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Completed

NCT Number: NCT06782763

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.

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Key information

Age range

14 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Repetitive transcranial magnetic stimulation device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. brain imaging (MRI)

    Time frame: 0-5 days

    Functional and structural changes in brain imaging (MRI)

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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