A Randomized Controlled Study on the Efficacy and Safety of Task-activated rTMS in Improving Cognitive Function in Patients With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- PDQ-21
研究概览
简要总结
- To clarify the efficacy and safety of task-based repetitive transcranial magnetic stimulation (rTMS) on cognitive function in patients with stable bipolar disorder.
- To analyze the therapeutic mechanism of transcranial magnetic stimulation based on magnetic resonance imaging and explore the abnormal regulation mechanism of cognitive neural circuits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Repetitive transcranial magnetic stimulation device (Device)
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
干预措施: Repetitive transcranial magnetic stimulation device (Device)
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
干预措施: Repetitive transcranial magnetic stimulation device (Device)
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
干预措施: Repetitive transcranial magnetic stimulation device (Device)
结局指标
主要结局
PDQ-21
时间窗: 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.
次要结局
- brain imaging (MRI)(0-5 days)