Bipolar DisorderNCT06782763

Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder

A study testing Repetitive transcranial magnetic stimulation device in people with Bipolar Disorder, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. To clarify the efficacy and safety of task-based repetitive transcranial magnetic stimulation (rTMS) on cognitive function in patients with stable bipolar disorder. 2. To analyze the therapeutic mechanism of transcranial magnetic stimulation based on magnetic resonance imaging and explore the abnormal regulation… Read more about this study

Who is it for?: Ages 14 to 45 years
Conditions the study is for: Bipolar Disorder
What is being tested?: Repetitive transcranial magnetic stimulation device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 1 siteChina
Study dates: 20 Dec 2024to 1 Sep 2025
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

Aged 14 to 45 years, right-handed;
Meet the diagnostic criteria for bipolar disorder in the stable remission period of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
Stable medication treatment;
Clinical remission for more than three months, Young Mania Rating Scale (YMRS) ≤ 6 points Hamilton Depression Rating Scale 17 (HDRS 17) score ≤ 7 points;
Cognitive impairment on the Cognitive Deficit Questionnaire (PDQ) ≥ 17 points;
Fully understand the transcranial magnetic stimulation treatment, be willing to actively cooperate with the treatment, and sign the informed consent.

Who cannot join

Those with a history of severe physical illness or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);
Those with neurological diseases or risk of epileptic seizures, such as previous craniocerebral diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or a family history of epilepsy;
Those with contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as those with metal or electronic devices in the body (metal foreign bodies in the brain, cochlear implants, pacemakers and stents);
Those at high risk of suicide, or those who have already committed suicide or serious self-harm and need emergency intervention;
Those who are pregnant, breastfeeding, or planning to become pregnant during the trial;
Those with color blindness or hearing impairment;
Those with a history of substance or alcohol abuse;
Other situations that the researcher determines are not suitable as research subjects.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: A Randomized Controlled Study on the Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder

To clarify the efficacy and safety of task-based repetitive transcranial magnetic stimulation (rTMS) on cognitive function in patients with stable bipolar disorder.
To analyze the therapeutic mechanism of transcranial magnetic stimulation based on magnetic resonance imaging and explore the abnormal regulation mechanism of cognitive neural circuits.

Conditions: Bipolar Disorder
Being tested: Repetitive transcranial magnetic stimulation device
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repetitive transcranial magnetic stimulation deviceDevice
Also called Cognitive training
Activating neurons: rTMS can activate or inhibit neuronal activity in certain brain areas, changing the activity pattern of neural networks. Neuroplasticity: By changing the strength and connection mode of synapses, it promotes the plasticity of the nervous system, which helps treat neuropsychiatric diseases. Regulating neurotransmitters: rTMS can regulate the release of neurotransmitters, affect nerve conduction, and thus improve disease symptoms.

Study groups in NCT06782763
Study group	Role	What they receive
rTMS active group and active cognitive training	Experimental	Receive 10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of cognitive training at the same time Receives: Device: Repetitive transcranial magnetic stimulation device
rTMS active group and sham cognitive training	Sham comparator	10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of perform simple judgment training at the same time Receives: Device: Repetitive transcranial magnetic stimulation device
rTMS sham group and active cognitive training	Sham comparator	10 Hz, 20 minutes of low-intensity rTMS stimulation; 20 minutes of cognitive training at the same time Receives: Device: Repetitive transcranial magnetic stimulation device
rTMS sham group and sham cognitive training	Sham comparator	10 Hz, 20 minutes of low-intensity rTMS stimulation; perform simple judgment training for 20 minutes at the same time Receives: Device: Repetitive transcranial magnetic stimulation device

What is being measured

The primary outcome is the main question the study is designed to answer.

PDQ-21
The Perceived Deficits Questionnaire-21 (PDQ-21) is a widely used self-report scale designed to assess cognitive dysfunction in individuals with various medical and psychiatric conditions. It is particularly valuable in conditions where cognitive impairment, such as problems with memory, attention, and executive functioning, significantly impacts daily life.Total scores range from 0 to 84, with higher scores indicating greater perceived cognitive impairment.
Measured: 0-5 days

Secondary outcomes (1)

brain imaging (MRI)
Functional and structural changes in brain imaging (MRI)
Measured: 0-5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 20241 Sep 2025

First posted20 Jan 2025
Study start20 Dec 2024
Primary completion30 Jun 2025
Study completion1 Sep 2025

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 DisorderStudies of the same condition, open and under way.
More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06782763
Sponsor's protocol ID: IIT20240151C
Status last verified: Dec 2024
First submitted: 1 Jan 2025
Last updated: 27 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wang M, Chen Q, Tang E, Qi S, Tang R, Zhang J, Zhou H, Du L, Chen H, Hu S. State-dependent effects of rTMS on cognitive function in bipolar II disorder: A randomized, double-blind, sham-controlled trial. Mol Psychiatry. 2026 Oct 31. doi: 10.1038/s41380-026-03953-1. Online ahead of print.
PubMed 42966748

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Bipolar Disorder
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Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
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Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain
Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder

All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study on the Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder
ClinicalTrials.gov ID: NCT06782763
Acronym / sponsor ID: IIT20240151C
Conditions: Bipolar Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
Study start: 20 Dec 2024 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 1 Sep 2025 (actual)
First posted: 20 Jan 2025 (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.

