RecruitingNot ApplicableNCT07021508

Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression

Efficacy and Safety Assessment of Temporal Interference Stimulation to Improve Bipolar Depression: a Randomized Controlled Study


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

160 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study was to explore the efficacy and safety of temporal interference stimulation to improve bipolar depression, as well as to explore the corresponding neuroimaging mechanisms using magnetic resonance and electroencephalogram to provide novel intervention protocols and objective indicators of efficacy prediction for depressive episodes in bipolar disorder.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain stimulation technique called temporal interference stimulation (a non-invasive type of electrical brain stimulation using electrodes placed on the scalp) to see if it can reduce depression in people with bipolar disorder. **You may be eligible if...** - You are right-handed and have completed at least 9 years of education - You have been diagnosed with bipolar depression (DSM-5 criteria) - Your depression is moderate-to-severe (HAMD-17 score of 18 or more) - Your manic symptoms are low (YMRS score 8 or less) - You have either not been on psychiatric medication, or are willing to undergo a 2-week medication washout before the study **You may NOT be eligible if...** - You have metal implants or other contraindications to MRI scanning - You have a history of seizures or certain neurological conditions - 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.

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Interventions

DEVICETemporal Interference Stimulation

A non-invasive, non-invasive method of deep brain electrical stimulation utilizing high-frequency electric field interactions to produce a low-frequency envelope to modulate neural activity.

DEVICESham Temporal Interference Stimulation

The same machine was used as the temporal Interferenc real stimulus, with current creep only 20 seconds before stimulus onset to simulate the real stimulus sensation.


Locations(1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

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NCT07021508


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