Back to resultspBFS-guided iTBS Over the Left DLPFC for Chronic PSCI
Primary Purpose
Chronic Stroke, Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
active iTBS
sham iTBS
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stroke
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.
Sites / Locations
- China Rehabilitation Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active iTBS group
sham iTBS group
Arm Description
active iTBS coupled with conventional cognitive therapy
sham iTBS coupled with conventional cognitive therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
change in the Mini-mental state examination(MMSE)
The Mini-Mental State Examination (MMSE) is a widely employed neuropsychological test for evaluating cognitive decline. It comprises 11 items that assess five key domains: orientation, memory, attention and calculation, recall, and language abilities. The total score on the MMSE is 30, with higher scores indicating better cognitive function.
change in the Rivermead Behavioural Memory Test (RBMT )
The Rivermead Behavioral Memory Test (RBMT) is a tool utilized to evaluate individuals' daily memory capabilities, encompassing immediate memory, delayed recall, visual memory, and anticipatory memory. A total score of 24 is allocated, with lower scores indicating decreased memory performance.
change in the Stroop color word test (SCWT)
The Stroop Color Word Test (SCWT) is employed to evaluate selective attention, cognitive flexibility, and processing speed. The test comprises three components. Higher scores and shorter completion times on the SCWT indicate better performance and outcomes.
change in the Symbol Digit Modalities Test (SDMT)
The Symbol Digit Modalities Test (SDMT) is a neuropsychological assessment that measures attention, processing speed, and cognitive flexibility. During the SDMT, participants are tasked with converting symbols into their corresponding numbers within a given time limit, using a symbol-digit control chart as reference. Higher completion rates on the SDMT indicate better performance and outcomes in the test.
change in the Digit Span Test (DST)
The Digit Span Test (DST) is a neuropsychological assessment used to evaluate short-term memory and working memory. During the DST, participants are presented with a series of digits and are required to recall them in the same order as presented. The test consists of two parts: digit forward recall and digit backward recall. A higher number of correctly recalled digits indicates a better performance and outcome on the test.
change in the Trail Making Test A and B (TMT A&B)
The Trail Making Test (TMT) is a cognitive assessment tool that evaluates cognitive flexibility, executive function, and attention. During the TMT, participants are instructed to connect a series of numbers and letters in sequential order as quickly as possible. Test results are measured by the time taken to complete the test and the number of correct connections made. Higher numbers of correct connections and shorter completion times indicate better performance and outcomes on the test.
change in the Clock Drawing Test (CDT)
The Clock-Drawing Test (CDT) is a straightforward and effective cognitive assessment tool employed to evaluate executive function and visual-spatial abilities. The test involves drawing a clock face and setting the hands to a specified time. The total score on the CDT is 4, with higher scores indicating superior outcomes.
change in the Boston Naming Test (BNT)
The Boston Naming Test (BNT) is a frequently employed neuropsychological assessment utilized to evaluate language and memory abilities. During the BNT, participants are presented with a series of images and are required to provide the corresponding names for each image. The test comprises 30 questions, and a higher number of correct responses indicates better performance and outcomes.
change in the Modified barthel index (MBI)
The Modified Barthel Index (MBI) is employed to evaluate an individual's ability to perform activities of daily living. It encompasses 10 items: eating, bathing, grooming, dressing, bowel control, bladder control, toileting, transferring, walking, and navigating stairs. The total score on the MBI is 100, with higher scores indicating better functional outcomes.
change in the Hamilton Depression Scale (HAMD)
The Hamilton Depression Scale (17-item scale) (HAMD) is a tool utilized to evaluate the severity of depression. It provides a maximum total score of 52, with higher scores indicating more severe symptoms of depression. The score ranges for the HAMD (17-item scale) are typically categorized as follows: 0-7: normal or no depressive symptoms; 8-16: mild depression; 17-23: moderate depression; 24-30: moderate to severe depression; 31 and above: severe depression.
change in the Hamilton Anxiety Scale (HAMA)
The Hamilton Anxiety Scale (HAMA) is utilized to evaluate the severity of anxiety disorders. It provides a maximum total score of 56 points, with higher scores indicating more severe anxiety symptoms.
Full Information
NCT ID
NCT05953415
First Posted
July 12, 2023
Last Updated
September 20, 2023
Sponsor
Changping Laboratory
Collaborators
China Rehabilitation Research Center
1. Study Identification
Unique Protocol Identification Number
NCT05953415
Brief Title
pBFS-guided iTBS Over the Left DLPFC for Chronic PSCI
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changping Laboratory
Collaborators
China Rehabilitation Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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 a 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 weekdays, over a period of 3 weeks, totaling 15 treatment days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke, Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active iTBS group
Arm Type
Active Comparator
Arm Description
active iTBS coupled with conventional cognitive therapy
Arm Title
sham iTBS group
Arm Type
Sham Comparator
Arm Description
sham iTBS coupled with conventional cognitive therapy
Intervention Type
Device
Intervention Name(s)
active iTBS
Intervention Description
Participants in this group will receive two sessions of 1800-pulse active stimulation per day, with an intersession interval of 50 minutes. The stimulation will be administered on workdays over a period of 3 weeks, totaling 15 days.
