StrokeNCT07833423
Efficacy of Temporal Interference-based Deep Brain Stimulation Combined With Conventional Rehabilitation Training for Lower Limb Motor Dysfunction After Stroke
A study testing Transcranial Temporal Interference (TI) Stimulation and routine rehabilitation in people with Stroke, run by The Third People's Hospital of Huizhou.
Trial summary
Stroke, as one of the most disabling neurological diseases worldwide, causes significant functional impairments in the lower limbs, severely affecting the quality of life of patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial Temporal Interference (TI) Stimulation and routine rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Sep 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
- The patients met the diagnostic criteria of stroke formulated by the Fourth National Cerebrovascular Disease Conference and were confirmed by head CT or MRI.
- The duration of the first episode ranged from 1 to 6 months.
- Age ranged from 18 to 75 years and both sexes were included.
- There was definite lower limb dysfunction, and Brunnstrom stage of lower limbs was II-IV.
- Informed consent was obtained voluntarily.
Who cannot join
- People with metallic implants (e.g., aneurysm clips, pacemakers) or skull defects.
- Have a history of epilepsy or are taking medications that may lower the seizure threshold.
- Patients with severe heart, liver, kidney dysfunction or other serious physical diseases.
- Pregnant or lactating women.
- Patients with skin allergy or skin lesions at irritating sites.
- Hemorrhagic lesions in the basal ganglia (including previous or current basal ganglia hemorrhage).
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- Impairment of lower limb mobility due to other nonstroke factors was sufficient to significantly affect the primary outcome assessor.
- Inability to cooperate with investigators.
- At the same time, he participated in other research projects.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Temporal Interference-based Deep Brain Stimulation Combined With Conventional Rehabilitation Training for Lower Limb Motor Dysfunction After Stroke: A Prospective Randomized Controlled Clinical Trial
Stroke, as one of the most disabling neurological diseases worldwide, causes significant functional impairments in the lower limbs, severely affecting the quality of life of patients. Traditional neuroregulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current/alternating current stimulation (tDCS/tACS) can only intervene in the cerebral cortex. Deep brain stimulation (DBS), which requires invasive craniotomy to implant electrodes and has certain risks, is difficult to fully meet the rehabilitation needs of patients. These treatment methods are insufficient. Transcranial Temporal Interference (TI) Stimulation, as a new non-invasive neuroregulation technology, generates low-frequency envelope signals through high-frequency electric fields to achieve precise stimulation of deep brain tissues, providing a new direction for the treatment of stroke. This study is a clinical research to explore the efficacy of TI technology in the treatment of lower limb dysfunction in stroke, aiming to expand the clinical practice of TI technology in the field of stroke rehabilitation and provide theoretical support and practical guidance for the transformation and application of TI technology.
- Conditions
- Stroke
- Being tested
- Transcranial Temporal Interference (TI) Stimulation, routine rehabilitation, TI sham stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Temporal Interference (TI) StimulationDevice
The stimulation target selected by TI was the contralateral striatum (caudate nucleus), and a head model was constructed based on individualized cranial MRI (T1-weighted image). The 8-12 electrode configuration scheme was optimized using online platforms such as NervioWeb. Stimulation parameters: carrier frequency of 2 kHz and 2.020 kHz, generating a 20 Hz envelope; initial current intensity of 2 mA per electrode, gradually increasing to the tolerated upper limit (single electrode ≤ 5 mA, total current ≤ 10 mA); 20 minutes each time, 5 times a week, for a total of 3 weeks.
routine rehabilitationOther
The routine rehabilitation strictly follows the standard treatment protocols recommended by domestic and international guidelines such as "Chinese Guidelines for Stroke Rehabilitation Therapy", including secondary prevention with medication, task-oriented lower limb muscle strength training, balance training, gait correction training, and physical factor therapy. This is carried out by rehabilitation therapists according to the hospital's routine procedures, 5 times a week, each session lasting approximately 60 minutes, for a total of 3 weeks.
