Stroke, IschemicNCT05907031
pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke
A study testing active continuous Theta Burst Stimulation in people with Stroke, Ischemic and Aphasia, run by Changping Laboratory at 1 site in China.
Trial summary
The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Ischemic, Aphasia
- What is being tested?
- active continuous Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2023to 30 Dec 2025
- 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
- Patients between the ages of 35 and 75 years (including 35 and 75 years).
- Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association 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 and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months .
- Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8.
- First onset stroke.
- Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education).
- Understand the trial and be able to provide informed consent.
Who cannot join
- Combined severe dysarthria (NIHSS item 10 score ≥ 2 points);
- Aphasia caused by bilateral hemispheric stroke, brain tumors, 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;
- Patients with severe systemic diseases such as heart, lung, liver, kidney diseases, etc., which cannot be controlled by routine medications as confirmed by laboratory tests and examinations;
- Impaired consciousness (NIHSS item 1(a) score ≥ 1 point);
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- Malignant hypertension;
- Malignant tumor;
- Patients with a life expectancy of less than 1 year due to reasons other than stroke;
- Severe hearing, visual, or cognitive impairments that prevent the patient from completing the trial;
- Patients with severe depression, anxiety, or other mental illnesses that prevent them from completing the trial;
- Patients who have received other neuroregulatory treatments such as TMS or transcranial electrical stimulation within 3 months before enrollment;
- History of alcohol abuse, drug abuse, or other substance abuse;
- Patients with other abnormal test results that make them unsuitable for participating in this trial as determined by the researchers;
- Women of childbearing age who are pregnant or planning to become pregnant;
- Patients participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Jun Yu
About this study
Official title: Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy Targeting at the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT
The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.
Read the detailed description
Increasing evidence suggests that rTMS has been effective in treating various psychological and neurological diseases, including treating post-stroke symptoms. Using the personalized brain functional sectors (pBFS) technique, investigators could precisely identify individualized brain functional networks and the personalized language-related stimulation site based on the resting-state functional MRI data. The current study proposes to conduct a double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized rTMS intervention in post-stroke aphasic patients.
Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS) group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol consisted of a 3-week treatment, with five consecutive days each week (totally 15 day-treatment) . The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.
- Conditions
- Stroke, Ischemic, Aphasia
- Being tested
- active continuous Theta Burst Stimulation, sham continuous Theta Burst Stimulation
- Medical subject headings
- Ischemic Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active continuous Theta Burst StimulationDevice
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 days each week.
sham continuous Theta Burst StimulationDevice
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 days each week.
| Study group | Role | What they receive |
|---|---|---|
| active cTBS group | Active comparator | active cTBS combined with speech language therapy Receives: Device: active continuous Theta Burst Stimulation |
| sham cTBS group | Sham comparator | sham cTBS combined with speech language therapy Receives: Device: sham continuous Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 into an Aphasia Quotient, lower scores indicate worse outcomes.
Measured: baseline, end of the 3-week therapy
Secondary outcomes (3)
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 into an Aphasia Quotient, lower scores indicate worse outcomes.
Measured: baseline, end of the 5-day therapy, end of the follow-up of 3 weeks
Boston Diagnostic Aphasia Examination Severity Ratings
The Boston Diagnostic Aphasia Examination (BDAE) Severity Ratings is a clinical tool used to evaluate the severity and type of aphasia in individuals. The assessment includes four domains: communication abilities, language content, speech sound production and response abilities. BDAE severity ratings range from level 1 to level 5, with lower scores indicating more severe aphasia.
Measured: baseline，end of the 3-week therapy，end of the follow-up of 3 weeks
Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
The SAQOL-39g is a quality of life assessment tool that is used to evaluate the impact of stroke and aphasia on a patient's quality of life. It consists of 39 items that cover a range of domains related to the patient's quality of life, such as communication, physical functioning, mood, and social support. The items are rated on a 5-point Likert scale ranging from "not at all" to "very much", with higher scores indicating better quality of life.
Measured: baseline，end of the 3-week therapy，end of the follow-up of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start23 Aug 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, PhD, Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907031
- Sponsor's protocol ID
- CPSA02FJ30
- Status last verified
- Sep 2024
- First submitted
- 8 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy Targeting at the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT
- ClinicalTrials.gov ID
- NCT05907031
- Acronym / sponsor ID
- CPSA02FJ30
- Conditions
- Stroke, Ischemic, Aphasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Fujian Medical University
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Jun 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 objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.
Detailed description
Increasing evidence suggests that rTMS has been effective in treating various psychological and neurological diseases, including treating post-stroke symptoms. Using the personalized brain functional sectors (pBFS) technique, investigators could precisely identify individualized brain functional networks and the personalized language-related stimulation site based on the resting-state functional MRI data. The current study proposes to conduct a double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized rTMS intervention in post-stroke aphasic patients.
Subjects will be randomly assigned to the following two groups: active continuous TBS (cTBS) group, or a sham control group. The allocation ratio will be 1:1. The stimulation protocol consisted of a 3-week treatment, with five consecutive days each week (totally 15 day-treatment) . The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.
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 cTBS group | Active comparator | Device: active continuous Theta Burst Stimulationactive cTBS combined with speech language therapy |
| sham cTBS group | Sham comparator | Device: sham continuous Theta Burst Stimulationsham cTBS combined with speech language therapy |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients between the ages of 35 and 75 years (including 35 and 75 years).
- Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association 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 and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months .
- Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8.
- First onset stroke.
- Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education).
Key exclusion criteria (16 listed)
- Combined severe dysarthria (NIHSS item 10 score ≥ 2 points);
- Aphasia caused by bilateral hemispheric stroke, brain tumors, 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;
- Patients with severe systemic diseases such as heart, lung, liver, kidney diseases, etc., which cannot be controlled by routine medications as confirmed by laboratory tests and examinations;
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 continuous Theta Burst StimulationEach 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 days each week. | Device | active cTBS group |
| sham continuous Theta Burst StimulationEach 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 days each week. | Device | sham cTBS group |
Primary outcome
Change in the Western Aphasia Battery scores
Time frame: baseline, end of the 3-week therapy
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 into an Aphasia Quotient, lower scores indicate worse outcomes.
3 secondary outcomes
Change in the Western Aphasia Battery scores
Time frame: baseline, end of the 5-day therapy, end of the follow-up of 3 weeks
Boston Diagnostic Aphasia Examination Severity Ratings
Time frame: baseline，end of the 3-week therapy，end of the follow-up of 3 weeks
Chinese-version Stroke and Aphasia Quality of Life Scale 39-generic version (SAQOL-39g)
Time frame: baseline，end of the 3-week therapy，end of the follow-up of 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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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.
Hesheng Liu, PhD study chair
Changping Laboratory
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 continuous Theta Burst Stimulation in people with Stroke, Ischemic and Aphasia, 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 4 Apr 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianting Huang, MD,PhD (010-80726688, jianting.huang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Western Aphasia Battery scores (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?
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 4 Apr 2025.