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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lvping Li, Master
- 電話番号：+86 13542799020
- メール：4531027@qq.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：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. |
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. 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. |
|
実験的：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. |
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. 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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Lower extremity part of Fugl-Meyer rating scale
時間枠：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. |
Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Holden Functional grading assessment scale for walking
時間枠：Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
|
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
時間枠：Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
|
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
時間枠：Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
|
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
時間枠：Measurements were conducted before the intervention (baseline), on the ninth day after the intervention, and again after the intervention (3 weeks later).
|
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
時間枠：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 (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).
|
協力者と研究者
捜査官
- スタディディレクター：Lvping Li, Master、The Third People's Hospital of Huizhou
研究記録日
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研究開始 (推定)
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研究の完了 (推定)
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