Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

• Sponsor: First Affiliated Hospital of Zhejiang University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05929183
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Device: Repetitive Transcranial magnetic stimulation; Device: Sham Repetitive Transcranial magnetic stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Study of Neuronavigation Occipital rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
• Actual Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Repetitive Transcranial magnetic stimulation	Device: 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.
Sham Comparator: Sham Repetitive Transcranial magnetic stimulation	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 28 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• First Affiliated Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hu ShaoHua, Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Zhejiang University
• ClinicalTrials.gov Identifier: NCT05929183
• Other Study ID Numbers: IIT20220081C-R1
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bipolar Disorder

Study Results

No Results Posted as of Jul 3, 2023