pBFS-guided iTBS Over the Left DLPFC for Chronic PSCI

Launched by CHANGPING LABORATORY · Jul 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called intermittent theta burst stimulation (iTBS) to help improve cognitive abilities in people who have experienced a stroke and now have ongoing difficulties with thinking and memory. The treatment is guided by a technique that looks at how the brain is functioning, aiming to personalize the approach for each patient. The researchers want to find out if this method is safe and effective for those struggling with cognitive impairment after a stroke.

To be eligible for the trial, participants need to have had their first stroke at least 3 months but less than a year ago, and it should have affected specific areas of the brain. They should also show some difficulties in areas like memory or attention but not have other causes of cognitive impairment, such as Alzheimer’s disease. Participants will receive the treatment as part of the study and will be monitored closely for any effects. It’s important to note that people with certain medical conditions or those who have had specific treatments recently may not qualify for the study.

Gender

ALL

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.