Bipolar Disorder in RemissionNCT05964777
rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder
A study testing rTMS（repeated transcranial magnetic stimulation） and tACS（transcranial alternating current stimulation） in people with Bipolar Disorder in Remission, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Bipolar Disorder in Remission
- What is being tested?
- rTMS（repeated transcranial magnetic stimulation） and tACS（transcranial alternating current stimulation）
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 3 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study
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
- Being tested
- rTMS（repeated transcranial magnetic stimulation）, tACS（transcranial alternating current stimulation）
- Keywords
- repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0,3week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jul 2023
- Primary completion3 Jul 2024
- Study completion3 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
- Investigators
- ShaoHua Hu, MD, Study director, First Affiliated Hospital of Zhejiang UniversityChina Zhejiang, Study director, The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964777
- Sponsor's protocol ID
- IIT20230058C-R1
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40468342
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study
- ClinicalTrials.gov ID
- NCT05964777
- Acronym / sponsor ID
- IIT20230058C-R1
- Conditions
- Bipolar Disorder in Remission
- Keywords
- repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS（repeated transcranial magnetic stimulation）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. | Device | – |
| tACS（transcranial alternating current stimulation）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). | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 40468342Wang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ShaoHua Hu, MD study director
First Affiliated Hospital of Zhejiang University
China Zhejiang study director
The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS（repeated transcranial magnetic stimulation） and tACS（transcranial alternating current stimulation） in people with Bipolar Disorder in Remission, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thinc-it (time frame: 0,3week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.