Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder
A Randomized Controlled Study on the Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder
1 other identifier
interventional
82
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2024
CompletedFirst Submitted
Initial submission to the registry
January 1, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedFebruary 11, 2025
December 1, 2024
6 months
January 1, 2025
February 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
PDQ-21
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 Outcomes (1)
brain imaging (MRI)
0-5 days
Study Arms (4)
rTMS active group and active cognitive training
EXPERIMENTALReceive 10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of cognitive training at the same time
rTMS active group and sham cognitive training
SHAM COMPARATOR10 Hz, 20 minutes of active rTMS stimulation; 20 minutes of perform simple judgment training at the same time
rTMS sham group and active cognitive training
SHAM COMPARATOR10 Hz, 20 minutes of low-intensity rTMS stimulation; 20 minutes of cognitive training at the same time
rTMS sham group and sham cognitive training
SHAM COMPARATOR10 Hz, 20 minutes of low-intensity rTMS stimulation; perform simple judgment training for 20 minutes at the same time
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2025
First Posted
January 20, 2025
Study Start
December 20, 2024
Primary Completion
June 30, 2025
Study Completion
September 1, 2025
Last Updated
February 11, 2025
Record last verified: 2024-12