Clinical Effects of Immersive Multimodal BCI-VR Training After Bilateral Stimulation With rTMS on Upper Limb Motor Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Dynamometry
研究概览
简要总结
An immersive multimodal BCI-VR training and bilateral rTMS protocols are likely to complement their effects achieving a stronger neuroplasticity enhancement in stroke patients. Both have been used separately for the treatment of motor sequelae in the upper limbs after stroke. The main objective of this study is to carry out a double-blind, randomized, controlled trial aiming to study the clinical effect of Neurow system (NeuroRehabLab, Lisbon, Portugal) over bilateral rTMS plus conventional rehabilitation in upper limb motor sequelae after subacute stroke (3 to 12 months). We will look for changes in 1. Isometric strength in upper limb, 2. Functional motor scales of upper limb, 3. Hand dexterity 4. Cortical excitability changes. The investigators in the present project hypothesize that both neuromodulation techniques combined will be superior to the use of rTMS alone as adjuvant therapy to conventional rehabilitation.
详细描述
Stroke is a leading cause of long-term disability, it reduces mobility in more than half of stroke survivors age 65 and over.
Despite the lack of objective prognostic factors regarding the patient´s functionality after a stroke, we know that age, the level of initial disability, and the location and size of the lesion are elements that affect the evolution of post-stroke rehabilitation.
After stroke, the recovery of lost functions in the brain is achieved thanks to reorganizing networks in a process known as plasticity. Some damaged brain tissue may recover, or undamaged areas take over some functions.
One of the most relevant aspects of the rehabilitation prognosis is the time of evolution. After stroke, improvement is noticeably reduced over the second month, finding stabilization around the sixth month. One of the reasons for this is the reduction of neuroplasticity. There are indicative studies that reflect that, six months after a stroke, more than 60% of subjects will have a non-functional hand for Basic Activities of Daily Living (BADL), and 20-25% will not be able to walk without assistance. This determines the important global burden that stroke represents. It is relevant to emphasize the degree of disability after the rehabilitation process will be determined by the combination of existing motor, sensory and neuropsychological deficiencies.
In the last years, several non-invasive neuromodulation techniques have been shown efficient to enhance plasticity and stroke recovery. Among these interventions we can find exogenous neuromodulation, meaning that the neuromodulator stimulus comes from an external source, as is the case with rTMS (repetitive transcranial magnetic stimulation) which has the capacity to change the cortical excitability depending on the frequency of the magnetic pulses. Low frequencies (≤ 1 Hz) reduce local neural activity and high frequencies (≥ 5 Hz) increase cortical excitability. This technique has been successfully used bilaterally, stimulating the injured hemisphere and inhibiting the healthy one, to treat the interhemispheric inhibition phenomenon in stroke patients as it influences stroke recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Older than 18 years old.
- •Ischemic or hemorrhagic cerebrovascular injury diagnosed by a neurologist and who have at least one brain-imaging test.
- •The onset of hemispheric ischemic or hemorrhagic stroke> 3 months.
- •Presence of upper limb motor sequelae due to stroke.
- •Sufficient cognitive ability to understand and perform tasks: Token Test>
- •Stability in antispastic medication for more than 5 days.
- •Able to read and write.
排除标准
- •History of seizure or brain
- •Pacemakers, medication pumps, metal implants in the head (except dental implants)
- •Clinical unstability
- •Other pre-existing neurological diseases or previous cerebrovascular accidents with sequelae.
- •Sensory aphasia
- •Previous TMS after stroke
- •Hemispatial neglect,
- •Flaccid paralysis Brunnstrom's stage < 1
- •Visual problems
结局指标
主要结局
Change in Dynamometry
时间窗: From Baseline at 6 weeks
A handheld analogic dynamometer (Jamar® Plus+ Hand Dynamometer, 0-90 kg) will be used to assess isometric grip strength. Patients will be positioned in a straight back chair with both feet on the floor and the forearm resting on a stable surface. Each patient will be instructed to assume a position of adducted and neutrally rotated shoulder. For the arm to be tested, the elbow was flexed to 90º, the forearm and wrist will be in neutral positions, and the fingers will be flexed as needed for a maximal contraction. Patients will perform a maximal isometric grip contraction until they reach maximal force output. Three measures will be taken with 1-minute rest between test, and the mean value will be recorded
Change in Motricity Index of the Arm
时间窗: From Baseline at 6 weeks
The upper limb section of the MI assesses muscle strength in 3 muscle groups, including grip, elbow flexion, and shoulder separation. Each movement is scored discreetly (0 if there is no movement, 9 if the movement is palpable, 14 if the movement is visible, 19 if the movement is against gravity, 25 if the movement is against resistance and 33 if the movement is normal ), obtaining a total score for the upper limb that ranges from 0 (severely affected) to 100 (normal). This assessment methodology has been widely used in rehabilitation progress evaluation and counts with a normalized and weighted scoring system.
Change in Fugl-Meyer Assessment for upper extremity score
时间窗: From Baseline at 6 weeks
It is an observational rating scale that assesses sensorimotor impairments in post-stroke patients. It also includes four subscales: A. Upper Extremity (0-36), B. Wrist (0-10), C. Hand (0-14), D. Coordination/Speed (0-6) composing a total maximum score of 66 points. The therapist will rate each item according to direct observation of the motor performance, using a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, and 2 = performs fully) with lower scores indicating more impairments. The FMA is easy to use and has excellent validity, reliability, and responsiveness.
Change in Stroke Impact Scale score
时间窗: From Baseline at 6 weeks
It is a stroke-specific quality of life instrument to assess the consequences of stroke and to determine the quality of life improvement after stroke rehabilitation. It presents 4 subscales, but only hand function domain will be evaluated. Lower scores indicate more impairment in quality of life. The Minimal Detectable Change (MDC) and Clinically Important Difference (CID) of the hand function subscale are 25.9 and 17.8 points, respectively.
次要结局
- Change in TMS Resting Motor Threshold (RMT) and cortical silent period (CSP)(From Baseline at 6 weeks)
- Change in Finger Tapping Task(From Baseline at 6 weeks)
- Change in Electroencephalogram data(At 6 weeks from Baseline)
- Change in Nine Hole Peg Test(From Baseline at 6 weeks)
- Change in TMS Resting Motor Threshold (RMT)and cortical silent period (CSP)(From Baseline at 4 weeks)
- Change in Barthel Index(BI)(From Baseline at 6 weeks)
- Change in Nottingham Sensory Assessment (NSA)(From Baseline at 6 weeks)
- Change in Modified Ashworth Scale score(Baseline at 6 weeks)