To clarify the efficacy and safety of task-based repetitive transcranial magnetic stimulation (rTMS) on cognitive function in patients with stable bipolar disorder.
To analyze the therapeutic mechanism of transcranial magnetic stimulation based on magnetic resonance imaging and explore the abnormal regulation mechanism of cognitive neural circuits.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
rTMS active group and active cognitive training	Experimental	Device: Repetitive transcranial magnetic stimulation deviceReceive 10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of cognitive training at the same time
rTMS active group and sham cognitive training	Sham comparator	Device: Repetitive transcranial magnetic stimulation device10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of perform simple judgment training at the same time
rTMS sham group and active cognitive training	Sham comparator	Device: Repetitive transcranial magnetic stimulation device10 Hz, 20 minutes of low-intensity rTMS stimulation; 20 minutes of cognitive training at the same time
rTMS sham group and sham cognitive training	Sham comparator	Device: Repetitive transcranial magnetic stimulation device10 Hz, 20 minutes of low-intensity rTMS stimulation; perform simple judgment training for 20 minutes at the same time

Who may qualify

Ages: 14 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Aged 14 to 45 years, right-handed;
Meet the diagnostic criteria for bipolar disorder in the stable remission period of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
Stable medication treatment;
Clinical remission for more than three months, Young Mania Rating Scale (YMRS) ≤ 6 points Hamilton Depression Rating Scale 17 (HDRS 17) score ≤ 7 points;
Cognitive impairment on the Cognitive Deficit Questionnaire (PDQ) ≥ 17 points;

Key exclusion criteria (8 listed)

Those with a history of severe physical illness or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);
Those with neurological diseases or risk of epileptic seizures, such as previous craniocerebral diseases, head trauma, alcoholism, abnormal EEG, MRI evidence of abnormal brain structure, or a family history of epilepsy;
Those with contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as those with metal or electronic devices in the body (metal foreign bodies in the brain, cochlear implants, pacemakers and stents);
Those at high risk of suicide, or those who have already committed suicide or serious self-harm and need emergency intervention;
Those who are pregnant, breastfeeding, or planning to become pregnant during the trial;

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
Repetitive transcranial magnetic stimulation deviceAlso: Cognitive trainingActivating neurons: rTMS can activate or inhibit neuronal activity in certain brain areas, changing the activity pattern of neural networks. Neuroplasticity: By changing the strength and connection mode of synapses, it promotes the plasticity of the nervous system, which helps treat neuropsychiatric diseases. Regulating neurotransmitters: rTMS can regulate the release of neurotransmitters, affect nerve conduction, and thus improve disease symptoms.	Device	rTMS active group and active cognitive training, rTMS active group and sham cognitive training, rTMS sham group and active cognitive training, rTMS sham group and sham cognitive training

Primary outcome

PDQ-21
Time frame: 0-5 days
The Perceived Deficits Questionnaire-21 (PDQ-21) is a widely used self-report scale designed to assess cognitive dysfunction in individuals with various medical and psychiatric conditions. It is particularly valuable in conditions where cognitive impairment, such as problems with memory, attention, and executive functioning, significantly impacts daily life.Total scores range from 0 to 84, with higher scores indicating greater perceived cognitive impairment.

1 secondary outcome

brain imaging (MRI)
Time frame: 0-5 days

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 27 May 2026.
Derived from this study: PubMed 42966748Wang M, Chen Q, Tang E, Qi S, Tang R, Zhang J, Zhou H, Du L, Chen H, Hu S. State-dependent effects of rTMS on cognitive function in bipolar II disorder: A randomized, double-blind, sham-controlled trial. Mol Psychiatry. 2026 Oct 31. doi: 10.1038/s41380-026-03953-1. Online ahead of print.

Related trials for Bipolar Disorder

Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingPhase 2
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Bipolar Disorder
RecruitingObservational study
Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions
Esophageal Neoplasm, Esophageal Polyp
Recruiting
Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain
Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive transcranial magnetic stimulation device in people with Bipolar Disorder, 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 6 inclusion and 8 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 27 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?

PDQ-21 (time frame: 0-5 days). 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 NCT06782763, 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 27 May 2026.