Using rTMS to Improve Cognitive Function in Bipolar Disorder

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

This study is testing if a special brain treatment called rTMS can help improve thinking skills in people with stable bipolar disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 14 Years to 45 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06782763 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of task-activated repetitive transcranial magnetic stimulation (rTMS) in enhancing cognitive function among patients with stable bipolar disorder. It aims to clarify the therapeutic mechanisms of rTMS through magnetic resonance imaging and to investigate the abnormal regulation of cognitive neural circuits. Participants will undergo rTMS treatment while their cognitive performance is assessed, focusing on those in a stable remission phase of their condition.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 14 to 45 with stable bipolar disorder in remission and cognitive impairment.

Not a fit: Patients with severe physical illnesses, neurological diseases, or a history of seizures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cognitive function in patients with bipolar disorder.

How similar studies have performed: While the use of rTMS has been explored in various contexts, this specific application in bipolar disorder and cognitive function is relatively novel.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Shaohua Hu

Conditions Bipolar Disorder