StrokeNCT06787508
Exploration of Repeated High-frequency Transcranial Magnetic Stimulation for the Treatment of Acute Phase Aphasia in Post-stroke Patients
A study testing TMS in people with Stroke and Aphasia, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Stroke is currently an important cause of death and disability among adults worldwide, with acute ischemic stroke being the most common type of stroke, accounting for 69.6% -72.8% of new strokes in China. The time division of the acute phase generally refers to the onset time within 1-2 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Aphasia, Control Patients
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:1) Age ≥ 18 years old 2) Head MR confirms new onset of cerebral infarction, and aphasia symptoms are caused by cerebral infarction 3) Patient's hospitalization history is within 7 days 4) Can cooperate to complete all required inspection items and scales 5) Sign informed consent form 6) Right handed -
Exclusion Criteria:1)Patients with aphasia caused by non cerebral infarction,2) Non acute phase cerebral infarction patients with a course of more than 7 days 3) Severe neurological disorders other than stroke, such as epilepsy and hemorrhagic stroke, are combined 4) Patients with poor general condition and unable to complete relevant examinations and scale scores, such as patients with malignant arrhythmia, tumor, severe infection, malignant hypertension, diabetes hyperosmolar coma, etc 5) Previous or current comorbidities of severe mental illnesses, such as depression, schizophrenia, etc 6) Patients who have previously or currently taken sedatives or large amounts of sleep aids 7) Contraindications for combined transcranial magnetic stimulation: presence of metal or other implants (such as pacemakers) in the body 8) Pregnancy and lactation period
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Municipality Directly Under the Central Government, 400000
About this study
Stroke is currently an important cause of death and disability among adults worldwide, with acute ischemic stroke being the most common type of stroke, accounting for 69.6% -72.8% of new strokes in China. The time division of the acute phase generally refers to the onset time within 1-2 weeks. About 21-38% of stroke patients have post-stroke aphasia. Post stroke aphasia is usually an acquired language disorder caused by damage to the language functional areas of the dominant hemisphere, characterized by varying degrees of impairment in some or all language functions, including speaking, listening and understanding, paraphrasing, naming, reading, and calligraphy abilities. Rehabilitation treatment for cerebral infarction should be done early rather than late. Based on this, this study aims to explore transcranial magnetic stimulation therapy for post-stroke aphasia patients in the acute phase. By regulating the balance of cortical excitability on both sides of the healthy and affected areas, early speech function rehabilitation can be achieved, which is necessary for improving the quality of life of post-stroke aphasia patients
Read the detailed description
Post stroke aphasia (PSA) is an acquired communication disorder caused by brain injury, characterized by various functional impairments such as self speech, repetition, naming, auditory comprehension, reading, and writing. PSA is one of the serious sequelae of stroke, which seriously affects the quality of life of patients. Early intervention in speech therapy can to some extent restore patients' functional communication abilities. Transcranial magnetic stimulation (TMS) is currently the most widely used non-invasive therapy. TMS can generate a magnetic field through the principle of magnetoelectric conversion, which can penetrate the skull and generate a super threshold current, allowing neurons in the target brain area to discharge. High frequency rTMS (generally frequency>5HZ) is usually applied to the affected side, aiming to improve aphasia symptoms by directly promoting the excitability of the affected cortex.
The rehabilitation treatment for PSA patients often stabilizes within a few months after stroke, and early intervention may maximize potential benefits. At present, research on high-frequency rTMS is mostly limited to the subacute or chronic phase. Therefore, this study aims to explore a safe and effective TMS treatment method during the acute phase.
