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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Lower extremity part of Fugl-Meyer rating scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: routine rehabilitation (Other)
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.
干预措施: TI sham stimulation (Device)
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.
干预措施: Transcranial Temporal Interference (TI) Stimulation (Device)
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.
干预措施: routine rehabilitation (Other)
结局指标
主要结局
Lower extremity part of Fugl-Meyer rating scale
时间窗: 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.
次要结局
- 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).)
研究者
Lvping Li
Associate Chief Physician
The Third People's Hospital of Huizhou