StrokeNCT05957354
pBFS-guided Dual-target cTBS for Aphasia After Stroke
A study testing active continuous Theta Burst Stimulation in people with Stroke and Aphasia, run by Changping Laboratory at 2 sites in China.
Trial summary
The objective of this trial is to evaluate the effectiveness and safeness of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) for language function recovery in post-stroke aphasic… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- 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
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 28 Jul 2023to 1 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
- 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.
Who cannot join
- 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);
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- 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;
- Patients who are currently participating in other clinical trials.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Xiaohua Fan
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Pingping Meng
About this study
Official title: Personalized Brain Functional Sector-guided Dual-target Continuous Theta Burst Stimulation Therapy for Aphasia After Stroke: a RCT
The objective of this trial is to evaluate the effectiveness and safeness of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) for language function recovery in post-stroke aphasic patients.
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 dual-target 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 5 consecutive workdays each week (totally 15 day-treatment). The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.
- Being tested
- active continuous Theta Burst Stimulation, sham continuous Theta Burst Stimulation
- Medical subject headings
- 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 a combination of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.
sham continuous Theta Burst StimulationDevice
Each patient will receive a combination of stimulation sequences, including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays 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 as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
Measured: baseline, end of the 3-week therapy
Secondary outcomes (4)
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.
Measured: baseline, end of the 5-day therapy, 90 days after treatment initiation
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 0 to level 5, with lower scores indicating more severe aphasia.
Measured: baseline, end of the 3-week therapy，90 days after treatment initiation
Token test
The Token Test is a language assessment tool used to evaluate a person's ability to understand spoken language and follow instructions. Each correct response in each task is awarded one point, typically. Different point values may be assigned based on the complexity of the task. The total score is calculated by adding up the accumulated scores across all tasks. The total scores range from 0 to 36, with higher scores indicating better language abilities.
Measured: 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)
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，90 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start28 Jul 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 (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
- NCT05957354
- Sponsor's protocol ID
- CPSA05SD60
- Status last verified
- Aug 2024
- First submitted
- 14 Jul 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Dual-target Continuous Theta Burst Stimulation Therapy for Aphasia After Stroke: a RCT
- ClinicalTrials.gov ID
- NCT05957354
- Acronym / sponsor ID
- CPSA05SD60
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 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 objective of this trial is to evaluate the effectiveness and safeness of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) for language function recovery in post-stroke aphasic patients.
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 dual-target 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 5 consecutive workdays 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)
- 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;
Key exclusion criteria (16 listed)
- 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;
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 a combination of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week. | Device | active cTBS group |
| sham continuous Theta Burst StimulationEach patient will receive a combination of stimulation sequences, including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays 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 as an Aphasia Quotient (ranging from 0 to 100), with lower Aphasia Quotients indicating poorer language abilities.
4 secondary outcomes
Change in the Western Aphasia Battery scores
Time frame: baseline, end of the 5-day therapy, 90 days after treatment initiation
Boston Diagnostic Aphasia Examination Severity Ratings
Time frame: baseline, end of the 3-week therapy，90 days after treatment initiation
Token test
Time frame: 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)
Time frame: baseline，end of the 3-week therapy，90 days after treatment initiation
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.
- Individual participant dataSharing planned: No
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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
2 sites 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 and Aphasia, run by Changping Laboratory at 2 sites 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 2 sites 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 Ruiqi Pan (010-80726688, ruiqipanedu@163.com), 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.