Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

Not Applicable

Completed

• Conditions: Bipolar Disorder
• Interventions: Device: Sham Repetitive Transcranial magnetic stimulation; Device: Repetitive Transcranial magnetic stimulation

• Registration Number: NCT05929183
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-01
• Study First Posted: 2023-07-03
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Repetitive Transcranial magnetic stimulation	Sham Repetitive Transcranial magnetic stimulation	-
Repetitive Transcranial magnetic stimulation	Repetitive Transcranial magnetic stimulation	-

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale（MADRS）	0-8 weeks	Montgomery-Asberg Depression Rating Scale (MADRS) is used to reflect the effect of antidepressant treatment and monitor the change of patients' condition. The scale is a separate scale, and the score should be based on clinical interviews. The symptoms should be asked from broad to detailed, so as to accurately score the severity. The rater must determine whether the score is on the defined score values (0,2,4,6) or between these scores (1,3,5), according to clinical practice. The scale can be used to score at any time interval.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China