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rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT05964777
Recruitment Status : Recruiting
First Posted : July 28, 2023
Last Update Posted : July 28, 2023
Sponsor:
Information provided by (Responsible Party):
Hu ShaoHua, First Affiliated Hospital of Zhejiang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder in Remission Device: Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : March 3, 2024
Estimated Study Completion Date : April 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.

 Device: 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.
Placebo Comparator: 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.

 Device: 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.
Placebo Comparator: 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.

 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. thinc-it [ Time Frame: 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05964777


Contacts
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Contact: ShaoHua Hu, MD 13357169115 ext 86 dorhushaohua@zju.deu.cn
Contact: Xiaomei Zhang 13757275095 ext 86 zxm11982012@sina.com

Locations
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China, Zhejiang
Department of Psychiatry, First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Hu ShaoHua, MD    13957162903    dorhushaohua@zju.edu.cn   
Contact: Xiaomei Zhang    zxm11982012@sina.com    zxm11982012@sina.com   
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Investigators
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Study Director: ShaoHua Hu, MD Zhejiang University
Study Director: China Zhejiang The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh
More Information
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Responsible Party: Hu ShaoHua, Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT05964777    
Other Study ID Numbers: IIT20230058C-R1
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hu ShaoHua, First Affiliated Hospital of Zhejiang University:
repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mood Disorders
Mental Disorders