The Effects of Bilateral-Transcranial Electrical Stimulation (tES) on Cortical Activity, Motor Performances, and Cognitive Function in Sub-Acute and Chronic Stroke Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (FMA) of upper and lower extremities
研究概览
简要总结
The present study will use transcranial electrical stimulation (tES) with conventional physical therapy in sub-acute (at least 2 weeks after stroke onset) to chronic stroke within 2 years to investigate the effect on cortical activity and upper and lower limb motor function. The findings may support the usage of tES for improving brain activity and motor function in a clinic setting.
详细描述
Stroke is a leading cause of death and disability in the world. The prevalence of stroke is high in developing countries; for example in Thailand, stroke is one of a leading cause of death and disability. The estimate prevalence among adults aged 45 years and older is 1.88%, and the mortal rate of stroke is still has continued to increase over the past 5 years. Globally, 87 percent of stroke people have suffered from ischemic stroke while 13% suffered from hemorrhagic stroke. Fifty-seven percent stroke cases remains disability reported by the world stroke organization. Motor impairment is a major limit post-stroke and it affects activities in daily life. Cognitive impairments (i.e., executive function, attention, and memory) are commonly observed in post-stroke survivors which may lead decrease in functional capacity and affects the efficacy of rehabilitation in stroke.
Stroke is defined as a sudden neurological explosion caused by impaired perfusion through the blood vessels to the brain. Ischemic stroke is caused by deficient blood flow and oxygen supply to the brain, while, hemorrhagic stroke is caused by bleeding or leaky blood vessels, resulting in cell death. After-stroke, cortical excitability decreases in the ipsilesional hemisphere and increases in the contralesional hemisphere. Consequently, there is an imbalance in the interhemispheric inhibition (IHI) between both hemispheres. The onset of IHI imbalance in stroke patients remains unclear, although the occurrence of motor impairment since the onset. However, the IHI imbalance is remained throughout stroke life. The imbalance of IHI was found to be negatively correlated with stroke motor recovery; a greater imbalance was associated with a poorer motor performance. IHI imbalance is not a cause of poor motor recovery, but instead might be the consequence of underlying recovery processes.
An electroencephalography (EEG) is the non-invasive measurement tool with high temporal resolution, which can detect a summary of the postsynaptic electrical signals of pyramidal neurons in the cortical layers. EEG is a useful measurement after stroke. Several metrics have been found to be related to recovery across all stroke phases. A recent review in 2022 reported that brain symmetry index (BSI) and spectral power are the most efficacious metrics to use to predict stroke recovery. BSI is one of the more popular EEG-derived parameters use to quantify the mean spectral asymmetry between the two hemispheres. It has a normal range of 0 to 1, where 0 indicates perfect symmetry, while 1 indicates maximal asymmetry. BSI was significantly higher in stroke patients indicating brain asymmetry compared with healthy controls Van Putten and Tavy demonstrated in acute ischemic stroke people that BSI was unchanged within 24 hours post-stroke, however it had a positive correlation between the National Institutes of Health Stroke Scale (NIHSS); a higher impairment, a higher brain asymmetry. It was reported that higher BSI value in the acute to sub-acute phase were associated with lower motor performance in 4 weeks later implying that BSI could possibly aid in prognostication of motor outcome during stroke recovery phase. Moreover, spectral power analysis in stroke individuals showed fluctuation of brain oscillation caused by cell death such as an increase of low frequency power (delta and theta) in the ipsilesional hemisphere that occurred as early as one minute after stroke, whereas high frequency power (alpha and beta) were decreased. An increase in delta activity post-stroke was also negatively corelated to cognitive functioning. Cortical activity in recovery phase can represent motor recovery and cognitive function post-stroke. An increase of high-frequency brain wave (i.e. beta band) is related to improve motor recovery in subacute and chronic phases of stroke. In addition, increase of alpha band and decrease of delta band correlated with improve cognitive function in stroke survivors.
