Chronic StrokeNCT05953415
pBFS-guided iTBS Over the Left DLPFC for Chronic PSCI
A study testing active iTBS in people with Chronic Stroke and Cognitive Impairment, run by Changping Laboratory at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Stroke, Cognitive Impairment
- What is being tested?
- active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2023to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 unilateral 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.
Who cannot join
- 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；
Show all 14Show fewer
- 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 having an implanted electronic device (e.g. cardiac pacemaker, cochlear implant);
- be with contraindications to MRI, such as the presence of ferromagnetic metallic implants or claustrophobia;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 at least 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 workdays, over a period of 3 weeks, totaling 15 treatment days.
- Conditions
- Chronic Stroke, Cognitive Impairment
- Being tested
- active iTBS, sham iTBS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active iTBSDevice
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.
sham iTBSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| active iTBS group | Active comparator | active iTBS coupled with conventional cognitive therapy Receives: Device: active iTBS |
| sham iTBS group | Sham comparator | sham iTBS coupled with conventional cognitive therapy Receives: Device: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, end of the 3-week therapy
Secondary outcomes (12)
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.
Measured: baseline, 3 months post-treatment
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.
Measured: baseline, end of the 3-week therapy, 3 months post-treatment
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy, 3 months post-treatment
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.
Measured: baseline, end of the 3-week therapy
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.
Measured: baseline, end of the 3-week therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start18 Aug 2023
- Primary completion1 Nov 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- China Rehabilitation Research Center
- Responsible party
- Sponsor
- Investigators
- Hao Zhang, PhD, Principal investigator, China Rehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953415
- Sponsor's protocol ID
- PSCI2023CRRC
- Status last verified
- Jun 2026
- First submitted
- 12 Jul 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data that support the findings of this study are available upon reasonable request.
Publications
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.
PubMed 41397743
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05953415
- Acronym / sponsor ID
- PSCI2023CRRC
- Conditions
- Chronic Stroke, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- China Rehabilitation Research Center
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 at least 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 workdays, over a period of 3 weeks, totaling 15 treatment days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active iTBS group | Active comparator | Device: active iTBSactive iTBS coupled with conventional cognitive therapy |
| sham iTBS group | Sham comparator | Device: sham iTBSsham iTBS coupled with conventional cognitive therapy |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 unilateral supratentorial region;
Key exclusion criteria (14 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active iTBSParticipants 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. | Device | active iTBS group |
| sham iTBSParticipants 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. | Device | sham iTBS group |
Primary outcome
change in the Montreal cognitive assessment (MoCA)
Time frame: baseline, end of the 3-week therapy
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.
12 secondary outcomes
change in the Montreal cognitive assessment (MoCA)
Time frame: baseline, 3 months post-treatment
change in the Mini-mental state examination(MMSE)
Time frame: baseline, end of the 3-week therapy, 3 months post-treatment
change in the Rivermead Behavioural Memory Test (RBMT )
Time frame: baseline, end of the 3-week therapy
change in the Stroop color word test (SCWT)
Time frame: baseline, end of the 3-week therapy
change in the Symbol Digit Modalities Test (SDMT)
Time frame: baseline, end of the 3-week therapy
change in the Digit Span Test (DST)
Time frame: baseline, end of the 3-week therapy
change in the Trail Making Test A and B (TMT A&B)
Time frame: baseline, end of the 3-week therapy
change in the Clock Drawing Test (CDT)
Time frame: baseline, end of the 3-week therapy
change in the Boston Naming Test (BNT)
Time frame: baseline, end of the 3-week therapy
change in the Modified barthel index (MBI)
Time frame: baseline, end of the 3-week therapy, 3 months post-treatment
change in the Hamilton Depression Scale (HAMD)
Time frame: baseline, end of the 3-week therapy
change in the Hamilton Anxiety Scale (HAMA)
Time frame: baseline, end of the 3-week therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 41397743Han 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.
- Individual participant dataSharing planned: Yes. Deidentified participant data that support the findings of this study are available upon reasonable request.
Related trials for Chronic Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic Stroke
Not yet recruiting
Effects of Jaw Clenching on Gait and Mobility in Stroke
Stroke
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Zhang, PhD principal investigator
China Rehabilitation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS in people with Chronic Stroke and Cognitive Impairment, run by Changping Laboratory at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in the Montreal cognitive assessment (MoCA) (time frame: baseline, end of the 3-week therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.