Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

14 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

repetitive transcranial magnetic stimulation

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

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.

Primary outcomes

Montgomery-Asberg Depression Rating Scale（MADRS）

Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Jul 3, 2023
Registry last updated: May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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