Timing Matters: Comparing Pre , Peri , and Post Rehabilitation tDCS in Acute Stroke Recovery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in upper limb motor function (Wolf Motor Function Test, WMFT)
研究概览
简要总结
This randomized, double-blind, sham-controlled clinical trial investigates how the timing of transcranial direct current stimulation (tDCS) influences functional recovery during acute stroke rehabilitation. 198 hospitalized patients with confirmed acute stroke will be randomly assigned to one of three groups. Each day, all participants will receive three tDCS sessions: one before, one during, and one after their rehabilitation session. In each group, only one of these three daily stimulations is active, while the other two are sham, allowing a direct comparison of timing effects while maintaining blinding. All participants will complete 2 sets of five consecutive days of conventional rehabilitation combined with the tDCS protocol (2 weeks). Functional, sensory, psychological, and motor outcomes will be assessed at baseline and at the end of the intervention week. The study aims to determine whether the timing of tDCS application influences early post-stroke recovery and to inform the design of future confirmatory trials.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization for stroke rehabilitation Hospitalized in a stroke rehabilitation unit at CHU de Liège.
- •Confirmed acute stroke Diagnosis of acute stroke (ischemic or hemorrhagic) confirmed by neuroimaging, according to local clinical practice.
- •Time since stroke In the acute/subacute phase, as defined in the protocol (e.g., within X days/weeks after stroke onset) - to be specified exactly as in your protocol.
- •Age Age ≥ 18 years.
- •Capacity to consent Able to understand the study information and provide written informed consent.
- •Motor impairment of the upper limb Presence of motor deficit of the upper limb on the affected side, sufficient to perform the WMFT tasks (according to protocol thresholds, if specified).
- •Medically stable Clinically stable and judged by the treating physician as able to participate in daily rehabilitation and tDCS sessions.
排除标准
- •Contraindications to tDCS or cranial stimulation
- •Implanted electronic devices in the head or neck (e.g., deep brain stimulator, cochlear implant, implanted neurostimulator, pacemaker with leads near the head).
- •Metal implants in the skull (excluding dental fillings) in the area of stimulation.
- •Large skull defect or craniectomy over the stimulation site.
- •History of seizures History of epilepsy or unprovoked seizures not adequately controlled, if considered a contraindication to tDCS by the investigator.
- •Severe cognitive or communication impairment Severe cognitive impairment, aphasia, or comprehension difficulties preventing understanding of the study or execution of the tasks, as judged by the investigator.
- •Severe comorbidities Unstable medical conditions (e.g., uncontrolled cardiac, respiratory, metabolic, or systemic disease) that could interfere with participation or increase risk.
- •Severe psychiatric disorder Current severe psychiatric illness (e.g., psychosis, severe untreated major depression) that may affect cooperation or safety, as judged by the investigator.
- •Skin conditions at electrode sites Skin lesions, infections, severe dermatitis, or wounds at or near the planned electrode placement sites.
- •Concurrent participation in another interventional trial Participation in another interventional clinical trial that could interfere with the outcomes or safety of this study.
- •Pregnancy Pregnancy or breastfeeding, if considered a contraindication according to local tDCS safety policy (optional, depending on your protocol stance).
- •Any other reason Any condition or circumstance that, in the opinion of the investigator, makes the patient unsuitable for the study or unable to comply with the protocol.
研究组 & 干预措施
Arm 3 - Active tDCS After Rehabilitation
Active tDCS After Rehabilitation
干预措施: Sham Transcranial Direct Current Stimulation (Sham tDCS) (Device)
Arm 1 - Active tDCS Before Rehabilitation
Active tDCS Before Rehabilitation
干预措施: tDCS (Device)
Arm 1 - Active tDCS Before Rehabilitation
Active tDCS Before Rehabilitation
干预措施: Sham Transcranial Direct Current Stimulation (Sham tDCS) (Device)
Arm 2 - Active tDCS During Rehabilitation
Active tDCS During Rehabilitation
干预措施: tDCS (Device)
Arm 2 - Active tDCS During Rehabilitation
Active tDCS During Rehabilitation
干预措施: Sham Transcranial Direct Current Stimulation (Sham tDCS) (Device)
Arm 3 - Active tDCS After Rehabilitation
Active tDCS After Rehabilitation
干预措施: tDCS (Device)
结局指标
主要结局
Change in upper limb motor function (Wolf Motor Function Test, WMFT)
时间窗: Baseline (Day 1, pre-intervention) to end of intervention (Day 5, post-intervention).
The WMFT assesses upper limb motor function using timed and functional tasks. The primary outcome is the change in WMFT performance (time and/or functional score) between baseline and Day 5, comparing the three timing conditions of active tDCS (before, during, after rehabilitation). The Wolf Motor Function Test (WMFT) will be used to assess upper-limb motor performance. The Functional Ability Scale ranges from 0 to 5, with higher scores indicating better functional movement quality. Performance Time is measured from 0 to 120 seconds, with lower times indicating better performance.
Change in upper limb motor function (Wolf Motor Function Test, WMFT)
时间窗: Baseline (Day 1, pre-intervention) to end of intervention (Day 5, post-intervention).
The WMFT assesses upper limb motor function using timed and functional tasks. The primary outcome is the change in WMFT performance (time and/or functional score) between baseline and Day 5, comparing the three timing conditions of active tDCS (before, during, after rehabilitation). The Wolf Motor Function Test (WMFT) will be used to assess upper-limb motor performance. The Functional Ability Scale ranges from 0 to 5, with higher scores indicating better functional movement quality. Performance Time is measured from 0 to 120 seconds, with lower times indicating better performance.
次要结局
- Change in spasticity (Tardieu Scale)(Baseline (Day 1) to Day 5.)
- Change in functional independence (Barthel Index)(Baseline (Day 1) to Day 5.)
- Change in balance and gait (Tinetti Performance-Oriented Mobility Assessment)(Baseline (Day 1) to Day 5.)
- Change in health-related quality of life after stroke (Stroke Impact Scale, SIS)(Baseline (Day 1) to Day 5.)
- Change in anxiety and depression (Hospital Anxiety and Depression Scale, HADS)(Baseline (Day 1) to Day 5.)
- Incidence of adverse events and tolerability of tDCS(Throughout the 5 days of intervention.)
- Change in sensory function (Semmes-Weinstein Monofilament Test, SWMT)(Baseline (Day 1) to Day 5.)
- Change in spasticity (Tardieu Scale)(Baseline (Day 1) to Day 5.)
- Change in health-related quality of life after stroke (Stroke Impact Scale, SIS)(Baseline (Day 1) to Day 5.)
- Change in sensory function (Semmes-Weinstein Monofilament Test, SWMT)(Baseline (Day 1) to Day 5.)
- Change in functional independence (Barthel Index)(Baseline (Day 1) to Day 5.)
- Change in balance and gait (Tinetti Performance-Oriented Mobility Assessment)(Baseline (Day 1) to Day 5.)
- Change in anxiety and depression (Hospital Anxiety and Depression Scale, HADS)(Baseline (Day 1) to Day 5.)
- Incidence of adverse events and tolerability of tDCS(Throughout the 5 days of intervention.)
研究者
Bornheim Stephen
Prof.
University of Liege