Stroke, IschemicNCT05842304
Individualized Precision rTMS for Language Recovery in Patients After Ischemic Stroke: a Multi-center RCT
A study testing active cTBS in people with Stroke, Ischemic and Aphasia, run by Changping Laboratory at 1 site in China.
Trial summary
The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic stroke aphasic patients. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2023to 10 May 2026
- 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 2 months and less than or equal to 1 year .
- 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, or with a history of stroke without apparent sequelae ( scored≤1 on modified Rankin Scale score (mRS) before the current 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
- Patients with comorbid severe dysarthria (NIHSS item 10 dysarthria ≥ 2).
- Aphasia caused by other diseases such as brain tumor, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, traumatic brain injury, etc.
- Patients with MRI scan and TMS treatment contraindications, such as claustrophobia, cardiac pacemaker, cochlear implant or other metallic foreign body and any electronic device implanted in the body.
- History of epilepsy (having at least 2 uninduced seizures more than 24h apart, or a diagnosis of epilepsy syndrome, or having seizures within the past 12 months).
- Patients with severe combined cardiac, pulmonary, hepatic, renal and other systemic diseases that cannot be controlled by conventional medication.
- Patients with comorbid disorders of consciousness ( NIHSS 1(a)≥1).
Show all 16Show fewer
- Patients with combined malignant hypertension (sudden and significant increase in blood pressure, with increased systolic and diastolic blood pressure, often persisting above 200/130 mmHg)
- Patients with co-malignant neoplasm.
- Patients with a life expectancy of less than 1 year due to causes other than stroke.
- Patients with combined deafness, visual impairment, or severe cognitive impairment to the extent that they are unable to cooperate with the test.
- Patients with severe depression, anxiety, or diagnosed with other mental disorders to the extent that they are unable to cooperate with the trial.
- History of TMS, transcranial electrical stimulation and other neuromodulation treatments in the past 3 months.
- History of alcohol, drug, and/or other abuse.
- Patients with other test abnormalities judged by the investigator to be unsuitable for the trial.
- Women of childbearing age who are pregnant or preparing for pregnancy.
- Patients who are participating in other clinical research trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Rehabilitation Research Center
Beijing
Hao Zhang, MD,PhD
About this study
Official title: Personalized Brain Functional Sectors (pBFS)-Guided rTMS Intervention for Aphasia After Ischemic Stroke: a Multi-center, Randomized, Parallel Controlled Study
The current multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic 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, 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 multi-center, double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized TMS 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 2:1. Subjects will receive a 3-week treatment for 21 consecutive days. The stimulation procedure will be assisted with real-time neuronavigation to ensure its precision.
- Conditions
- Stroke, Ischemic, Aphasia
- Being tested
- active cTBS, sham cTBS
- 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 cTBSDevice
Each patient will receive three 600-pulse cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks).
sham cTBSDevice
Each patient will receive three 600-pulse sham cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks).
| Study group | Role | What they receive |
|---|---|---|
| active cTBS group | Active comparator | active cTBS combined with conventional rehabilitation therapy Receives: Device: active cTBS |
| sham cTBS group | Sham comparator | Sham cTBS combined with conventional rehabilitation therapy Receives: Device: sham cTBS |
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 21-day therapy
Secondary outcomes (2)
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 7-day therapy, end of the follow-up of 3 weeks
National Institute of Health stroke scale
The 11-item National Institutes of Health Stroke Scale (NIHSS) will be used to evaluate participants' degree of neural deficits after stroke. Each item is associated with a specific ability, each scores between 0 to 4. The individual scores will be summed to calculate a participant's total NIHSS score. The total possible score is between 0 to 42, higher scores indicate worse outcomes.
Measured: baseline, end of the 21-day therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start5 Jun 2023
- Primary completion10 May 2025 (estimated)
- Study completion10 May 2026 (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
- 180 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
- NCT05842304
- Sponsor's protocol ID
- CPSA0290
- Status last verified
- May 2024
- First submitted
- 24 Apr 2023
- Last updated
- 20 Jun 2024
- 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 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sectors (pBFS)-Guided rTMS Intervention for Aphasia After Ischemic Stroke: a Multi-center, Randomized, Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT05842304
- Acronym / sponsor ID
- CPSA0290
- Conditions
- Stroke, Ischemic, Aphasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 6 May 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 multi-center study aims to evaluate the efficacy and safety of pBFS-guided rTMS Neuromodulation Treatment for the rehabilitation of language functions in ischemic 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, 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 multi-center, double-blinded, randomized and parallel controlled design trial, to investigate the efficacy and safety of pBFS-guided personalized TMS 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 2:1. Subjects will receive a 3-week treatment for 21 consecutive days. 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 cTBSactive cTBS combined with conventional rehabilitation therapy |
| sham cTBS group | Sham comparator | Device: sham cTBSSham cTBS combined with conventional rehabilitation 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 2 months and less than or equal to 1 year .
- 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, or with a history of stroke without apparent sequelae ( scored≤1 on modified Rankin Scale score (mRS) before the current 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)
- Patients with comorbid severe dysarthria (NIHSS item 10 dysarthria ≥ 2).
- Aphasia caused by other diseases such as brain tumor, Parkinson's syndrome, motor neuron disease, cerebral hemorrhage, traumatic brain injury, etc.
- Patients with MRI scan and TMS treatment contraindications, such as claustrophobia, cardiac pacemaker, cochlear implant or other metallic foreign body and any electronic device implanted in the body.
- History of epilepsy (having at least 2 uninduced seizures more than 24h apart, or a diagnosis of epilepsy syndrome, or having seizures within the past 12 months).
- Patients with severe combined cardiac, pulmonary, hepatic, renal and other systemic diseases that cannot be controlled by conventional medication.
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 cTBSEach patient will receive three 600-pulse cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks). | Device | active cTBS group |
| sham cTBSEach patient will receive three 600-pulse sham cTBS stimulations per day, parted by two 15-minute rest periods (a total of 1800 pulses daily), for 21 consecutive days (3 weeks). | Device | sham cTBS group |
Primary outcome
Change in the Western Aphasia Battery scores
Time frame: baseline, end of the 21-day 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.
2 secondary outcomes
Change in the Western Aphasia Battery scores
Time frame: baseline, end of the 7-day therapy, end of the follow-up of 3 weeks
National Institute of Health stroke scale
Time frame: baseline, end of the 21-day therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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
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 cTBS 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 20 Jun 2024. 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 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 21-day 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 20 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.