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:

* Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
* Ability to reach 60 degrees in the shoulder flexion
* Minimal cognitive ability to understand commands
* No current use of antiepileptic drugs for seizures

Exclusion Criteria:

* Painful shoulder, adhesive capsulitis or glenohumeral subluxation
* Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire
B: Inclusion Criteria:

* Diagnosed with stroke that occurred at least 6 months ago

Exclusion Criteria:

* Pregnant
* Ongoing use of Central Nervous System activating medications
* Presence of an electrically, magnetically or mechanically activated implant, including cardiac pacemaker, cochlear implant
* Metal in the head
* A history of medication-resistant epilepsy in the family
* Past history of seizures or unexplained spells of loss of consciousness
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. persons affected by first supratentorial stroke, whose onset time is 25±7 days;
2. upper limb hemiparesis;
3. cognitive and speech abilities sufficient to understand instructions and to provide informed consent;
4. absence of intense pain due to passive wrist mobilization assessed by VAS \< 3 (range 0-10);
5. ability to provide written informed consent.

Exclusion Criteria:

1. previous epilepsy seizures;
2. severe electroencephalographic anomalies;
3. previous neurosurgery interventions involving metallic elements placement;
4. ongoing anticonvulsant drugs treatment
5. inability to keep sitting posture;
6. severe sensory deficits;
7. general clinical complication preventing delivery of rehabilitation treatment.

Answer: C