Ischemic StrokeNCT07637825
Transcranial Focused Ultrasound Neuromodulation for Post-Stroke Motor Dysfunction
A study testing Transcranial Focused Ultrasound Neuromodulation in people with Ischemic Stroke, run by Jiangsu Taizhou People's Hospital at 1 site in China.
Trial summary
This study aims to evaluate how transcranial focused ultrasound (tFUS) technology can promote neural network remodeling and functional recovery after stroke. By integrating signals from electroencephalography (EEG) and magnetic resonance imaging (MRI), the study will investigate how activating or inhibiting specific… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Transcranial Focused Ultrasound Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2026to 31 Mar 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Patients with a confirmed imaging diagnosis of first-ever ischemic stroke; (2) Unilateral limb motor involvement; (3) Modified Ashworth Scale (MAS) grade ≤3 for the upper extremity, Brunnstrom stage II-V, and upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60 (inclusive); (4) Age 18-75 years, onset within 21 days to 6 months, in the subacute or recovery phase; (5) Stable vital signs, no consciousness impairment, informed consent provided, ability to cooperate with clinical assessments, and approval obtained from the institutional ethics committee.
Who cannot join
- (1) Contraindications to MRI; (2) Infarction involving the thalamus; (3) Risk of intracranial hemorrhage; (4) Presence of intracranial metallic foreign bodies, cardiac pacemakers, or cochlear implants; (5) Unstable medical condition, severe cognitive impairment or psychiatric disorders rendering the patient unable to comprehend the study or cooperate with assessments; (6) Conditions affecting limb motor function, including fractures, joint contractures, or severe limb spasticity; (7) Current use of medications that alter cortical excitability.
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, 1 recruiting
- Recruiting
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
Gaonian Zhao, +86 13951170428, zhaogaonian@163.com
About this study
Official title: Transcranial Focused Ultrasound Neuromodulation in Post-Stroke Motor Dysfunction
This study aims to evaluate how transcranial focused ultrasound (tFUS) technology can promote neural network remodeling and functional recovery after stroke. By integrating signals from electroencephalography (EEG) and magnetic resonance imaging (MRI), the study will investigate how activating or inhibiting specific brain regions affects motor and cognitive recovery. The goal is to improve patients' motor and cognitive functions, reduce long-term disability, and enhance quality of life. The study also seeks to optimize stimulation parameters to maximize rehabilitation outcomes and explore the mechanisms underlying neuroprotection and functional reconstruction after stroke.
This is a case-control study involving a total of 60 participants. Participants will be ischemic stroke survivors aged 18-75 years, with first-ever stroke onset between 21 days and 6 months, stable vital signs, no consciousness disorders, and the ability to provide informed consent and cooperate with assessments. Eligible participants must have unilateral limb motor impairment, with an upper extremity modified Ashworth score ≤3, Brunnstrom stage II-V, and an upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60.
Read more
Participants will be assigned to either a neuromodulation group (receiving multi-modal neuromodulation targeting specific brain regions) or a control group (receiving sham stimulation or conventional treatment). Primary outcome measures include changes in FMA-UE scores, neuroimaging data (CT/MRI), EEG measurements (resting-state and task-state spectral power, functional connectivity), and laboratory markers (complete blood count, CRP, IL-6, S100β, BDNF). Secondary outcome measures include Brunnstrom stage, Ashworth grade, muscle strength, and patient comfort ratings. Safety will be monitored through blood routine tests, blood biochemistry, and coagulation function.
Statistical analysis will compare key indicator changes between the neuromodulation and control groups before and after intervention. Independent t-tests (for two groups) or ANOVA (for multiple groups) will be used to assess between-group differences, with non-parametric tests applied for data not following a normal distribution.
- Conditions
- Ischemic Stroke
- Being tested
- Transcranial Focused Ultrasound Neuromodulation, Sham Transcranial Focused Ultrasound Neuromodulation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Focused Ultrasound NeuromodulationDevice
The transcranial focused ultrasound stimulation device employed in this study is the NeuroFUS DPX-500, equipped with a 4-element transducer array and the BrainSight neuronavigation system. Individualized modeling and target segmentation are performed using high-resolution structural MRI and CT images acquired at baseline. Target planning and neuronavigation are conducted based on intracranial acoustic field simulation. The total stimulation duration is 12 minutes, comprising 480 pulse trains with 0.5 seconds on and 1 second off, yielding a duty cycle of 20%.
