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

NCT ID: NCT06782763

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-09-01

Brief 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 mechanism of cognitive neural circuits.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation device

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

Repetitive transcranial magnetic stimulation device

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

Repetitive transcranial magnetic stimulation device

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

Repetitive transcranial magnetic stimulation device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Cognitive training

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaohua Hu

Role: CONTACT

dorhushaohua@zju.edu.cn

086-13957162903

Facility Contacts

Hu ShaoHua

Role: primary

dorhushaohua@zju.edu.cn

13957162903

Other Identifiers

IIT20240151C

Identifier Type: -

Identifier Source: org_study_id