Stroke, AcuteRETRACE-INCT06064734
Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours
A study testing LF-rTMS in people with Stroke, Acute and Stroke, Ischemic, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a multicenter, open-label, evaluator-blinded, investigator-initiated, randomized clinical trial, to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute, Stroke, Ischemic
- What is being tested?
- LF-rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2024to 25 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, gender is not limited;
- Acute ischemic stroke of anterior circulation was diagnosed clinically
- mRS 0-1 score before onset;
- 6 ≤ NIHSS ≤25 at randomization;
- Within 48 hours of stroke onset;
- No thrombolysis therapy or thrombectomy is planned;
- Obtain informed consent signed by the patient himself or by his legal authorized representative.
Who cannot join
- TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
- Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
- Midline displacement and brain parenchymal mass effect seen in head CT and other images;
- Head CT or MRI showed bilateral acute cerebral infarction, brainstem infarction, or insular infarction;
- Evidence of acute intracranial hemorrhage;
- A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;
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- After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg;
- Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (EGFR) < 60 mL/min;
- Patients during pregnancy or lactation and within 90 days of planned pregnancy;
- Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up;
- Patients with malignancy or severe systemic disease and expected survival of less than 90 days;
- Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours (RETRACE-I): A Randomized, Open-label, Evaluator-blinded, Phase 2 Pilot Trial
This is a multicenter, open-label, evaluator-blinded, investigator-initiated, randomized clinical trial, to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset.
Read the detailed description
The target population of this study was patients with clinically diagnosed AIS who had an acute occlusion of the responsible vessel in the anterior circulation and were not scheduled for intravenous thrombolysis and/or endovascular therapy, the time from stroke onset to the start of study intervention was less than 48-hours.
Enrolled patients were randomly assigned in a 1:1 ratio to either the"LF-rTMS group" or the"Control group" to receive:
- LF-rTMS group: H 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses).
- Control group: received routine treatment.
All the above therapeutic interventions were conducted by trained TMS operators. Except for the study intervention, the subjects in both groups received clinical routine diagnosis and treatment which were not affected by the intervention.
All patients were followed up until the 90th day after randomization to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset.
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Being tested
- LF-rTMS
- Keywords
- Acute Ischemic Stroke, LF-rTMS, Phase 2 Pilot Trial
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LF-rTMSDevice
H 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses).
| Study group | Role | What they receive |
|---|---|---|
| LF-rTMS | Experimental | H 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses). Receives: Device: LF-rTMS |
| Control | No intervention | Routine treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct growth from baseline to Day 3 (mL)
Infarct growth at 3 days was calculated as the absolute difference between the baseline core infarct volume and the 3 days post-randomization infarct volume. Positive values indicate infarct growth.
Measured: 3 days
Symptomatic intracranial hemorrhage
The proportion of symptomatic intracranial hemorrhage
Measured: 3 days
Secondary outcomes (14)
Proportion of Early neurological improvement (ENI)
Proportion of patients with a reduction of ≥4 on the NIHSS, compared with the baseline score or an NIHSS of 0 or 1
Measured: 3 days
Final infarct volume at Day 3 (mL)
Final infarct volume, in milliliters, measured 3 days after randomization.
Measured: 3 days
Change in NIHSS score from baseline to Day 3
Change in NIHSS score from baseline to Day 3
Measured: 3 days
Proportion of participants with modified Rankin Scale score 0 to 1 at Day 90
Proportion of participants with modified Rankin Scale score 0 to 1 at Day 90
Measured: 90 days
Proportion of participants with modified Rankin Scale score 0 to 2 at Day 90
Proportion of participants with modified Rankin Scale score 0 to 2 at Day 90
Measured: 90 days
Barthel index of ADL
Barthel index of ADL, 0-100 (better)
Measured: 90 days
EQ-5D-5L
The Health Questionnaire (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Measured: 90 days
Montreal Cognitive Assessment (MoCA) total score
Total score of the MoCA Performance on the MoCA (0-30; higher score indicates better performance)
Measured: 90 days
Number of participants with neurological deterioration within 3 days
The incidence of deterioration of neurological function (NIHSS increase ≥4 points)
Measured: 3 days
Number of participants with symptomatic intracranial hemorrhage within 90 days
Number of participants with symptomatic intracranial hemorrhage within 90 days
Measured: 90 days
All-cause deaths
The proportion of all-cause deaths
Measured: 90 days
Stroke recurrence
Recurrence rate of symptomatic stroke (cerebral infarction, cerebral hemorrhage)
Measured: 90 days
Serious adverse events
The proportion of serious adverse events (SAE)
Measured: 90 days
Adverse events (AE)
The proportion of adverse events (AE)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start11 Mar 2024
- Primary completion28 Jul 2025
- Study completion25 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Yongjun Wang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064734
- Sponsor's protocol ID
- HX-A-2023001
- Acronym
- RETRACE-I
- Status last verified
- Apr 2026
- First submitted
- 24 Aug 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ding L, Lv S, Wang W, Ji Z, Gong X, Jia Q, Yang X, Zang Y, Huang S, Tan Z, Wang Y, Li Z. Low-FREquency Deep TRanscranial Magnetic Stimulation in ACute Ischaemic StrokE within 48 Hours (RETRACE-I): rationale and design of a randomised, multicentre, open-label, blinded endpoint trial. Stroke Vasc Neurol. 2026 Apr 30:svn-2025-004778. doi: 10.1136/svn-2025-004778. Online ahead of print.