Motor recovery post-stroke rapidly increase within first 3 months (acute to early subacute phase) and less significant recovery subsequently in late-subacute (3-6 months), then, spontaneous recovery is leading to a stable at its limit in chronic phase (>6 months), but the recovery can expand up to 2 years post-stroke after receiving rehabilitation. Therefore, the rehabilitation can enhance stroke recovery beyond spontaneous recovery in the subacute and chronic phases. There are 2 factors influencing stroke recovery: 1) intrinsic factors which are age, sex, stroke onset, stroke type, severity, co-morbidities, socioeconomic status, and genetic profiles, 2) extrinsic factors such as caregiver support, pharmacology, and rehabilitation program in which consists of bottom-up and top-down approaches. Rehabilitation post-stroke is recommended to enhance recovery and reduce long-term disability. The guideline of American Stroke Association (ASA) has recommended that patients with stroke required therapeutic intervention of at least 3 times per week for 20-60 min per session.
Non-invasive brain stimulation (NIBS) i.e., transcranial Electrical stimulation (tES) is a top-down approach that has been recommended to use as an add-on intervention in rehabilitation post-stroke. The most common tES techniques used in research are 1) transcranial Direct Current Stimulation (tDCS) and 2) transcranial Alternating Current Stimulation (tACS). The difference between these two tES techniques is the current forms elicited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Stroke individuals aged 18 - 80 years.
- •A first-ever unilateral ischemic or hemorrhagic stroke.
- •Stroke onset from at least 2 weeks - 2 years.
- •Having modified Rankin scale (mRS) 1-4
- •Ability to communicate, follow, and understand the instruction.
排除标准
- •Presence of any neurological antecedent, unstable medical conditions or condition that may increase risk of stimulation such as epilepsy and seizure, and history of brain surgery.
- •Presence of metal implantation, intracranial shunt, cochlear implantation, or cardiac pacemakers.
- •Presence of opened wound or infectious wound around the scalp.
- •Moderate pain in any joint of the upper or lower paretic limb (numerical pain rating score > 4/10).
- •History of receiving non-invasive brain stimulation within the past 6 months.
研究组 & 干预措施
Active tDCS and conventional physical therapy program
Participants will receive Active tDCS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
干预措施: transcranial direct current stimulation (Active) (Device)
Active tDCS and conventional physical therapy program
Participants will receive Active tDCS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
干预措施: Conventional physical therapy program (Other)
Active tACS and conventional physical therapy program
Participants will receive Active tACS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
干预措施: transcranial alternating current stimulation (active) (Device)
Active tACS and conventional physical therapy program
Participants will receive Active tACS for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
干预措施: Conventional physical therapy program (Other)
Sham stimulation and conventional physical therapy program
Participants will receive sham stimulation for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
干预措施: transcranial electrical stimulation (sham) (Device)
Sham stimulation and conventional physical therapy program
Participants will receive sham stimulation for 30 minutes prior conventional physical therapy program. They will be asked to perform this combination therapy for 15 sessions, occurring three times a week for five weeks.
干预措施: Conventional physical therapy program (Other)
结局指标
主要结局
Fugl-Meyer Assessment (FMA) of upper and lower extremities
时间窗: Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention
The Fugl-Meyer Assessmen is used to quantify motor impairment and recovery post-stroke. The participants will use their unaffected side to perform first, and then subsequently perform their affected side in each movement 3 times. The best movement will be scored. The best performance was scored through direct observation as follows: 0=could not perform, 1= performed partially, and 2= performed fully. There was a total score of 100 (66 and 34 points for the upper and lower limbs, respectively
次要结局
- Timed Up and Go test(Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention)
- Five-Time Sit to Stand Test(Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention)
- Montreal Cognitive Assessment(Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention)
- Spatiotemporal gait variables(Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention)
- Brain symmetry index (BSI)(Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention)
- Absolute power(Baseline, post-intervention at week 5, 1-month and 3-month after post-intervention)
