Enhancement of Rehabilitative Treatment-Dependent Functional Recovery After Stroke by Transcranial Direct Current Stimulation (tDCS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
研究概览
简要总结
This study will examine whether brain stimulation using transcranial direct current stimulation (tDCS) in stroke patients undergoing rehabilitation therapy can help patients recover strength and motor function more than rehabilitation therapy alone. For tDCS, two small metal disks (electrodes) attached to wires are placed on small cotton pads and taped to the subject's head, one on the forehead above the eye and the other on the top of the head. The electrodes deliver a brief electrical current that stimulates the cortex, the part of the brain responsible for motor function.
Adult patients who have weakness on one side of their body as a result of a stroke occurred within the last 15 days may be eligible for this study. NIH is not directly recruiting patients for this study. Patients will be selected through the National Rehabilitation Hospital (NRH) Research Center personnel in Washington, DC, from patients under treatment at that facilitiy. Candidates are screened with a physical and neurologic examination, a review of tests done on admission to NRH, and a magnetic resonance imaging (MRI) scan, if one has not been done since the stroke. MRI uses a strong magnetic field and radio waves to obtain images of the brain. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the patient lies on a table that can slide in and out of the cylinder. Scanning time for this study takes about 30 to 45 minutes.
Participants are randomly assigned to receive tDCS or placebo stimulation, along with rehabilitation therapy, for 2 to 3 weeks, depending on the patient's length of stay at the NRH. For the placebo stimulation, electrodes are placed on the patient's scalp as with tDCS, but no current is delivered. Before and after each rehabilitation session with electrodes, patients undergo Jebsen Taylor motor testing, in which they are asked to lift small objects, turn cards, use a spoon, stack checkers, and lift cans as fast as they can.
On the day of discharge, patients have physical and neurological examinations and the motor function tests described below. The motor tests are repeated, along with standard care and a review of their health status, during outpatient follow-up visits scheduled at 3, and 12 months. The motor tests are:
- Wolf motor function test - Patients are asked to raise a forearm on a table, on a box, to reach across a table, push a sandbag, place a hand on the table, pull a weight, lift a can, pick up a pencil, pick up a paper clip, stack checkers, flip cards, use a key, fold a towel, and pick up a basket.
- Barthel index - Patients are timed for the speed with which they perform certain tasks, such as feeding, grooming, or moving a wheelchair.
- Abilhand questionnaire - Patients answer questions about how they perform routine daily activities.
- GOT test of tactile discrimination - Patients describe objects they feel with their hand.
- Ashworth spasticity scale - A medical staff person moves the patient's arm back and forth to see how stiff it is.
详细描述
OBJECTIVES
There is no universally accepted strategy to promote recovery of motor function after stroke, the main cause of long-term disability among adults. Neurorehabilitation contributes to recovery during the first days to weeks after stroke and later decelerates. Therefore, it is desirable to develop strategies to enhance rehabilitative effects on motor recovery particularly in the early phase after stroke in this patient group. We have recently demonstrated that cortical stimulation in the form of TMS enhances the beneficial effects of motor training and cortical plasticity in healthy volunteers and that tDCS (another noninvasive more comfortable stimulating technique than TMS transiently improves functional motor skills of the paretic hand of chronic stroke patients in the absence of training. Given the paucity of strategies available to enhance neurorehabilitation after stroke, it is now crucial to determine if tDCS can enhance the beneficial effects of customarily used rehabilitative treatment. tDCS has been used in several hundred subjects worldwide and in approximately 9 stroke patients, 15 Parkinson's disease patients and 15 healthy volunteers in our lab in the absence of undesirable side effects.
In addition to the above objectives, we will also apply functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) techniques to determine the extent of changes in neural responses and functional shift in cortical representations/reorganization as a result of the proposed intervention strategies. fMRI as a measure is important in understanding changes in brain activation prior to, during, and after motor recovery and the effects of tDCS and the rehabilitative treatment strategies under investigation. Integrating TMS together with fMRI studies will provide crucial information on the functional role of brain regions activated in neuroimaging studies in association with functional recovery.
STUDY POPULATION
We plan to study 120 patients with a single cortical or subcortical subacute stroke. Thirty healthy volunteers and a sub-group of 30 patients from the 120 patient population will also be recruited in the fMRI and TMS part of the study. The reason for including 30 patients in the fMRI and TMS components of the study is that it is anticipated that not all the 120 patients recruited in the initial study (i.e., the tDCS and therapeutic intervention phase) may be able to perform the tasks required for the fMRI part of the study and also satisfy the Exclusion criteria for fMRI scans. In addition, based on previous studies and preliminary fMRI power analysis, we estimate that 30 patients is likely to be sufficient to provide a representative sample of the patient group for the testing of the hypotheses stated in the protocol. Thirty healthy volunteers are necessary for the fMRI and TMS components of the study in order to obtain normative data for the TMS and fMRI components of the investigation. They will have the multiple number of TMS and fMRI sessions as patients in order to obtain descriptive information on the variability of these measures in both groups.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
