pBFS-guided iTBS Over the Left DLPFC for Chronic PSCI

NCT05953415 | Recruiting

• 1 other identifier: PSCI2023CRRC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Stroke; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• change in the Montreal cognitive assessment (MoCA)

  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.

  baseline, end of the 3-week therapy

Secondary Outcomes (12)

• 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 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 Symbol Digit Modalities Test (SDMT)

  baseline, end of the 3-week therapy

Study Arms (2)

active iTBS group

ACTIVE COMPARATOR

active iTBS coupled with conventional cognitive therapy

Device: active iTBS

sham iTBS group

SHAM COMPARATOR

sham iTBS coupled with conventional cognitive therapy

Device: sham iTBS

Interventions

active iTBS DEVICE

Participants in this group will receive two sessions of 1800-pulse active stimulation per day, with an intersession interval of at least 50 minutes. The stimulation will be administered on workdays over a period of 3 weeks, totaling 15 days.

active iTBS group

sham iTBS DEVICE

Participants in this group will receive two sessions of 1800-pulse sham stimulation per day, with an intersession interval of at least 50 minutes. The stimulation will be comprehensively mimic the active condition, and also administered on workdays over a period of 3 weeks, totaling 15 days.

sham iTBS group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changping Laboratory: lead
• China Rehabilitation Research Center: collaborator

Study Sites (1)

China Rehabilitation Research Center

Beijing, China

RECRUITING

Related Publications (1)

• Han K, Zhou Y, Huang J, Ren J, Lu H, Liao X, Zhu Y, Zhang H, Liu H. High-dose intermittent theta burst stimulation targeting the individualised frontoparietal cognitive network for post-stroke cognitive impairment: protocol for a randomised sham-controlled trial in China. BMJ Open. 2025 Dec 14;15(12):e100792. doi: 10.1136/bmjopen-2025-100792.

  PMID: 41397743 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hao Zhang, PhD

  China Rehabilitation Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaiyue Han, MD

CONTACT

(86)13280010993; hankaiyue1026@163.com

Ying Zhou

CONTACT

010-80726688; zhouying@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: August 18, 2023
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

CN (1)