Using brain stimulation to improve cognitive function in chronic stroke patients

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

This study tests if a new type of brain stimulation can help improve thinking skills in people who have long-term cognitive issues after a stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Changping Laboratory (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05953415 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of intermittent theta burst stimulation (iTBS) guided by the personalized Brain Functional Sector (pBFS) technique for treating chronic post-stroke cognitive impairment. Participants will undergo non-invasive brain stimulation targeting the dorsolateral prefrontal cortex, identified through resting-state functional MRI scans. The study involves a randomized controlled design with two groups: one receiving active stimulation and the other receiving sham stimulation, administered over three weeks. The aim is to assess improvements in cognitive function following the intervention.

Who should consider this trial

Good fit: Ideal candidates are individuals who have experienced their first stroke 3-12 months prior and have been diagnosed with chronic post-stroke cognitive impairment.

Not a fit: Patients who have had multiple strokes or those with cognitive impairment due to other causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance cognitive function in patients suffering from chronic post-stroke cognitive impairment.

How similar studies have performed: Other studies utilizing non-invasive brain stimulation techniques have shown promise in improving cognitive function, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

* 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 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.

Exclusion Criteria:

* 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 those with cardiac pacemakers, cochlear implants, or other metallic foreign bodies or any implanted electronic devices;
* be with contraindications to MRI scanning;
* 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.

Where this trial is running

Beijing

• China Rehabilitation Research Center — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Hao Zhang, PhD — China Rehabilitation Research Center
• Study coordinator: Kaiyue Han, MD

Conditions Chronic Stroke; Cognitive Impairment