rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

Not Applicable

Recruiting

• Conditions: Bipolar Disorder in Remission
• Interventions: Device: Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation

• Registration Number: NCT05964777
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

Based on the individualized positioning technology of diffusion tensor imaging (DTI), the purpose of this study is to explore a new stimulation target and protocol for the treatment of bipolar disorder in remission through the repetitive transcranial magnetic stimulation(rTMS) and transcranial alternating current stimulation（tACS）under neuronavigation，verify whether there is abnormal functional connectivity and structural connections between the dorsolateral prefrontal cortex (dlpfc) and the dorsal anterior cingulate gyrus (dacc) related to cognitive impairment in bipolar disorder in remission, which will contribute to further understand the relevant neural pathway and mechanism.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Primary Completion: 2024-03-03
• Study Completion: 2024-04-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• 1. Age 14-45 years old, regardless of gender] 2.Meet DSM-V diagnostic criteria for bipolar depressive in remission 3.Young Mania Rating Scale (YMRS) ≤ 6 points; 4.Hamilton Depression Scale(HAMD-17)≤7 points; 5.Cognitive deficit questionnaire PDQ≥17 points; 6.Han nationality, right-handed; 7.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. ECT or rTMS or tACS treatment was performed within six months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation	Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation	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. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under sham stimulation, the current fade in and out time is 10 seconds, the other 29 minutes and 40 seconds, no real current passes through.
Sham repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation	Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation	The stimulus intensity was 20% of MT in the ShamComparator arm, and the remaining parameters were the same as the Active Comparator arm. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.
Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation	Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation	rTMS and tACS have a profound impact on cognitive impairment.,The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.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. tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.

Primary Outcome Measures

Name	Time	Method
thinc-it	0,3week	THINC-it test suites: Used primarily to assess cognitive dimensions such as executive function, learning and memory, attention, and processing speed in patients with BD. The assessment was conducted before and after treatment, and consisted of five main parts:Spotter,Symbol Check,Code Breaker,Trails test,PDQ-5-D

Trial Locations

Locations (1)

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