Clinical trial NCT05953415: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Cognitive Impairment
Lead sponsor: Changping Laboratory
Sponsor class: OTHER
Collaborators: name: China Rehabilitation Research Center
First posted: 2023-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 weekdays, over a period of 3 weeks, totaling 15 treatment days.

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.

Primary outcomes:
measure: change in the Montreal cognitive assessment (MoCA)
timeFrame: baseline, end of the 3-week therapy
Secondary outcomes:
measure: change in the Montreal cognitive assessment (MoCA)
timeFrame: baseline, 3 months post-treatment
measure: change in the Mini-mental state examination(MMSE)
timeFrame: baseline, end of the 3-week therapy, 3 months post-treatment
measure: change in the Rivermead Behavioural Memory Test (RBMT )
timeFrame: baseline, end of the 3-week therapy
measure: change in the Stroop color word test (SCWT)
timeFrame: baseline, end of the 3-week therapy
measure: change in the Symbol Digit Modalities Test (SDMT)
timeFrame: baseline, end of the 3-week therapy
measure: change in the Digit Span Test (DST)
timeFrame: baseline, end of the 3-week therapy
measure: change in the Trail Making Test A and B (TMT A&B)
timeFrame: baseline, end of the 3-week therapy
measure: change in the Clock Drawing Test (CDT)
timeFrame: baseline, end of the 3-week therapy
measure: change in the Boston Naming Test (BNT)
timeFrame: baseline, end of the 3-week therapy
measure: change in the Modified barthel index (MBI)
timeFrame: baseline, end of the 3-week therapy, 3 months post-treatment
measure: change in the Hamilton Depression Scale (HAMD)
timeFrame: baseline, end of the 3-week therapy
measure: change in the Hamilton Anxiety Scale (HAMA)
timeFrame: baseline, end of the 3-week therapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Rehabilitation Research Center
Study officials:
affiliation: China Rehabilitation Research Center
name: Hao Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: