The Comparative Effects of Dual-tDCS and Anodal Premotor tDCS Over the Contralesional Hemisphere on the Upper Limb Function and Manual Dexterity in Patients With Chronic Stroke: Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks
研究概览
简要总结
Background: Transcranial direct current stimulation (tDCS) has been gaining increasing interest as a potential therapeutic tool to improve upper extremity (UE) rehabilitation outcomes following stroke. Within the concept of interhemispheric inhibition (IHI), most tDCS studies have applied anodal ipsilesional and/or cathodal contralesional primary motor cortex (M1) tDCS to rebalance IHI and enhance motor recovery. However, compelling evidence suggests that an excitation/inhibition model is oversimplified, and the role of both hemispheres in the encoding of information during motor learning should be acknowledged. Moreover, multiple lines of evidence have demonstrated the potential relevance of contralesional premotor cortex (PMC) for recovery after M1 injury.
Objective: We are aiming to investigate and compare the effects of two tDCS montages at different cortical sites (Dual-M1 vs. a-tDCS over contralesional PMC) by measuring the clinical outcomes of the most affected UE in patients with chronic subcortical stroke.
Methods: 35 participants will be randomly assigned to 1 of 3 groups (Group A received dual- M1 tDCS, Group B received a-tDCS over contralesional PMC, and Group C received sham stimulation). tDCS will be applied using intensity of 2 mA for 20 min. (5 times/week) for 2 consecutive weeks. Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) and Action Research Arm Test (ARAT) will be used to quantify the UE functional motor ability. Box and Block Test (BBT) will be used for gross manual dexterity and Nine Hole Peg Test (NHPT) will be used to measure fine hand dexterity. All measurements will be taken pre-treatment (T0) and post-treatment (T1) immediately after the 10th session, then 4 weeks after the end of stimulation period (T2) to assess the long-term effects.
Expected results: This study would verify whether enhancing the motor cortical hyperexcitability in the contralesional hemisphere has a beneficial on recovery of the paretic hand, or regaining the balance of transcallosal inhibitory circuits between the motor areas in both hemispheres has more positive effects on the motor outcomes . This study would also provide a predictive approach to enable realistic rehabilitation goal-setting by identifying the proper tDCS montage for patients with stroke depending on their impairment level.
详细描述
This experimental study will be conducted in a sham-controlled, single-blinded randomized controlled design. The subjects will be recruited - by convenience sampling - from the outpatient population of different governmental hospitals in Eastern Province of Saudi Arabia. Neurologists, Physiatrists and Physical therapists will be contacted to recruit potential subjects and IRB-approved letter will be sent to them. The subjects will be screened to determine whether a potential participant is eligible to be enrolled in the study or not. Only the principal investigator (PI) will conduct the screening procedures, which include reviewing medical record, in-person interview and administration of Mini-Mental State Examination. All screening activities will take 15-20 min., and they will be performed in a private screening room. Enrollment will occur after verifying the eligibility and obtaining the signed written consent form. Participants will be enrolled in the study only if they met all the inclusion criteria, which are:
- Male or Female participants aged ≥ 18
- First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
- Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE).
- Mini Mental State Examination Score ≥ 24.
All the participants were receiving conventional physical therapy and occupational therapy sessions (1-2 times/week).
The Exclusion Criteria included the following:
- History of epileptic seizures.
- Pre-stroke motor impairment(s) affecting UE.
- Presence of UE contractures or deformities.
- Botulinum toxin to UE muscles in the last 6 months.
- Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
- Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
- Use of CNS-affecting drugs.
- Additional neurological or psychiatric problem.
- Pregnancy.
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
- Single (Participant)
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
- •First ever, unilateral, ischemic, subcortical stroke in the territories supplied by the Middle Cerebral Artery (MCA) verified by brain imaging, at chronic stage (≥ 6 months).
- •Upper Extremity impairment verified by Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
- •Mini Mental State Examination Score ≥ 24
排除标准
- •History of epileptic seizures.
- •Pre-stroke motor impairment(s) affecting UE.
- •Presence of UE contractures or deformities.
- •Botulinum toxin to UE muscles in the last 6 months.
- •Presence of damaged skin on the scalp that would interfere with tDCS stimulation.
- •Individuals with metallic implant in the brain or medical devices (i.e., cardiac pacemaker, deep brain stimulator, cochlear implants).
- •Use of CNS-affecting drugs.
- •Additional neurological or psychiatric problem.
结局指标
主要结局
Change from Baseline 'Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)' at 4 weeks
时间窗: T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects
the most frequently used outcome measure when assessing UE function after stroke within the research context (Santisteban et al., 2016). We will exclude the 3 reflex items because they make no difference to the overall scores of the test (Gladstone, Danells and Black, 2002; Woodbury et al., 2007; Woytowicz et al., 2017). It is composed of 30 items, each scored on a scale of 0 to 2. It has an excellent overall reliability (Duncan, Propst and Nelson, 1983; Sanford et al., 1993), validity and responsiveness as an indicator of motor impairment severity across different stroke recovery time points (Platz et al., 2005; Hsieh et al., 2009).
次要结局
- Change from Baseline 'Action Research Arm Test (ARAT)' at 4 weeks(T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects)
- Change from Baseline 'Nine Hole Peg Test (NHPT)' at 4 weeks(T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects)
- Change from Baseline 'Box and Block Test (BBT)' at 4 weeks(T0: Baseline measurements (immediately prior stimulation), T1: Post-stimulation measurements (2 weeks after T0), T2: 4 weeks after T1 to evaluate the long-term effects)
研究者
Turki Abualait
Chair of Physical Therapy Department, Assistant Professor of Cognitive Neuroscience and Neurorehabilitation
Imam Abdulrahman Al Faisal Hospital