Intervention Type
Device
Intervention Name(s)
sham iTBS
Intervention Description
Participants in this group will receive two sessions of 1800-pulse sham stimulation per day, with an intersession interval of 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.
Primary Outcome Measure Information:
Title
change in the Montreal cognitive assessment (MoCA)
Description
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.
Time Frame
baseline, end of the 3-week therapy
Secondary Outcome Measure Information:
Title
change in the Montreal cognitive assessment (MoCA)
Description
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.
Time Frame
baseline, 3 months post-treatment
Title
change in the Mini-mental state examination(MMSE)
Description
The Mini-Mental State Examination (MMSE) is a widely employed neuropsychological test for evaluating cognitive decline. It comprises 11 items that assess five key domains: orientation, memory, attention and calculation, recall, and language abilities. The total score on the MMSE is 30, with higher scores indicating better cognitive function.
Time Frame
baseline, end of the 3-week therapy, 3 months post-treatment
Title
change in the Rivermead Behavioural Memory Test (RBMT )
Description
The Rivermead Behavioral Memory Test (RBMT) is a tool utilized to evaluate individuals' daily memory capabilities, encompassing immediate memory, delayed recall, visual memory, and anticipatory memory. A total score of 24 is allocated, with lower scores indicating decreased memory performance.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Stroop color word test (SCWT)
Description
The Stroop Color Word Test (SCWT) is employed to evaluate selective attention, cognitive flexibility, and processing speed. The test comprises three components. Higher scores and shorter completion times on the SCWT indicate better performance and outcomes.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Symbol Digit Modalities Test (SDMT)
Description
The Symbol Digit Modalities Test (SDMT) is a neuropsychological assessment that measures attention, processing speed, and cognitive flexibility. During the SDMT, participants are tasked with converting symbols into their corresponding numbers within a given time limit, using a symbol-digit control chart as reference. Higher completion rates on the SDMT indicate better performance and outcomes in the test.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Digit Span Test (DST)
Description
The Digit Span Test (DST) is a neuropsychological assessment used to evaluate short-term memory and working memory. During the DST, participants are presented with a series of digits and are required to recall them in the same order as presented. The test consists of two parts: digit forward recall and digit backward recall. A higher number of correctly recalled digits indicates a better performance and outcome on the test.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Trail Making Test A and B (TMT A&B)
Description
The Trail Making Test (TMT) is a cognitive assessment tool that evaluates cognitive flexibility, executive function, and attention. During the TMT, participants are instructed to connect a series of numbers and letters in sequential order as quickly as possible. Test results are measured by the time taken to complete the test and the number of correct connections made. Higher numbers of correct connections and shorter completion times indicate better performance and outcomes on the test.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Clock Drawing Test (CDT)
Description
The Clock-Drawing Test (CDT) is a straightforward and effective cognitive assessment tool employed to evaluate executive function and visual-spatial abilities. The test involves drawing a clock face and setting the hands to a specified time. The total score on the CDT is 4, with higher scores indicating superior outcomes.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Boston Naming Test (BNT)
Description
The Boston Naming Test (BNT) is a frequently employed neuropsychological assessment utilized to evaluate language and memory abilities. During the BNT, participants are presented with a series of images and are required to provide the corresponding names for each image. The test comprises 30 questions, and a higher number of correct responses indicates better performance and outcomes.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Modified barthel index (MBI)
Description
The Modified Barthel Index (MBI) is employed to evaluate an individual's ability to perform activities of daily living. It encompasses 10 items: eating, bathing, grooming, dressing, bowel control, bladder control, toileting, transferring, walking, and navigating stairs. The total score on the MBI is 100, with higher scores indicating better functional outcomes.
Time Frame
baseline, end of the 3-week therapy, 3 months post-treatment
Title
change in the Hamilton Depression Scale (HAMD)
Description
The Hamilton Depression Scale (17-item scale) (HAMD) is a tool utilized to evaluate the severity of depression. It provides a maximum total score of 52, with higher scores indicating more severe symptoms of depression. The score ranges for the HAMD (17-item scale) are typically categorized as follows: 0-7: normal or no depressive symptoms; 8-16: mild depression; 17-23: moderate depression; 24-30: moderate to severe depression; 31 and above: severe depression.
Time Frame
baseline, end of the 3-week therapy
Title
change in the Hamilton Anxiety Scale (HAMA)
Description
The Hamilton Anxiety Scale (HAMA) is utilized to evaluate the severity of anxiety disorders. It provides a maximum total score of 56 points, with higher scores indicating more severe anxiety symptoms.
Time Frame
baseline, end of the 3-week therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaiyue Han, MD
Phone
(86)13280010993
Email
hankaiyue1026@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Zhou
Phone
010-80726688
Email
zhouying@cpl.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Zhang, PhD
Organizational Affiliation
China Rehabilitation Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Rehabilitation Research Center
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Zhang, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
pBFS-guided iTBS Over the Left DLPFC for Chronic PSCI
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