Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- The First Affiliated Hospital of Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Repetitive Transcranial magnetic stimulation
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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. |
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Sham Comparator: Sham Repetitive Transcranial magnetic stimulation
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The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Montgomery-Asberg Depression Rating Scale（MADRS）
Time Frame: 0-8 weeks
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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.
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0-8 weeks
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT20220081C-R1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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