TI sham stimulationDevice
The electrode application, positioning, and equipment operation procedures are exactly the same as those in the true stimulation group. The current gradually increases from a 30-second ramp to the preset intensity and then immediately returns to zero. Only the first 30 seconds cause a slight sensation on the scalp, and no effective modulated electric field is generated thereafter. 20 minutes each time, 5 times a week, for a total of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation group | Sham comparator | The routine rehabilitation strictly follows the standard treatment protocols (SOC) recommended by domestic and international guidelines such as the "Chinese Guidelines for Stroke Rehabilitation Therapy", including secondary prevention with medication, task-oriented lower limb muscle strength training, balance training, gait correction training, and physical factor therapy. This is carried out by rehabilitation therapists according to the hospital's routine procedures, 5 times a week, each session lasting approximately 60 minutes, for a total of 3 weeks. The TI stimulation is a sham stimulation. Specifically, the electrode application, positioning, and equipment operation procedures are exactly the same as those in the true stimulation group. The current rises gradually from a 30-second slope to the preset intensity and then immediately returns to zero. Only the first 30 seconds produce a slight scalp sensation, and there is no effective modulated electric field thereafter. Receives: Other: routine rehabilitation; Device: TI sham stimulation |
| True stimulation group | Experimental | The conventional rehabilitation was the same as the sham stimulation group. On this basis, for the TI stimulation, the target area was selected as the affected side striatum (caudate nucleus), and a head model was constructed based on individualized cranial MRI (T1-weighted image). The NervioWeb and other online platforms were used to optimize the 8-12 electrode configuration scheme. Stimulation parameters: carrier frequency of 2 kHz and 2.020 kHz, generating a 20 Hz envelope; initial current intensity of 2 mA per electrode, gradually increasing to the tolerance limit (single electrode ≤ 5 mA, total current ≤ 10 mA); 20 minutes each time, 5 times a week, for a total of 3 weeks. Receives: Device: Transcranial Temporal Interference (TI) Stimulation; Other: routine rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity part of Fugl-Meyer rating scale
The Fugl-Meyer Assessment Lower Extremity component (FMA-LE) is a standardized tool for the assessment of lower limb motor function in patients after stroke. It contains 17 items and is divided into two subscales: lower limb motor and coordination/speed . Higher scores indicate better function. For each item, a score of 0 indicates unable to complete/no function, a score of 1 indicates partially completed/partially functional, and a score of 2 indicates fully completed/normal function.
Measured: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Secondary outcomes (5)
Holden Functional grading assessment scale for walking
Holden functional classification of walking scale is a classic observational scale to assess the walking independence of patients
Measured: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Berg Balance Scale
For the balance function of the lower limbs, the Berg balance Scale was used. The scale contains 14 items covering tasks of varying difficulty ranging from balance in a sitting position to standing on one leg. Each item was scored on a 5-point scale from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance.
Measured: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Modified Barthel Index
The Modified Barthel Index (MBI) was used to evaluate the activities of daily living of patients
Measured: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Motor evoked potential
TMS was used to detect the latency and amplitude of MEP of tibial anterior muscle and quadriceps femoris muscle on the affected and healthy sides, and to evaluate the cortical excitability of M1 area and the conduction function (conduction velocity and integrity) of corticospinal tract.
Measured: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Functional near-infrared spectroscopy imaging
Functional near-infrared spectroscopy (NIRS) was used to evaluate the brain function of the subjects in the resting state and task state (ankle dorsiflexion task), and to monitor the activation patterns of motor-related brain areas (such as primary motor cortex and supplementary motor area). The changes of functional connectivity of brain functional network were analyzed.
Measured: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2028 (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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Huizhou
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Pharmaceutical University
- Responsible party
- Principal investigator, Lvping Li, The Third People's Hospital of Huizhou
- Investigators
- Lvping Li, Master, Study director, The Third People's Hospital of Huizhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833423
- Sponsor's protocol ID
- 2026-KY-138-01
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Temporal Interference-based Deep Brain Stimulation Combined With Conventional Rehabilitation Training for Lower Limb Motor Dysfunction After Stroke: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07833423
- Acronym / sponsor ID
- 2026-KY-138-01
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Third People's Hospital of HuizhouUniversity, hospital or other
- Collaborators
- Guangdong Pharmaceutical University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 22 Sep 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.
