Effect of Transcranial Alternating Current Stimulation on the Recovery of Motor Control of the Upper Limb and Cerebral Connectivity in Chronic-stage Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in EEG spectral power in Beta band follow up
研究概览
简要总结
This project seeks to evaluate the effect of transcranial alternating current stimulation (tACS) on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14-sessions (5-week) rehabilitation program for adult patients with diagnosis of stroke at chronic stage. Specifically, the stimulation on Gamma ranges, because the evidence available so far allows us to propose that the tACS in the Gamma range (around 70 Hz) facilitates motor execution.
For this purpose, the experimental approach involves active (70 Hz in Gamma rhythm and 7 Hz, Theta rhythm) and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design.
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
Using specific motor control parameters, clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
详细描述
This project seeks to evaluate the effect of transcranial alternating current stimulation (tACS) on the recovery of motor control of the upper limb and associated neuronal synchrony during a 14 sessions (5 week) rehabilitation program for adult patients with diagnosis of stroke at chronic stage. Specifically, the stimulation on Gamma ranges, because the evidence available so far allows us to propose that the tACS in the Gamma range (around 70 Hz) facilitates motor execution. For this purpose, the experimental approach involves active (70 Hz in Gamma rhythm and 7 Hz, Theta rhythm) and sham tACS together with an analytical and integrated motor training with a double-blind and randomized design.
Our hypothesis is that Gamma frequency tACS restores neuronal synchrony in Beta range, which enhances the upper limb motor recovery associated with a training program.
The general objective is to assess the effects of a combined program of tACS and upper limb training on motor performance and brain connectivity in chronic-stage stroke patients.
The specifics objectives to accomplish this are (1) Implement a system for simultaneous measurement of motor activity and EEG under tACS, considering possible postural alterations in stroke patients. (2) Evaluate the upper limb motor control and neuronal synchrony associated with motor performance during the execution of a combined stimulation and training program. Training will include analytical and functional tasks to optimize the performance in function and activity ICF level. tACS will be applied only during analytical task. (3) Analyze the changes in motor performance and neuronal synchrony for the experimental groups.
Using specific motor control parameters (kinetic and kinematic control), clinical scales and electroencephalography, the immediate and long-term (3 months after finished the training) behavioral and neurophysiological effect of this new neurostimulation paradigm (tACS plus training) for motor rehabilitation of stroke will be established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Neither the participant or the professionals that will make the training and the assessments will know to which group the participants was assigned.
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
- 否
入选标准
- •Diagnosis of unilateral stroke at chronic stage (6 months or more)
- •Upper Extremity -Fugl Meyer > 10
- •Wrist extensors strength of the paretic limb of 2 or more in the Medical Research Council (MRC) scale
- •Active shoulder movement (flexion or abduction) of 30º or more
- •Be able to follow the instructions necessary to achieve the training protocol
排除标准
- •Have a cerebellar stroke or ataxia
- •Have some medical condition contraindicated for tACS (epilepsy, pacemaker, prosthesis between others)
- •Have post-stroke epilepsy
- •Limited passive range of motion in the elbow (less than 45º in flexo-extension plane)
- •Limited passive range of motion in the wrist (less than 40º in flexo-extension plane)
- •Limited passive range of motion in the shoulder (less than 70º in flexo-extension plane)
- •Have another neurological condition that leads to upper extremity sequelae
- •Have a normal performance in the clinical test
结局指标
主要结局
Change in EEG spectral power in Beta band follow up
时间窗: week 12
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
Change of Impairment Measure post-intervention: Upper Extremity Fugl Meyer
时间窗: week 5 or 6 (end of the training program)
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
Change of Impairment Measure follow up: Upper Extremity Fugl Meyer
时间窗: week 12
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
Impairment Measure pre-intervention: Upper Extremity Fugl Meyer
时间窗: week 0
Scale use to assess motor impairments (ICF function level), and adequately reflects the analytical motor control of force and direction of movement. The scale has a maximum of 66 points, which indicates a normal performance. Lower scores indicate worse performance.
EEG spectral power in Beta band pre-intervention
时间窗: week 0
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
Change in EEG spectral power in Beta band post-intervention
时间窗: week 5 or 6 (end of the training program)
Change in spectral power in the Beta band (13-30Hz) associated with motor performance in kinetic and kinematic tasks
次要结局
- Performance measure in the trained kinetic task (behavioral parameter)(week 0, week 5 or 6 (end of the training program) and week 12)
- Activity Measure: Action Research Arm Test(week 0, week 5 or 6 (end of the training program) and week 12)
- Change in Activity Measure post-intervention: Action Research Arm Test(week 5 or 6 (end of the training program))
- Change in Activity Measure follow up: Action Research Arm Test(week 12)
- Change in the performance measure in the trained kinetic task at follow up (behavioral parameter)(week 12)
- Change in the performance measure in the trained kinetic task post-intertenvion (behavioral parameter)(week 5 or 6 (end of the training program))
- Performance measure in trained kinematic task (behavioral parameter)(week 0, week 5 or 6 (end of the training program) and week 12)
- Change in the performance measure in the trained kinematic task post-intervention (behavioral parameter)(week 5 or 6 (end of the training program))
- Change in performance measure in the trained kinematic task at follow up (behavioral parameter)(week 12)
研究者
Juan Jose Mariman Rivero
Full professor
Universidad Metropolitana de Ciencias de la Educacion