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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: routine rehabilitation; Device: TI sham stimulation; Device: Transcranial Temporal Interference (TI) Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lvping Li, Master; Phone Number: +86 13542799020; Email: 4531027@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham stimulation group; 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; 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.; Device: TI sham stimulation; 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.
Experimental: True stimulation group; 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.	Other: routine rehabilitation; 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.; Device: Transcranial Temporal Interference (TI) Stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Third People's Hospital of Huizhou
• Collaborators: Guangdong Pharmaceutical University
• Investigators: Study Director: Lvping Li, Master, The Third People's Hospital of Huizhou

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 22, 2026

Study Record Updates

• Last Update Posted (Actual): September 22, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2026-KY-138-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No