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

May 25, 2026 updated by: First Affiliated Hospital of Zhejiang University

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

  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 mechanism of cognitive neural circuits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 14 to 45 years, right-handed;
  2. 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);
  3. Stable medication treatment;
  4. Clinical remission for more than three months, Young Mania Rating Scale (YMRS) ≤ 6 points Hamilton Depression Rating Scale 17 (HDRS 17) score ≤ 7 points;
  5. Cognitive impairment on the Cognitive Deficit Questionnaire (PDQ) ≥ 17 points;
  6. Fully understand the transcranial magnetic stimulation treatment, be willing to actively cooperate with the treatment, and sign the informed consent.

Exclusion Criteria:

  1. Those with a history of severe physical illness or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);
  2. 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;
  3. 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);
  4. Those at high risk of suicide, or those who have already committed suicide or serious self-harm and need emergency intervention;
  5. Those who are pregnant, breastfeeding, or planning to become pregnant during the trial;
  6. Those with color blindness or hearing impairment;
  7. Those with a history of substance or alcohol abuse;
  8. Other situations that the researcher determines are not suitable as research subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS active group and active cognitive training
Receive 10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of cognitive training at the same time
Device: Repetitive transcranial magnetic stimulation device
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.
Other Names:
  • Cognitive training
Sham Comparator: rTMS active group and sham cognitive training
10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of perform simple judgment training at the same time
Device: Repetitive transcranial magnetic stimulation device
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.
Other Names:
  • Cognitive training
Sham Comparator: rTMS sham group and active cognitive training
10 Hz, 20 minutes of low-intensity rTMS stimulation; 20 minutes of cognitive training at the same time
Device: Repetitive transcranial magnetic stimulation device
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.
Other Names:
  • Cognitive training
Sham Comparator: rTMS sham group and sham cognitive training
10 Hz, 20 minutes of low-intensity rTMS stimulation; perform simple judgment training for 20 minutes at the same time
Device: Repetitive transcranial magnetic stimulation device
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.
Other Names:
  • Cognitive training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brain imaging (MRI)
Time Frame: 0-5 days
Functional and structural changes in brain imaging (MRI)
0-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

September 1, 2025

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT20240151C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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