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rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

NCT ID: NCT05964777

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-04-04

Brief Summary

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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

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Conditions

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Bipolar Disorder in Remission

Keywords

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repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation

Intervention Type DEVICE

with the rapid development of neuroregulatory technology, 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 DLPFC cortical region corresponding to the strongest point of dlpfc and DACC fiber connection as 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.

Repetitive Transcranial magnetic stimulation and sham 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.

Group Type PLACEBO_COMPARATOR

Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation

Intervention Type DEVICE

with the rapid development of neuroregulatory technology, 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 DLPFC cortical region corresponding to the strongest point of dlpfc and DACC fiber connection as 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.

Sham 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.

Group Type PLACEBO_COMPARATOR

Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation

Intervention Type DEVICE

with the rapid development of neuroregulatory technology, 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 DLPFC cortical region corresponding to the strongest point of dlpfc and DACC fiber connection as 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.

Interventions

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Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation

with the rapid development of neuroregulatory technology, 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 DLPFC cortical region corresponding to the strongest point of dlpfc and DACC fiber connection as 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Hu ShaoHua

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ShaoHua Hu, MD

Role: STUDY_DIRECTOR

Zhejiang University

China Zhejiang

Role: STUDY_DIRECTOR

The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh

Locations

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Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ShaoHua Hu, MD

Role: CONTACT

Phone: 13357169115

Email: [email protected]

Xiaomei Zhang

Role: CONTACT

Phone: 13757275095

Email: [email protected]

Facility Contacts

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Hu ShaoHua, MD

Role: primary

Xiaomei Zhang

Role: backup

References

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Wang M, Zhou H, Zhang X, Chen Q, Tong Q, Han Q, Zhao X, Wang D, Lai J, He H, Zhang S, Hu S. Alleviating cognitive impairments in bipolar disorder with a novel DTI-guided multimodal neurostimulation protocol: a double-blind randomized controlled trial. BMC Med. 2025 Jun 4;23(1):334. doi: 10.1186/s12916-025-04174-z.

Reference Type DERIVED
PMID: 40468342 (View on PubMed)

Other Identifiers

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IIT20230058C-R1

Identifier Type: -

Identifier Source: org_study_id