Innovative Therapy Combining Neck Muscle Vibration and Transcranial Direct Current Stimulation in Association With Conventional Rehabilitation in Left Unilateral Spatial Neglect Patients: HEMISTIM Protocol
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Catherine Bergego Scale
研究概览
简要总结
BACKGROUND: Unilateral spatial neglect (USN) rehabilitation remains a challenge and requires the development of new methods that can be easily integrated into conventional practice. The aim of the HEMISTIM protocol is to assess immediate and long-term functional outcomes and neuropsychological aspects of recovery, induced by an innovative association of left-side neck-muscle vibration (NMV) and anodal transcranial Direct Current Stimulation (tDCS) on the ipsilesional posterior parietal cortex during occupational therapy sessions in patients with left USN.
METHODS: Participants will be randomly assigned to 4 groups: control, Left-NMV, Left-NMV + sham-tDCS or Left-NMV + anodal-tDCS. NMV will be applied during the first 15 minutes of occupational therapy and tDCS will be applied for 20 minutes, starting 5 minutes before, three days a week for three weeks. USN will be assessed at baseline, just at the end of the first experimental session, after the first and third weeks of the protocol and three weeks after its ending.
DISCUSSION: Left NMV, by activating multisensory integration neuronal networks, might enhance beneficial effects obtained by conventional occupational therapy sessions since interesting post-effects were shown when it was combined with voluntary upper limb movements. The investigators expect to reinforce lasting intermodal recalibration through LTP-like plasticity induced by anodal tDCS. The HEMISTIM protocol represents a therapeutic innovation associated to conventional practice that could provide a partial solution to the rehabilitation challenges of the USN syndrome and some insights to its underlying mechanisms.
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
- Double (Investigator, Outcomes Assessor)
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
- •admitted in a post-stroke rehabilitation unit in the sub-acute phase (15 days to 6 months from the onset of stroke symptoms)
- •at least 18 years old
- •a first unilateral right hemispheric stroke
- •diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
- •Behavioral Inattention Test (c-BIT), inferior or equal to 129
排除标准
- •unable to give informed consent
- •pregnant women
- •patients with skin lesions on the areas for electrode placement
- •having history of metal-in-cranial injury
- •vestibulo-cochlear illness
- •cardiac pacemaker
研究组 & 干预措施
Control patients
Patient receiving no additional treatment to conventional occupational therapy sessions
left-NMV
Patient will be equipped with vibratory stimulators during conventional occupational therapy sessions.
Only the left-side NMV vibrator will be activated.
干预措施: Neck muscle vibration (Device)
left-NMV + sham-tDCS
Patient will be equipped with vibratory stimulators and with electrodes form sham-tDCS during conventional occupational therapy sessions.
Only the left-side NMV vibrator will be activated.
干预措施: Neck muscle vibration + sham-tDCS (Device)
left-NMV + anodal-tDCS
Patient will be equipped with vibratory stimulators and with electrodes for tDCS during conventional occupational therapy sessions.
Only the left-side NMV vibrator will be activated.
干预措施: Neck muscle vibration + anodal-tDCS (Device)
结局指标
主要结局
Catherine Bergego Scale
时间窗: 3 weeks after the last session of intervention
Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
Catherine Bergego Scale
时间窗: at the end of the first week of inclusion
Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
Catherine Bergego Scale
时间窗: Immediately following first session of occupational therapy.
Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
Catherine Bergego Scale
时间窗: after the first week of protocol
Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
Catherine Bergego Scale
时间窗: after the third week of protocol
Functional scale assessing unilateral spatial neglect severity in daily life situations. This is a score on 30. The higher the score, the severe the unilateral spatial neglect
次要结局
- Fluff test(3 weeks after the last session of intervention)
- The Map of France test(3 weeks after the last session of intervention)
- The Subjective Straight-Ahead test(3 weeks after the last session of intervention)
- The Wheelchair navigation test(3 weeks after the last session of intervention)
- Gainotti's drawing copying test(3 weeks after the last session of intervention)
- Fluff test(at the end of the first week of inclusion)
- Fluff test(Immediately following first session of occupational therapy.)
- Fluff test(after the first week of protocol)
- Fluff test(after the third week of protocol)
- Gainotti's drawing copying test(at the end of the first week of inclusion)
- Gainotti's drawing copying test(Immediately following first session of occupational therapy.)
- Gainotti's drawing copying test(after the first week of protocol)
- Gainotti's drawing copying test(After the third week of protocol)
- The Map of France test(Immediately following first session of occupational therapy.)
- The Map of France test(After the first experimental session)
- The Map of France test(After the first week of protocol)
- The Map of France test(After the third week of protocol)
- The Subjective Straight-Ahead test(At the end of the first week of inclusion)
- The Subjective Straight-Ahead test(Immediately following first session of occupational therapy.)
- The Subjective Straight-Ahead test(After the first week of protocol)
- The Subjective Straight-Ahead test(After the third week of protocol)
- The Wheelchair navigation test(At the end of the first week of inclusion)
- The Wheelchair navigation test(Immediately following first session of occupational therapy.)
- The Wheelchair navigation test(After the first week of protocol)
- The Wheelchair navigation test(After the third week of protocol)