Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

NCT ID: NCT05929183

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-07-01

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Repetitive Transcranial magnetic stimulation

Group Type: ACTIVE_COMPARATOR

Repetitive Transcranial magnetic stimulation

Intervention Type: DEVICE

Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of depressive symptom was dorsolateral prefrontal cortex (DLPFC). In this study, we use high frequency rTMS in the occipital lobe are precisely targeted by navigation, by stimulating the primary visual cortex（V1), can affect the orbitofrontal cortex (OFC), which is functionally connected to V1, and thus affect the entire nerve ring pathway excitability, thereby rapidly, effectively and safely improving mood symptoms in the acute phase of bipolar depressive episode.

After the target was determined by fMRI navigation and positioning, the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.

Sham Repetitive Transcranial magnetic stimulation

Group Type: SHAM_COMPARATOR

Sham Repetitive Transcranial magnetic stimulation

Intervention Type: DEVICE

The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm.

Interventions

Repetitive Transcranial magnetic stimulation

Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of depressive symptom was dorsolateral prefrontal cortex (DLPFC). In this study, we use high frequency rTMS in the occipital lobe are precisely targeted by navigation, by stimulating the primary visual cortex（V1), can affect the orbitofrontal cortex (OFC), which is functionally connected to V1, and thus affect the entire nerve ring pathway excitability, thereby rapidly, effectively and safely improving mood symptoms in the acute phase of bipolar depressive episode.

After the target was determined by fMRI navigation and positioning, the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.

Intervention Type: DEVICE

Sham Repetitive Transcranial magnetic stimulation

The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Hu ShaoHua

Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

IIT20220081C-R1

Identifier Type: -

Identifier Source: org_study_id