Sham Transcranial Focused Ultrasound NeuromodulationDevice
The control group receives sham stimulation during the neuromodulation phase. All procedural steps are identical to those of the experimental group, including neuronavigation positioning, application of coupling gel, and all other preparatory procedures; however, ultrasound stimulation is not activated. Participants in the control group wear bone-conduction headphones to simulate and counteract acoustic confounding. Group allocation information is blinded to participants.
| Study group | Role | What they receive |
|---|---|---|
| Neuromodulation Group | Experimental | Multimodal neuromodulation targeting specific neural regions in addition to conventional therapy. Receives: Device: Transcranial Focused Ultrasound Neuromodulation |
| Control Group | Sham comparator | Sham stimulation in addition to conventional therapy. Receives: Device: Sham Transcranial Focused Ultrasound Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score
Upper extremity motor function assessed by the Fugl-Meyer Assessment (motor subscale). Total score ranges from 0 to 66, with higher scores indicating better motor function.
Measured: Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up)
Resting-state EEG spectral power
Resting-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
Measured: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Task-state EEG spectral power
Task-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
Measured: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Resting-state fMRI fractional ALFF (fALFF)
fALFF derived from resting-state functional MRI, the ratio of low-frequency power to whole-frequency power.
Measured: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Resting-state fMRI regional homogeneity (ReHo)
ReHo (Kendall's coefficient of concordance) from resting-state functional MRI, reflecting local synchronization of neuronal activity.
Measured: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Resting-state fMRI functional connectivity (FC)
Functional connectivity between regions of interest derived from resting-state functional MRI (Fisher z-transformed correlation coefficients).
Measured: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Secondary outcomes (3)
Brunnstrom recovery stage of the affected upper limb
Motor recovery staged using the Brunnstrom approach, an ordinal scale from Stage 1 (flaccid, no movement) to Stage 6 (near-normal coordination), with higher stages indicating better motor recovery.
Measured: Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
Modified Ashworth Scale (MAS) grade of the affected upper limb
Muscle spasticity graded with the Modified Ashworth Scale, an ordinal scale with 6 levels (0, 1, 1+, 2, 3, 4); higher grades indicate greater spasticity (a worse outcome).
Measured: Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
Fractional anisotropy (FA) on diffusion tensor imaging (DTI)
White-matter fractional anisotropy measured by diffusion tensor imaging. Dimensionless (0-1), with higher values indicating greater directional coherence of water diffusion.
Measured: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start9 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harbin Institute of Technology
- Responsible party
- Principal investigator, Ming Chu, Jiangsu Taizhou People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637825
- Sponsor's protocol ID
- LSKY 2026-040-01
- Status last verified
- Oct 2026
- First submitted
- 18 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent obtained from participants does not include provisions for sharing data outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Focused Ultrasound Neuromodulation in Post-Stroke Motor Dysfunction
- ClinicalTrials.gov ID
- NCT07637825
- Acronym / sponsor ID
- LSKY 2026-040-01
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Taizhou People's HospitalUniversity, hospital or other
- Collaborators
- Harbin Institute of Technology
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 10 Jun 2026 (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 study aims to evaluate how transcranial focused ultrasound (tFUS) technology can promote neural network remodeling and functional recovery after stroke. By integrating signals from electroencephalography (EEG) and magnetic resonance imaging (MRI), the study will investigate how activating or inhibiting specific brain regions affects motor and cognitive recovery. The goal is to improve patients' motor and cognitive functions, reduce long-term disability, and enhance quality of life. The study also seeks to optimize stimulation parameters to maximize rehabilitation outcomes and explore the mechanisms underlying neuroprotection and functional reconstruction after stroke.
This is a case-control study involving a total of 60 participants. Participants will be ischemic stroke survivors aged 18-75 years, with first-ever stroke onset between 21 days and 6 months, stable vital signs, no consciousness disorders, and the ability to provide informed consent and cooperate with assessments. Eligible participants must have unilateral limb motor impairment, with an upper extremity modified Ashworth score ≤3, Brunnstrom stage II-V, and an upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60.
Participants will be assigned to either a neuromodulation group (receiving multi-modal neuromodulation targeting specific brain regions) or a control group (receiving sham stimulation or conventional treatment). Primary outcome measures include changes in FMA-UE scores, neuroimaging data (CT/MRI), EEG measurements (resting-state and task-state spectral power, functional connectivity), and laboratory markers (complete blood count, CRP, IL-6, S100β, BDNF). Secondary outcome measures include Brunnstrom stage, Ashworth grade, muscle strength, and patient comfort ratings. Safety will be monitored through blood routine tests, blood biochemistry, and coagulation function.
