pBFS-guided cTBS at Different Doses for Aphasia After Stroke
Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy at Different Doses for Aphasia After Stroke: a RCT
1 other identifier
interventional
60
1 country
2
Brief Summary
The objective of this trial is to evaluate the effectiveness and safeness of different doses of continuous Theta Burst Stimulation (cTBS) over the right Superior Frontal Gyrus (SFG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-stroke aphasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Sep 2023
Typical duration for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2025
CompletedApril 4, 2025
September 1, 2024
2 years
July 23, 2023
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the Western Aphasia Battery scores
The first four subsets of the WAB (Spontaneous Speech, Auditory verbal comprehension, Repetition, Naming and word finding) will be used to evaluate the participants' language ability impairments. A Chinese adapted version of WAB will be used. The scores from all four subsets will be calculated as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
baseline, end of the 3-week therapy
Secondary Outcomes (3)
Change in the Western Aphasia Battery scores
baseline, end of the 5-day therapy, 90 days after treatment initiation
Boston Diagnostic Aphasia Examination Severity Ratings
baseline，end of the 3-week therapy，90 days after treatment initiation
Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
baseline，end of the 3-week therapy，90 days after treatment initiation
Study Arms (6)
active 1200-pulse cTBS group
ACTIVE COMPARATORactive 1200-pulse cTBS combined with speech language therapy
active 2400-pulse cTBS group
ACTIVE COMPARATORactive 2400-pulse cTBS combined with speech language therapy
active 3600-pulse cTBS group
ACTIVE COMPARATORactive 3600-pulse cTBS combined with speech language therapy
sham 1200-pulse cTBS group
SHAM COMPARATORsham 1200-pulse cTBS combined with speech language therapy
sham 2400-pulse cTBS group
SHAM COMPARATORsham 2400-pulse cTBS combined with speech language therapy
sham 3600-pulse cTBS group
SHAM COMPARATORsham 3600-pulse cTBS combined with speech language therapy
Interventions
Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
Each patient will receive two 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
Each patient will receive two 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
Each patient will receive two sham 1200-pulse cTBS stimulations per day, parted by a 30-minute rest period (a total of 2400 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
Each patient will receive two sham 1800-pulse cTBS stimulations per day, parted by a 50-minute rest period (a total of 3600 pulses daily), for 3-week treatment, with 5 consecutive workdays each week.
Eligibility Criteria
You may qualify if:
- The patient's age ranges from 35 to 75 years old (including 35 and 75 years old);
- Meet the diagnostic criteria for ischemic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2019 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2018) or meet the diagnostic criteria for hemorrhagic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2022 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2019) ，with lesions located in the left hemisphere, and a duration of illness ranging from 15 days to 6 months.
- Diagnosed as aphasia patient according to the Chinese version of Western Aphasia Battery (WAB), with a WAB-aphasia quotient of less than 93.8 points;
- First onset of stroke;
- Normal language function before the onset of stroke, and the patient's native language is Chinese with at least 6 years of education;
- Understand the trial and signed the informed consent form.
You may not qualify if:
- Combined dysarthria (NIHSS item 10 score ≥2 points);
- Aphasia caused by bilateral hemisphere stroke, brain tumor, traumatic brain injury, Parkinson's disease, motor neuron disease, or other diseases；
- Patients with implanted electronic devices such as cardiac pacemakers, cochlear implants, or other metal foreign bodies, or those with MRI contraindications such as claustrophobia or TMS treatment contraindications;
- History of epilepsy;
- Patient with concomitant severe systemic diseases affecting the heart, lungs, liver, kidneys, etc., and uncontrolled by conventional medication, as detected and confirmed through laboratory testing and examination;
- Patients with consciousness disorders (NIHSS 1(a) score ≥1);
- Patients with malignant hypertension;
- Patients with severe organic diseases, such as malignant tumors, with an expected survival time of less than 1 year;
- Patients with severe hearing, visual, cognitive impairment or inability to cooperate with the trial;
- Patients with severe depression, anxiety, or diagnosed with other mental illnesses that prevent them from completing the trial;
- Patients who have received other neuromodulation treatments such as TMS, transcranial electric stimulation, etc. in the 3 months prior to enrollment;
- Patients with a history of alcoholism, drug abuse, or other substance abuse;
- Patients with other abnormal findings that the researchers judge are not suitable for participation in this trial;
- Patients who are unable to complete follow-up due to geographical or other reasons;
- Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nanshi Hospital of Nanyang
Nanyang, Henan, China
The fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hesheng Liu, PhD
Changping Laboratory
Central Study Contacts
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 23, 2023
First Posted
August 1, 2023
Study Start
September 22, 2023
Primary Completion
September 22, 2025
Study Completion
December 22, 2025
Last Updated
April 4, 2025
Record last verified: 2024-09