Efficacy of Temporal Interference-based Deep Brain Stimulation Combined With Conventional Rehabilitation Training for Lower Limb Motor Dysfunction After Stroke

NCT07833423 | Not Yet Recruiting

• 1 other identifier: 2026-KY-138-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).

Study Arms (2)

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.

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.

Device: Transcranial Temporal Interference (TI) Stimulation; Other: routine rehabilitation

Interventions

Transcranial Temporal Interference (TI) Stimulation DEVICE

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.

True stimulation group

routine rehabilitation OTHER

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.

Sham stimulation group; True stimulation group

TI sham stimulation DEVICE

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.

Sham stimulation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• The Third People's Hospital of Huizhou: lead
• Guangdong Pharmaceutical University: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lvping Li, Master

  The Third People's Hospital of Huizhou

  STUDY DIRECTOR

Central Study Contacts

Lvping Li, Master

CONTACT

+86 13542799020; 4531027@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share