Statistical analysis will compare key indicator changes between the neuromodulation and control groups before and after intervention. Independent t-tests (for two groups) or ANOVA (for multiple groups) will be used to assess between-group differences, with non-parametric tests applied for data not following a normal distribution.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromodulation Group | Experimental | Device: Transcranial Focused Ultrasound NeuromodulationMultimodal neuromodulation targeting specific neural regions in addition to conventional therapy. |
| Control Group | Sham comparator | Device: Sham Transcranial Focused Ultrasound NeuromodulationSham stimulation in addition to conventional therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) Patients with a confirmed imaging diagnosis of first-ever ischemic stroke; (2) Unilateral limb motor involvement; (3) Modified Ashworth Scale (MAS) grade ≤3 for the upper extremity, Brunnstrom stage II-V, and upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60 (inclusive); (4) Age 18-75 years, onset within 21 days to 6 months, in the subacute or recovery phase; (5) Stable vital signs, no consciousness impairment, informed consent provided, ability to cooperate with clinical assessments, and approval obtained from the institutional ethics committee.
Key exclusion criteria (1 listed)
- (1) Contraindications to MRI; (2) Infarction involving the thalamus; (3) Risk of intracranial hemorrhage; (4) Presence of intracranial metallic foreign bodies, cardiac pacemakers, or cochlear implants; (5) Unstable medical condition, severe cognitive impairment or psychiatric disorders rendering the patient unable to comprehend the study or cooperate with assessments; (6) Conditions affecting limb motor function, including fractures, joint contractures, or severe limb spasticity; (7) Current use of medications that alter cortical excitability.
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 |
|---|---|---|
| Transcranial Focused Ultrasound NeuromodulationThe transcranial focused ultrasound stimulation device employed in this study is the NeuroFUS DPX-500, equipped with a 4-element transducer array and the BrainSight neuronavigation system. Individualized modeling and target segmentation are performed using high-resolution structural MRI and CT images acquired at baseline. Target planning and neuronavigation are conducted based on intracranial acoustic field simulation. The total stimulation duration is 12 minutes, comprising 480 pulse trains with 0.5 seconds on and 1 second off, yielding a duty cycle of 20%. | Device | Neuromodulation Group |
| Sham Transcranial Focused Ultrasound NeuromodulationThe control group receives sham stimulation during the neuromodulation phase. All procedural steps are identical to those of the experimental group, including neuronavigation positioning, application of coupling gel, and all other preparatory procedures; however, ultrasound stimulation is not activated. Participants in the control group wear bone-conduction headphones to simulate and counteract acoustic confounding. Group allocation information is blinded to participants. | Device | Control Group |
Primary outcome
Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score
Time frame: Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up)
Upper extremity motor function assessed by the Fugl-Meyer Assessment (motor subscale). Total score ranges from 0 to 66, with higher scores indicating better motor function.
Resting-state EEG spectral power
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Resting-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
Task-state EEG spectral power
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Task-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
Resting-state fMRI fractional ALFF (fALFF)
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
fALFF derived from resting-state functional MRI, the ratio of low-frequency power to whole-frequency power.
Resting-state fMRI regional homogeneity (ReHo)
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
ReHo (Kendall's coefficient of concordance) from resting-state functional MRI, reflecting local synchronization of neuronal activity.
Resting-state fMRI functional connectivity (FC)
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
Functional connectivity between regions of interest derived from resting-state functional MRI (Fisher z-transformed correlation coefficients).
3 secondary outcomes
Brunnstrom recovery stage of the affected upper limb
Time frame: Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
Modified Ashworth Scale (MAS) grade of the affected upper limb
Time frame: Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
Fractional anisotropy (FA) on diffusion tensor imaging (DTI)
Time frame: Baseline (Day 1) and Day 7 (after the 5-day intervention)
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 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent obtained from participants does not include provisions for sharing data outside the research team.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Focused Ultrasound Neuromodulation in people with Ischemic Stroke, run by Jiangsu Taizhou People's 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Oct 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. 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?
Contact Gaonian Zhao (+86 13951170428, zhaogaonian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score (time frame: Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up)). The study lists 6 primary outcomes in all. 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 6 Oct 2026.