Comparison Between the Effect of Unihemispheric and Bihemispheric Transcranial Direct Current Stimulation on Spasticity and Motor Outcome in Subacute Ischemic Stroke Patients: as Add on Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Brain-Derived Neurotrophic Factor (BDNF) concentration
研究概览
简要总结
This is a randomized clinical trial to study the effect of tDCS in participants with subacute ischemic stroke, the study participants will be randomly assigned into three groups; bihemispheric, unihemispheric and sham group.
详细描述
Despite the central origin of stroke affecting the primary motor cortex M1, majority of the rehabilitative techniques of physical therapy and occupational therapy practice depending peripheral methods for gaining motor functions. There is a great need to develop methods in order to improve the outcome of physical or medical rehabilitation and enhance long-term functional outcome. Many researches' work over the past several years have inspected the use of transcranial direct current stimulation (tDCS) to promote the advantageous effect of neurological rehabilitation.
The aim of This study Is to compare between the effect of unihemispheric and bihemispheric tDCS on the motor outcome, and spasticity in sub-acute ischemic stroke patients.
Thirty sub-acute ischemic stroke patients participated in the study, randomly assigned to one of three groups-tDCS bihemispheric or unihemispheric or sham group. Those patients had stroke in the last 3 months at maximum with NIH stroke score less than 25. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS used in the clinical study to deliver noninvasive brain stimulation, consisted of 20 minutes of 2 mA in each session for twelve sessions three sessions per week. All participants received physiotherapy and rehabilitation therapy was tailored to meet all patients' deficits, and lasted a total of 45 minutes per day, 3 days per week for four weeks.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor) To make sure that no bias should enter the assessment of the results, neither the patient nor the external assessor will be aware whether active tDCS will be applicated to a particular case. The patients don't know if which group they are participated in, bihemispheric, unihemispheric, of sham group, external assessor was recruited to assess patients after the intervention ended.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those patients had stroke in the last 3-6 months.
- •Subcortical stroke of middle cerebral artery (MCA), caused unilateral hemiplegia.
- •National institute of health stroke scale (NIHSS) motor deficits section with score 2 to 15.
排除标准
- •Patient with second onset of stroke or history of Transient ischemic attack (TIA)
- •Metallic Implant or heart pacemakers.
- •Primary cerebral or subarachnoid hemorrhagic stroke.
- •Seizure or epilepsy or history of epilepsy at the family.
- •Intracranial abscess or brain tumor.
- •Cardiovascular disease myocardial infarction, heart failure (unstable cardiac status).
- •Atrial Fibrillation or paroxysmal AF in the last 30 days.
- •Congenital heart diseases.
- •Presence of any other neurological or psychiatric disorder.
- •Cognitive/consciousness disorders.
- •Oher conditions should be excluded (e.g. tumor, cancer, rheumatologic, Lung disease related to infection, renal/ hepatic diseases, deep venous thrombosis and autoimmune diseases).
- •Speech disorders (Dysarthria & Aphasia).
- •NIH Stroke score above 25, will be excluded.
- •Patients who underwent thrombolytic therapy or any vascular interventions.
研究组 & 干预措施
Bihemispheric Stimulation Group
The first group tDCS bihemispheric stimulation consisted of 20 minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex M1 (C3 and C4 of the international 10 -20 EEG electrode system).
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
Unihemispheric Stimulation Group
The second group unilateral stimulation, the anode placed over the ipsilesional motor cortex M1 (C3 or C4 of the international 10 -20 EEG electrode system) and the cathode over contralesional supraorbital bone.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
Sham Group
The third sham group, the anode placed over the ipsilesional motor cortex M1 (C3 or C4 of the international 10 -20 EEG electrode system) and the cathode over contralesional supraorbital bone, but delivering no current.
干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
Brain-Derived Neurotrophic Factor (BDNF) concentration
时间窗: 1 Month
is assessed pre and post-treatment for all of the participants using (ELISA) molecular test, the difference between pre and post-treatment will be only assessed, no normal range is quantified.
Fugl-Meyer Assessment (FMA)
时间窗: 1 Month
To assess the upper and lower extremities, motor and sensory recovery assessment. Maximal attainable score is 226, means a good and functional physical state.
Modified Ashworth Scale (MAS)
时间窗: 1 Month
To assess the spasticity within the upper and lower extremities, score ranges from 0-4 with 5 choices. 0 indicates no resistance and 4 indicates rigidity. Higher scores indicate worse outcome.
次要结局
- The National Institutes of Health Stroke Scale, NIH Stroke Scale (NIHSS)(Assessed for one time during participant recruitment)
- Berg Balance Scale(1 Month)