RecruitingNot ApplicableNCT05384405

aiTBS for Relieving NSSI in Depressive Patients

Accelerated Intermittent Theta Burst Stimulation for the Treatment of Non-suicidal Self-injury in Patients With Unipolar Depression and Bipolar Depression: a Sham-controlled Study


Sponsor

Central South University

Enrollment

60 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) in patients with unipolar disorder and bipolar disorder.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a type of non-invasive brain stimulation called accelerated intermittent theta burst stimulation (aiTBS) — which uses brief magnetic pulses to stimulate specific brain areas — can reduce self-harm behaviors in teenagers with depression or bipolar disorder. This approach is being explored as an add-on to existing psychiatric care. **You may be eligible if...** - You are between 12 and 18 years old - You have been diagnosed with major depression or bipolar disorder - You have engaged in self-harm (non-suicidal self-injury) at least 3 times in the past 3 months - You are currently receiving psychiatric care **You may NOT be eligible if...** - You use psychoactive drugs or alcohol - You have a severe physical disability that would prevent follow-up - You have another major mental illness in addition to your primary diagnosis - You have a metal implant in your head or skull that would make brain stimulation unsafe 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

DEVICEActive iTBS

MagPro X100

DEVICESham iTBS

MagPro X100


Locations(1)

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, China

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NCT05384405


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