Stroke, IschemicNCT06086938
pBFS-guided cTBS Combined With iTBS Over the Superior Frontal Gyrus for Aphasia After Ischemic Stroke
A study testing active cTBS combined with iTBS in people with Stroke, Ischemic and Aphasia, run by Changping Laboratory.
Trial summary
The current study aims to evaluate the efficacy and safety of pBFS-guided cTBS combined with iTBS for the rehabilitation of language functions 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 cTBS combined with iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 20 Oct 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 acute ischemic stroke (diagnosed according to the "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" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, and a duration of ≥15 days and ≤3 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 functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school；
- Understand the trial and signed the informed consent form.
Who cannot join
- Combined severe 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 neuroregulatory 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
No sites are listed yet.
About this study
Official title: Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Combined With Intermittent Theta Burst Stimulation Therapy Targeting at the Superior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT
The current study aims to evaluate the efficacy and safety of pBFS-guided cTBS combined with iTBS for the rehabilitation of language functions 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, we 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 cTBS combined with iTBS intervention in post-stroke aphasic patients.
Subjects will be randomly assigned to the following two groups: active TBS（cTBS+iTBS）group, or a sham TBS（sham cTBS+sham iTBS）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 cTBS combined with iTBS, sham cTBS combined with iTBS
- 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 cTBS combined with iTBSDevice
Daily TBS treatment consists of the following combination: active 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + active 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + active 600-pulse cTBS applied to the SFG in the unaffected hemisphere + active 600-pulses iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of TBS intervention.
The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.
sham cTBS combined with iTBSDevice
Daily sham TBS treatment consists of the following combination: sham 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + sham 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + sham 600-pulse cTBS applied to the SFG in the unaffected hemisphere + 600-pulse sham iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of sham TBS intervention.
The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| active TBS group | Active comparator | active TBS combined with speech language therapy Receives: Device: active cTBS combined with iTBS |
| sham TBS group | Sham comparator | sham TBS combined with speech language therapy Receives: Device: sham cTBS combined with iTBS |
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 (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 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
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 posted17 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086938
- Sponsor's protocol ID
- CPSA07BJ40
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Combined With Intermittent Theta Burst Stimulation Therapy Targeting at the Superior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT
- ClinicalTrials.gov ID
- NCT06086938
- Acronym / sponsor ID
- CPSA07BJ40
- Conditions
- Stroke, Ischemic, Aphasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 17 Oct 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 current study aims to evaluate the efficacy and safety of pBFS-guided cTBS combined with iTBS for the rehabilitation of language functions 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, we 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 cTBS combined with iTBS intervention in post-stroke aphasic patients.
Subjects will be randomly assigned to the following two groups: active TBS（cTBS+iTBS）group, or a sham TBS（sham cTBS+sham iTBS）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 TBS group | Active comparator | Device: active cTBS combined with iTBSactive TBS combined with speech language therapy |
| sham TBS group | Sham comparator | Device: sham cTBS combined with iTBSsham TBS 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 acute ischemic stroke (diagnosed according to the "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" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, and a duration of ≥15 days and ≤3 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 functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school；
Key exclusion criteria (16 listed)
- Combined severe 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 cTBS combined with iTBSDaily TBS treatment consists of the following combination: active 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + active 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + active 600-pulse cTBS applied to the SFG in the unaffected hemisphere + active 600-pulses iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks. | Device | active TBS group |
| sham cTBS combined with iTBSDaily sham TBS treatment consists of the following combination: sham 600-pulse cTBS applied to the superior frontal gyrus (SFG) in the unaffected hemisphere + sham 600-pulse iTBS applied to the SFG in the affected hemisphere + 15 minutes of rest + sham 600-pulse cTBS applied to the SFG in the unaffected hemisphere + 600-pulse sham iTBS applied to the SFG in the affected hemisphere, totaling 2400 pulses of sham TBS intervention. The intervention mentioned above will be administered once per day with five consecutive days per week, continuously for three weeks. | Device | sham TBS 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.
3 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
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 23 Oct 2023.
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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, Ph.D. study chair
Changping Laboratory
Questions about this trial
What is this clinical trial studying?
A study testing active cTBS combined with iTBS in people with Stroke, Ischemic and Aphasia, run by Changping Laboratory.
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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 23 Oct 2023.