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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation | Active Comparator | 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. | |
| Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation | Placebo Comparator | 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 | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS（repeated transcranial magnetic stimulation） | Device | It is a therapeutic technique that utilizes repetitive pulsed magnetic fields applied externally to the skull to act on specific areas of the central nervous system. By altering the membrane potential of cortical neurons, it induces electric currents, which in turn affect brain metabolism and neural electrical activity, leading to a series of physiological and biochemical reactions.on of the therapeutic target. The true stimulation group receives treatment at 100% of the rTMS intensity, while the sham stimulation group receives treatment at 20% of the rTMS intensity. All other parameters are the same. The treatment is conducted from Monday to Friday for a total of three weeks, amounting to 15 sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| thinc-it | 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 | 0,3week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40468342 | Derived | 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. |
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| tACS（transcranial alternating current stimulation） | Device | It is a non-invasive brain stimulation method that involves injecting sinusoidal currents to manipulate and entrain inherent neural oscillations, thereby modulating neural activity. Under true stimulation, the stimulation electrode inputs 2mA, with a stimulation frequency of 40Hz. The other four return electrodes each output 0.5mA. The current fade-in and fade-out time is 10 seconds, and the stimulation duration is 30 minutes. For sham stimulation, the duration is the same as for true stimulation, but only the first and last 20 seconds have real electrical stimulation (i.e., 10 seconds of stimulation at the beginning and end, with no real stimulation during the intervening 29 minutes and 40 seconds). |