing manic or hypomanic symptoms - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEdeep Transcranial Magnetic Stimulation (dTMS) -active

with the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).

DEVICEdeep Transcranial Magnetic Stimulation (dTMS) -sham

The sham stimulation was performed using the same procedures, with the sham coil.


Locations(1)

Tianjin Anding Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06524505


Related Trials