Stroke, as one of the most disabling neurological diseases worldwide, causes significant functional impairments in the lower limbs, severely affecting the quality of life of patients. Traditional neuroregulation techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current/alternating current stimulation (tDCS/tACS) can only intervene in the cerebral cortex. Deep brain stimulation (DBS), which requires invasive craniotomy to implant electrodes and has certain risks, is difficult to fully meet the rehabilitation needs of patients. These treatment methods are insufficient. Transcranial Temporal Interference (TI) Stimulation, as a new non-invasive neuroregulation technology, generates low-frequency envelope signals through high-frequency electric fields to achieve precise stimulation of deep brain tissues, providing a new direction for the treatment of stroke. This study is a clinical research to explore the efficacy of TI technology in the treatment of lower limb dysfunction in stroke, aiming to expand the clinical practice of TI technology in the field of stroke rehabilitation and provide theoretical support and practical guidance for the transformation and application of TI technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation group | Sham comparator | Other: routine rehabilitation, Device: TI sham stimulationThe routine rehabilitation strictly follows the standard treatment protocols (SOC) recommended by domestic and international guidelines such as the "Chinese Guidelines for Stroke Rehabilitation Therapy", including secondary prevention with medication, task-oriented lower limb muscle strength training, balance training, gait correction training, and physical factor therapy. This is carried out by rehabilitation therapists according to the hospital's routine procedures, 5 times a week, each session lasting approximately 60 minutes, for a total of 3 weeks. The TI stimulation is a sham stimulation. Specifically, the electrode application, positioning, and equipment operation procedures are exactly the same as those in the true stimulation group. The current rises gradually from a 30-second slope to the preset intensity and then immediately returns to zero. Only the first 30 seconds produce a slight scalp sensation, and there is no effective modulated electric field thereafter. |
| True stimulation group | Experimental | Device: Transcranial Temporal Interference (TI) Stimulation, Other: routine rehabilitationThe conventional rehabilitation was the same as the sham stimulation group. On this basis, for the TI stimulation, the target area was selected as the affected side striatum (caudate nucleus), and a head model was constructed based on individualized cranial MRI (T1-weighted image). The NervioWeb and other online platforms were used to optimize the 8-12 electrode configuration scheme. Stimulation parameters: carrier frequency of 2 kHz and 2.020 kHz, generating a 20 Hz envelope; initial current intensity of 2 mA per electrode, gradually increasing to the tolerance limit (single electrode ≤ 5 mA, total current ≤ 10 mA); 20 minutes each time, 5 times a week, for a total of 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients met the diagnostic criteria of stroke formulated by the Fourth National Cerebrovascular Disease Conference and were confirmed by head CT or MRI.
- The duration of the first episode ranged from 1 to 6 months.
- Age ranged from 18 to 75 years and both sexes were included.
- There was definite lower limb dysfunction, and Brunnstrom stage of lower limbs was II-IV.
- Informed consent was obtained voluntarily.
Key exclusion criteria (9 listed)
- People with metallic implants (e.g., aneurysm clips, pacemakers) or skull defects.
- Have a history of epilepsy or are taking medications that may lower the seizure threshold.
- Patients with severe heart, liver, kidney dysfunction or other serious physical diseases.
- Pregnant or lactating women.
- Patients with skin allergy or skin lesions at irritating sites.
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 Temporal Interference (TI) StimulationThe stimulation target selected by TI was the contralateral striatum (caudate nucleus), and a head model was constructed based on individualized cranial MRI (T1-weighted image). The 8-12 electrode configuration scheme was optimized using online platforms such as NervioWeb. Stimulation parameters: carrier frequency of 2 kHz and 2.020 kHz, generating a 20 Hz envelope; initial current intensity of 2 mA per electrode, gradually increasing to the tolerated upper limit (single electrode ≤ 5 mA, total current ≤ 10 mA); 20 minutes each time, 5 times a week, for a total of 3 weeks. | Device | True stimulation group |
| routine rehabilitationThe routine rehabilitation strictly follows the standard treatment protocols recommended by domestic and international guidelines such as "Chinese Guidelines for Stroke Rehabilitation Therapy", including secondary prevention with medication, task-oriented lower limb muscle strength training, balance training, gait correction training, and physical factor therapy. This is carried out by rehabilitation therapists according to the hospital's routine procedures, 5 times a week, each session lasting approximately 60 minutes, for a total of 3 weeks. | Other | Sham stimulation group, True stimulation group |
| TI sham stimulationThe electrode application, positioning, and equipment operation procedures are exactly the same as those in the true stimulation group. The current gradually increases from a 30-second ramp to the preset intensity and then immediately returns to zero. Only the first 30 seconds cause a slight sensation on the scalp, and no effective modulated electric field is generated thereafter. 20 minutes each time, 5 times a week, for a total of 3 weeks. | Device | Sham stimulation group |
Primary outcome
Lower extremity part of Fugl-Meyer rating scale
Time frame: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
The Fugl-Meyer Assessment Lower Extremity component (FMA-LE) is a standardized tool for the assessment of lower limb motor function in patients after stroke. It contains 17 items and is divided into two subscales: lower limb motor and coordination/speed . Higher scores indicate better function. For each item, a score of 0 indicates unable to complete/no function, a score of 1 indicates partially completed/partially functional, and a score of 2 indicates fully completed/normal function.
5 secondary outcomes
Holden Functional grading assessment scale for walking
Time frame: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Berg Balance Scale
Time frame: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Modified Barthel Index
Time frame: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Motor evoked potential
Time frame: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
Functional near-infrared spectroscopy imaging
Time frame: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
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 22 Sep 2026.
- 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.
Lvping Li, Master study director
The Third People's Hospital of Huizhou
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Temporal Interference (TI) Stimulation and routine rehabilitation in people with Stroke, run by The Third People's Hospital of Huizhou.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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?
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 Lvping Li, Master (+86 13542799020, 4531027@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity part of Fugl-Meyer rating scale (time frame: Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).). 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 22 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.