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

Zhejiang University

Status: Enrolling

Conditions: Bipolar Disorder

Treatments: Device: Repetitive transcranial magnetic stimulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT06782763

IIT20240151C

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: All

Ages: 14 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 4 patient groups

rTMS active group and active cognitive training

Experimental group

Description:

Receive 10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of cognitive training at the same time

Treatment:

Device: Repetitive transcranial magnetic stimulation device

rTMS active group and sham cognitive training

Sham Comparator group

Description:

10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of perform simple judgment training at the same time

Treatment:

Device: Repetitive transcranial magnetic stimulation device

rTMS sham group and active cognitive training

Sham Comparator group

Description:

10 Hz, 20 minutes of low-intensity rTMS stimulation; 20 minutes of cognitive training at the same time

Treatment:

Device: Repetitive transcranial magnetic stimulation device

rTMS sham group and sham cognitive training

Sham Comparator group

Description:

10 Hz, 20 minutes of low-intensity rTMS stimulation; perform simple judgment training for 20 minutes at the same time

Treatment:

Device: Repetitive transcranial magnetic stimulation device