NCT05953415Completed
pBFS-guided iTBS Over the Left DLPFC for Chronic PSCI
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 12 Jul 2023
- Start date
- 18 Aug 2023
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Changping Laboratory
- Diseases
- Stroke
- NCT number
- NCT05953415
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 18 Aug 2023 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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 a history of seizures;
- be with contraindications to TMS treatment, such as having an implanted electronic device (e.g. cardiac pacemaker, cochlear implant);
Other
- 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 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.
Who the study is looking for
- 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.
Age in the registry: 35 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Rehabilitation Research Center Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.