Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

Zhejiang University

Status: Completed

Conditions: Bipolar Disorder

Treatments: Device: Sham Repetitive Transcranial magnetic stimulation; Device: Repetitive Transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05929183

IIT20220081C-R1

Details and patient eligibility

About

The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.

Enrollment: 40 patients

Sex: All

Ages: 14 to 28 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 14-28 years old, regardless of gender;
2. Meet DSM-V diagnostic criteria for bipolar depressive episodes;
3. Young Mania Rating Scale (YMRS) ≤ 6 points;
4. MARDS:12-30 points.
5. Han nationality, right-handed;
6. More than 9 years of education.

Exclusion criteria

1. History of severe somatic or brain organic diseases and craniocerebral trauma;
2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
3. Those who do not cooperate or cannot effectively complete the experiment;
4. Drug, alcohol or other psychoactive substance abusers;
5. Pregnant, lactating or planned pregnancy.
6. Severe suicidal ideation and behavior
7. ECT or rTMS treatment was performed within six months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Repetitive Transcranial magnetic stimulation

Active Comparator group

Treatment:

Device: Repetitive Transcranial magnetic stimulation

Sham Repetitive Transcranial magnetic stimulation

Sham Comparator group

Treatment:

Device: Sham Repetitive Transcranial magnetic stimulation