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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
China Rehabilitation Research Center
RECRUITING
Beijing
Contact Information
Primary
Kaiyue Han, MD
hankaiyue1026@163.com
(86)13280010993
Backup
Ying Zhou
zhouying@cpl.ac.cn
010-80726688
Time Frame
Start Date: 2023-08-18
Estimated Completion Date: 2025-10
Participants
Target number of participants: 60
Treatments
Active_comparator: active iTBS group
active iTBS coupled with conventional cognitive therapy
Sham_comparator: sham iTBS group
sham iTBS coupled with conventional cognitive therapy
Related Therapeutic Areas
Sponsors
Leads: Changping Laboratory
Collaborators: China Rehabilitation Research Center

This content was sourced from clinicaltrials.gov