PubMed 42061988
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours (RETRACE-I): A Randomized, Open-label, Evaluator-blinded, Phase 2 Pilot Trial
- ClinicalTrials.gov ID
- NCT06064734
- Acronym / sponsor ID
- RETRACE-I / HX-A-2023001
- Conditions
- Stroke, Acute, Stroke, Ischemic
- Keywords
- Acute Ischemic Stroke, LF-rTMS, Phase 2 Pilot Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 25 Oct 2025 (actual)
- First posted
- 3 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.
This is a multicenter, open-label, evaluator-blinded, investigator-initiated, randomized clinical trial, to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset.
Detailed description
The target population of this study was patients with clinically diagnosed AIS who had an acute occlusion of the responsible vessel in the anterior circulation and were not scheduled for intravenous thrombolysis and/or endovascular therapy, the time from stroke onset to the start of study intervention was less than 48-hours.
Enrolled patients were randomly assigned in a 1:1 ratio to either the"LF-rTMS group" or the"Control group" to receive:
- LF-rTMS group: H 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses).
- Control group: received routine treatment.
All the above therapeutic interventions were conducted by trained TMS operators. Except for the study intervention, the subjects in both groups received clinical routine diagnosis and treatment which were not affected by the intervention.
All patients were followed up until the 90th day after randomization to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LF-rTMS | Experimental | Device: LF-rTMSH 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses). |
| Control | No intervention | –Routine treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years, gender is not limited;
- Acute ischemic stroke of anterior circulation was diagnosed clinically
- mRS 0-1 score before onset;
- 6 ≤ NIHSS ≤25 at randomization;
- Within 48 hours of stroke onset;
Key exclusion criteria (12 listed)
- TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
- Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
- Midline displacement and brain parenchymal mass effect seen in head CT and other images;
- Head CT or MRI showed bilateral acute cerebral infarction, brainstem infarction, or insular infarction;
- Evidence of acute intracranial hemorrhage;
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 |
|---|---|---|
| LF-rTMSH 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses). | Device | LF-rTMS |
Primary outcome
Infarct growth from baseline to Day 3 (mL)
Time frame: 3 days
Infarct growth at 3 days was calculated as the absolute difference between the baseline core infarct volume and the 3 days post-randomization infarct volume. Positive values indicate infarct growth.
Symptomatic intracranial hemorrhage
Time frame: 3 days
The proportion of symptomatic intracranial hemorrhage
14 secondary outcomes
Proportion of Early neurological improvement (ENI)
Time frame: 3 days
Final infarct volume at Day 3 (mL)
Time frame: 3 days
Change in NIHSS score from baseline to Day 3
Time frame: 3 days
Proportion of participants with modified Rankin Scale score 0 to 1 at Day 90
Time frame: 90 days
Proportion of participants with modified Rankin Scale score 0 to 2 at Day 90
Time frame: 90 days
Barthel index of ADL
Time frame: 90 days
EQ-5D-5L
Time frame: 90 days
Montreal Cognitive Assessment (MoCA) total score
Time frame: 90 days
Number of participants with neurological deterioration within 3 days
Time frame: 3 days
Number of participants with symptomatic intracranial hemorrhage within 90 days
Time frame: 90 days
All-cause deaths
Time frame: 90 days
Stroke recurrence
Time frame: 90 days
Serious adverse events
Time frame: 90 days
Adverse events (AE)
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Derived from this study: PubMed 42061988Ding L, Lv S, Wang W, Ji Z, Gong X, Jia Q, Yang X, Zang Y, Huang S, Tan Z, Wang Y, Li Z. Low-FREquency Deep TRanscranial Magnetic Stimulation in ACute Ischaemic StrokE within 48 Hours (RETRACE-I): rationale and design of a randomised, multicentre, open-label, blinded endpoint trial. Stroke Vasc Neurol. 2026 Apr 30:svn-2025-004778. doi: 10.1136/svn-2025-004778. Online ahead of print.
- 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.
Yongjun Wang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LF-rTMS in people with Stroke, Acute and Stroke, Ischemic, run by Beijing Tiantan Hospital 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 7 inclusion and 12 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: finished, as of the sponsor's last update on 15 Apr 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infarct growth from baseline to Day 3 (mL) (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064734, which also lists 1 linked publication.
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 15 Apr 2026.