Patient-tailored Transcranial Direct Current Stimulation to Improve Stroke Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Pilot outcome
研究概览
简要总结
In a double-blinded sham-controlled study the effect of patient-tailored transcranial direct current stimulation during rehabilitation training will be examined.
详细描述
Approximately two thirds of stroke patients have reduced motor function which have a large impact on both activities of daily living and quality of life. Only 12-34% achieve full motor recovery.
There is a growing interest in using non-invasive brain stimulation (NIBS) techniques to supplement neurorehabilitation. NIBS can modulate cortical excitability and is a powerful tool for motor rehabilitation post-stroke. Application Transcranial Direct Current Stimulation (TDCS) is currently emerging as a tool used in neurorehabilitaiton. Prior studies have shown that TDCS-stimulation prior to physical training may significantly improve of motor function post-stroke. However, up to 50% of the participants recieving active TDCS show no response to stimulation.
A one-size-fits-all approach to TDCS in stroke rehabilitation may not be optimal and a more precise and individualized targeting is warranted to stimulate functionally relevant areas.
In this study TDCS will be personalized for stroke patients with upper-extremity paresis using individual functional and structural Magnetic Resonance Imaging (MRI) and an electric field modelling pipeline developed at Danish Research Centre for Magnetic Resonance (DRMCR). Based on these measures the electric current induced by TDCS will individually target the area with residual neural activity during movement. The effect of personalized TDCS will be assessed by clinical measures of motor improvement. Sub-studies furthermore assess if the functional reorganization of motor networks is affected by personalized TDCS by application of functional magnetic resonance (fMRI) and.
The study will have 3 phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Age >18 years
- •Ischemic stroke confirmed by clinical and imaging criteria
- •Hemiparesis including reduced upper-extremity function
- •Location of stroke either cortically involving middle cerebral artery or the anterior cerebral artery circulation or subcortical (involving thalamus, basal ganglia).
- •NIHSS score >2 and <8
- •Modified Rankin Scale (mRS) ≤ 3
- •Index of stroke within 4 weeks of inclusion
- •Signed informed consent
排除标准
- •>50% stenosis of extra- or intracranial artery as well as vascular malformations or aneurisms detected by brain CT-angiography.
- •Exclusively ischemic stroke in spine, pons, brainstem, medulla or cerebellum.
- •History of seizures, epilepsy, anxiety, dementia alcohol- or drug abuse.
- •Prior serious head injury or neurosurgery
- •Frequent severe headaches or migraine.
- •Pregnancy or breastfeeding
- •Current use of neuro-receptor/transmitter modulating medication, or medication interfering with seizure threshold (such as antiepileptic medication, some antidepressants, anxiety medication, antihistamines, stimulant drugs for attention deficit hyperactivity disorder).
- •Pacemaker, implantable cardiac device unit (ICD-unit), metal fragments or other materials implanted not compatible with MRI (see appendix B).
- •Claustrophobia
- •Prior adverse effect to TDCS or Transcranial Magnetic Stimulation.
- •Not able to provide informed consent.
- •Terminally ill or short life expectancy.
- •Healthy controls - Inclusion criteria:
- •Age between >18 years (matched to patients)
- •Sex and age matched to patients
- •Able bodied
- •Have the ability to comply with all requirements of the study protocol, as determined by the investigator
- •No history of stroke or dementia
- •Eligible for MRI and TMS
- •Healthy controls - Exclusion Criteria:
- •History of neurologic disease
- •History of cerebral haemorrhage or brain damage
- •Pacemaker or other implanted electronic devices
- •Claustrophobia
- •Psychiatric disorder
- •Epilepsy or close relatives suffering from epilepsy
- •Any contraindication to MRI or TMS
结局指标
主要结局
Pilot outcome
时间窗: From baseline to four months
Difference in Upper-extremity Fugl-Meyer Assessment (UE-FMA) score at end of treatment. Range 0-66.
次要结局
- Change in upper-extremity function(From baseline to four months)
- Feasibility: Patient feed-back(Follow-up1)
- Stroke severity(From baseline to four months)
- Gait speed(From baseline to four months)
- WHO-5 Well-Beeing Index(From baseline to four months)
- fMRI - Interhemispheric inhibition(From baseline to four months)
- fMRI - Laterality Index(From baseline to four months)
- MRI - Infarct lesion load(From baseline to four months)
- MRI - Cerebral bloodflow(From baseline to four months)
- Stroke disability(From baseline to four months)
- Physical Activity(From baseline to four months)
- Symbol Digit Modalities Test(From baseline to four months)
- Health-related quality of life(From baseline to four months)
- Upper-extremity motor outcome(From baseline to four months)
- Feasibility: Compliance to interventions(During intervention)
- Feasibilitiy: Compliance to home-exercises(During intervention)
- Biomarker of inflammation and exercise(From baseline to four months)
- fMRI - Effective connectivity(From baseline to four months)
- ADL performance(From baseline to four months)
- Montreal Cognitive Assessment(From baseline to four months)
- Becks Depression Inventory (BDI)(From baseline to four months)
- Fatigue Severity Scale (FSS)(From baseline to four months)
- MRI - Corticospinal integrity(From baseline to four months)
- Feasibility: TDCS sensations(During intervention)
研究者
Christina Kruuse
Study Principal Investigator, Consultant Neurologist, Dept. Neurology, Herlev Hospital
Herlev Hospital