Neuroplasticity Following Bihemispheric Transcranial Direct Current Stimulation and Motor Training in Chronic Stroke Patients.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Treatment-related changes in functional magnetic resonance imaging
研究概览
简要总结
Functional and structural magnetic resonance imaging (MRI) will be used to investigate neural correlates of bihemispheric transcranial direct current stimulation (tDCS) associated with upper limb rehabilitation in chronic stroke patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individualized rehabilitation. Neuroimage will be employed before and after the intervention to investigate neural correlates of expected changes in motor function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Stroke (> 12 months)
- •Upper limb sensorimotor sequelae due to stroke affecting only one cerebral hemisphere
- •The structural integrity of the corpus callosum sensorimotor
- •Showing ability to perform some movement with the paretic upper limb: at least minimal active mobility of the wrist and two fingers of the paretic hand.
- •Score ≥ 18 at Folstein Mini-Mental State Examination
排除标准
- •Score ≥ 4 at Ashworth Scale
- •MRI or tDCS contraindications (cardiac pacemakers; implanted medication pumps; cochlear, or eye implants; craniotomy, skin lesions at the site of stimulation; surgical clips in or near the brain; claustrophobia, history of seizures, permanent makeup or tattoos with metallic dyes…)
- •Prior neurological diseases
- •Hemodynamic instability
- •Pregnancy
- •Traumatic or orthopedic lesion limiting the range of upper limb motion
- •Severe comprehension deficits, apraxia or neglect that would interfere with performing the study tasks
- •Score > 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke
结局指标
主要结局
Treatment-related changes in functional magnetic resonance imaging
时间窗: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
Brain functional changes from baseline to post-treatment
Treatment-related changes in white matter
时间窗: pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment)
Brain structural (white matter) changes from baseline to post-treatment
次要结局
- Changes in Jebsen-Taylor Hand Function Test scores(pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days)
- Changes in Stroke Impact Scale scores(pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment), follow-up 30 days, follow-up 90 days)
- Changes in Fugl-Meyer assessment of paretic upper limb motor function(pre-treatment (baseline), post-treatment (from 3 to 7 days after the end of the treatment); 30 days follow up (30 days after completing treatment) and 90 days follow up (90 days after completing treatment))