- Conditions
- Stroke, Aphasia, Control Patients
- Being tested
- TMS
- Keywords
- Post stroke aphasia, TMS
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Continuous high-frequency transcranial magnetic stimulation therapy Targeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days
TMSDevice
Consistent with the experimental group protocol, the magnetic stimulation probe is a false stimulation probe that only produces sound but does not actually produce stimulation
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Targeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days Receives: Device: TMS |
| Control group | Sham comparator | Consistent with the experimental group protocol, the magnetic stimulation probe is a false stimulation probe, which only produces sound but does not actually produce stimulation Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDAE Scale Score
Collect the scores of the experimental group/control group on the Aphasia Scale before and after treatment, calculate the difference in scores for each patient and the average value of each component. Assuming that the average difference between groups is greater than 20%, it is considered that there is a significant difference
Measured: From before treatment to 1 month after treatment, a total of 3 time points
Secondary outcomes (1)
Electrophysiological measurement
By collecting EEG/TMS data from patients, evaluate their electrophysiological characteristics and related changes at three time points from before treatment to one month after treatment
Measured: From before treatment to 1 month after treatment, a total of 3 time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start15 Mar 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (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.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Xiao, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Fei Xiao, Professor, Study director, First Affiliated Hospital of Chongqing Medical UniversityJing Luo, associate professor, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787508
- Sponsor's protocol ID
- 2024-335-01
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With the consent of both researchers and participants, the original data can be obtained by contacting with the corresponding member.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Repeated High-frequency Transcranial Magnetic Stimulation for the Treatment of Acute Phase Aphasia in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT06787508
- Acronym / sponsor ID
- 2024-335-01
- Conditions
- Stroke, Aphasia, Control Patients
- Keywords
- Post stroke aphasia, TMS
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Jan 2025 (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.
Stroke is currently an important cause of death and disability among adults worldwide, with acute ischemic stroke being the most common type of stroke, accounting for 69.6% -72.8% of new strokes in China. The time division of the acute phase generally refers to the onset time within 1-2 weeks. About 21-38% of stroke patients have post-stroke aphasia. Post stroke aphasia is usually an acquired language disorder caused by damage to the language functional areas of the dominant hemisphere, characterized by varying degrees of impairment in some or all language functions, including speaking, listening and understanding, paraphrasing, naming, reading, and calligraphy abilities. Rehabilitation treatment for cerebral infarction should be done early rather than late. Based on this, this study aims to explore transcranial magnetic stimulation therapy for post-stroke aphasia patients in the acute phase. By regulating the balance of cortical excitability on both sides of the healthy and affected areas, early speech function rehabilitation can be achieved, which is necessary for improving the quality of life of post-stroke aphasia patients
Detailed description
Post stroke aphasia (PSA) is an acquired communication disorder caused by brain injury, characterized by various functional impairments such as self speech, repetition, naming, auditory comprehension, reading, and writing. PSA is one of the serious sequelae of stroke, which seriously affects the quality of life of patients. Early intervention in speech therapy can to some extent restore patients' functional communication abilities. Transcranial magnetic stimulation (TMS) is currently the most widely used non-invasive therapy. TMS can generate a magnetic field through the principle of magnetoelectric conversion, which can penetrate the skull and generate a super threshold current, allowing neurons in the target brain area to discharge. High frequency rTMS (generally frequency>5HZ) is usually applied to the affected side, aiming to improve aphasia symptoms by directly promoting the excitability of the affected cortex.
The rehabilitation treatment for PSA patients often stabilizes within a few months after stroke, and early intervention may maximize potential benefits. At present, research on high-frequency rTMS is mostly limited to the subacute or chronic phase. Therefore, this study aims to explore a safe and effective TMS treatment method during the acute phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: TMSTargeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days |
| Control group | Sham comparator | Device: TMSConsistent with the experimental group protocol, the magnetic stimulation probe is a false stimulation probe, which only produces sound but does not actually produce stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| TMSContinuous high-frequency transcranial magnetic stimulation therapy Targeting the left M1 area, continuous high-frequency stimulation was performed at a frequency of 10Hz with 80-100% TEP for 5 minutes each time, twice a day for a total of 5 days | Device | Test group |
| TMSConsistent with the experimental group protocol, the magnetic stimulation probe is a false stimulation probe that only produces sound but does not actually produce stimulation | Device | Control group |
Primary outcome
BDAE Scale Score
Time frame: From before treatment to 1 month after treatment, a total of 3 time points
Collect the scores of the experimental group/control group on the Aphasia Scale before and after treatment, calculate the difference in scores for each patient and the average value of each component. Assuming that the average difference between groups is greater than 20%, it is considered that there is a significant difference
1 secondary outcome
Electrophysiological measurement
Time frame: From before treatment to 1 month after treatment, a total of 3 time points
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. With the consent of both researchers and participants, the original data can be obtained by contacting with the corresponding member.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Fei Xiao, Professor study director
First Affiliated Hospital of Chongqing Medical University
Jing Luo, associate professor principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Stroke and Aphasia, run by First Affiliated Hospital of Chongqing Medical University 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?
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: enrolling by invitation, as of the sponsor's last update on 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDAE Scale Score (time frame: From before treatment to 1 month after treatment, a total of 3 time points). 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 3 Apr 2025.