Please select the eligibility criteria that correspond to the clinical trial below.
Title: Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation - a Feasibility Study
Brief Summary: Stroke is the most common cause of adult disability. Current treatments for functional loss of the upper extremity post-stroke remain limited in efficacy, particularly for those with moderate to severe impairment.

Previous studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is effective to enhance motor recovery, with activation of neural pathways similar to that of motor execution. This treatment is accessible to more severely impaired stroke survivors. Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is detected by surface EEG and translated to execution of the target movement with the aid of an arm robot (MIT-Manus).

In this study, we investigate the feasibility of combining robot-assisted MI-BCI training, with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI. Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic stimulation (TMS).

We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI) vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each session. Primary outcome will be functional ability measured by upper extremity component of the Fugl-Meyer Assessment. Secondary outcome measures will be the Box \& Block Test, Modified Ashworth Score (measuring spasticity), grip strength and measures of brain activity including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures including functional MRI and diffusion tensor imaging (DTI).

This study will be important to develop a new and effective treatment (tDCS-BCI) for post-stroke motor impairment.


Options:
A: Inclusion Criteria:

* Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment.
* Unilateral paresis of upper limb
* National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b .
* Ability to provide written informed consent (patient ou legal representative).

Exclusion Criteria:

* Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke.
* Neurologic diseases except migraine.
* Modified Rankin Scale \> 2 prior to stroke.
* Advanced systemic disease such as cancer or advanced chronic renal disease.
* Clinical instability such as uncontrolled cardiac arrhythmia or heart failure.
* Contraindication for physical therapy.
* Pregnancy.
* Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker.
* Comprehension aphasia
* Dementia
* Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem
B: Inclusion Criteria:

* stroke onset \>3 months prior to study enrollment
* subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side
* subject can move, stand up and stand firmly with constrained healthy hand
* subject can perform training 6 hours daily in 2 weeks
* subject is able to understand instructions and be able to cooperate

Exclusion Criteria:

* pregnancy
* contraindications to MRI of brain
* epilepsy, major psychiatric disease
* excessive pain that prevents training
* history of other diseases resulting decreased mobility of affected upper limb
C: Inclusion Criteria:

* first ever haemorrhagic or ischaemic subcortical stroke more than 9 months prior to study enrollment
* upper extremity impairment of 11-45 on the Fugl-Meyer assessment scale

Exclusion Criteria:

* epilepsy
* neglect
* cognitive impairment
* other neurological or psychiatric diseases
* severe arm pain
* spasticity score \>2 on the Modified Ashworth Scale in the shoulder or elbow
* contraindications to TMS or tDCS (cranial implants, ventricular shunts, pacemakers, intrathecal pumps)
* grip strength \<10kg as measured by a dynamometer
* participation in other interventions or trials targeting stroke motor recovery.
D: Inclusion Criteria:

1. Age over 21 years
2. Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
3. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
4. Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
5. Ability to give informed consent and understand the tasks involved.

Exclusion Criteria:

1. Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
2. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
3. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
4. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
5. History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
6. Inability to sit in a chair and perform upper limb exercises for one hour at a time.
7. Participation in another upper extremity rehabilitative therapy study during the study period.
8. Terminal illness
9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.

Answer: C