Personalized Brain Functional Sectors (pBFS) Guided Intermittent Theta-Burst Stimulation (iTBS) Therapy for Chronic Post-Stroke Cognitive Impairment (PSCI): A Randomized, Double-Blind, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change in the Montreal cognitive assessment (MoCA)
研究概览
简要总结
The study aims to investigate the efficacy and safety of intermittent theta burst stimulation (iTBS) guided by the personalized Brain Functional Sector (pBFS) technique in the treatment of patients with chronic post-stroke cognitive impairment.
详细描述
Cognitive impairment, characterized by memory loss, attention and executive functional impairment, is a common complication following stroke. Intermittent Theta Burst Stimulation (iTBS) is a non-invasive neuromodulation technique that applies pulsed magnetic fields to the cerebral cortex, inducing changes in local or distal neural activity and promoting cognitive function. By employing the personalized Brain Functional Segmentation (pBFS) technique, individualized brain functional networks can be precisely identified based on resting-state functional MRI scans. Within the executive function network, a specific region of the dorsolateral prefrontal cortex (DLPFC) will be selected as the intervention target.
Participants will be randomly assigned to two groups at 1:1 ratio: the active group and the sham group. The stimulation will be administered using a figure-of-8 coil with the assist of a real-time neuronavigation system. Two sessions of 1800 pulses will be applied, totaling 3600 pulses per day, with at least 50-minute interval period between sessions for both groups. The sham stimulation will be administered using a sham coil that mimics the sound and appearance of the active stimulation coil but does not deliver actual stimulation. The intervention will be administered on workdays, over a period of 3 weeks, totaling 15 treatment days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be meet the diagnostic criteria of "Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke","2018 Chinese guidelines for diagnosis and treatment of acute ischemic stroke" for the diagnosis of ischemic stroke, and "2022 Guideline for the Management of Patients With Spontaneous Intracerebral Hemorrhage: A Guideline From the American Heart Association/American Stroke Association", "2019 Chinese guidelines for diagnosis and treatment of acuteintracerebral hemorrhage" for the diagnosis of hemorrhagic stroke and was confirmed by CT or MRI;
- •meet the PSCI diagnostic criteria of "2021 Experts Consensus on Post-stroke Cognitive lmpairment Management";
- •be their first stroke;
- •have a stroke duration of 3-12 month;
- •have the stroke located in the unilateral supratentorial region;
- •be meet at least one of the following conditions: 1) dysfunction in at least one of the five domains: executive function, attention, memory, language ability, and visuospatial ability; 2) mild to moderate cognitive impairment: MMSE ≥ 10, and MoCA < 26 or MMSE < 27;
- •understand the trial and be able to provide informed consent.
排除标准
- •Have been diagnosed with cognitive impairment resulting from other disorders including mild cognitive impairment (MCI), Alzheimer's disease (AD), vascular dementia (VCI), acquired traumatic brain injury (TBI);
- •have history of drug or alcohol abuse;
- •have history of other psychiatric disorders or currently experiencing severe depression or anxiety (HAMD-17 > 24 or HAMA ≥ 29);
- •be with severe primary diseases in the circulatory, respiratory, digestive, urinary, endocrine, or hematopoietic systems that cannot be controlled by conventional medications;
- •be with malignant hypertension or malignant tumors；
- •be with severe infections, water and electrolyte imbalances, or acid-base disturbances；
- •be with severe aphasia (NIHSS_language ≥ 2 points), dysarthria (NIHSS_dysarthria ≥ 2 points), impaired consciousness (NIHSS_level of consciousness ≥ 1 point), audiovisual impairments, or those unable to cooperate with the assessment or treatment；
- •be with a history of seizures;
- •be with contraindications to TMS treatment, such as having an implanted electronic device (e.g. cardiac pacemaker, cochlear implant);
- •be with contraindications to MRI, such as the presence of ferromagnetic metallic implants or claustrophobia;
- •have received neuromodulation therapy such as TMS, transcranial electrical stimulation, or transcranial focused ultrasound within the past 3 months prior to enrollment;
- •be concurrently participating in other clinical trials;
- •be pregnant women or those planning to become pregnant;
- •be with other abnormalities as determined by the investigator that do not meet the trial criteria.
研究组 & 干预措施
active iTBS group
active iTBS coupled with conventional cognitive therapy
干预措施: active iTBS (Device)
sham iTBS group
sham iTBS coupled with conventional cognitive therapy
干预措施: sham iTBS (Device)
结局指标
主要结局
change in the Montreal cognitive assessment (MoCA)
时间窗: baseline, end of the 3-week therapy
The Montreal Cognitive Assessment (MoCA) is a rapid screening tool used to assess mild cognitive impairment (MCI). It evaluates cognitive function across seven domains, including visuo-spatial and executive function, naming, memory, attention, language, abstraction, and delayed recall. The total score on the MoCA is 30, with higher scores indicating better cognitive function.
次要结局
- change in the Digit Span Test (DST)(baseline, end of the 3-week therapy)
- change in the Clock Drawing Test (CDT)(baseline, end of the 3-week therapy)
- change in the Modified barthel index (MBI)(baseline, end of the 3-week therapy, 3 months post-treatment)
- change in the Hamilton Depression Scale (HAMD)(baseline, end of the 3-week therapy)
- change in the Montreal cognitive assessment (MoCA)(baseline, 3 months post-treatment)
- change in the Mini-mental state examination(MMSE)(baseline, end of the 3-week therapy, 3 months post-treatment)
- change in the Symbol Digit Modalities Test (SDMT)(baseline, end of the 3-week therapy)
- change in the Rivermead Behavioural Memory Test (RBMT )(baseline, end of the 3-week therapy)
- change in the Stroop color word test (SCWT)(baseline, end of the 3-week therapy)
- change in the Boston Naming Test (BNT)(baseline, end of the 3-week therapy)
- change in the Trail Making Test A and B (TMT A&B)(baseline, end of the 3-week therapy)
- change in the Hamilton Anxiety Scale (HAMA)(baseline, end of the 3-week therapy)