rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder

NCT05964777 | Completed

• 1 other identifier: IIT20230058C-R1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder in Remission

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Interventions

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.

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).

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• History of severe somatic or brain organic diseases and craniocerebral trauma;
• Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
• Those who do not cooperate or cannot effectively complete the experiment;
• Drug, alcohol or other psychoactive substance abusers;
• Pregnant, lactating or planned pregnancy;
• ECT or rTMS or tACS treatment was performed within six months.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• 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.

  PMID: 40468342 DERIVED

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: July 1, 2023
• Primary Completion: July 3, 2024
• Study Completion: August 3, 2024
• Last Updated: May 28, 2026

Record last verified: 2023-07

Locations

CN (1)