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:

* 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.
B: Inclusion Criteria:

1. Ischemic stroke affecting the right hemisphere, confirmed by CT or MRI.
2. Persistent neglect for one month after ictus (confirmed by BIT).
3. Prestroke functional independence (modified Rankin Scale score 0-2).
4. Between 18-90 years of age

Exclusion Criteria:

1. Patients younger than 18.
2. Patients who do not understand verbal or written English (ie.need of translaters)
3. bilateral infarcts (Confirmed by CT, MRI)
4. Dementia (MOCA, Score \<26).
5. Neurological Disease (eg. Parkinson's Disease, epilepsy, MS)
6. Significant morbidity (eg cancer, severe cardiac failure) likely to affect participation.
7. Alcohol excess (more than 50/40 units a week for men/women respectively).
8. Patients who fall under the exclusion criteria for TDCS which includes patients suffering from a stroke related seizure :

History of epilepsy, medications or psychoactive drugs that can lower seizure threshold \[imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel dust), ketamine, gammahydroxybutyrate (GHB), alcohol, theophylline\]. Withdrawal from alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate. Patients who are pregnant or have suffered from a stroke-related seizure.
C: Inclusion Criteria:

* Age \> 18 years
* National health insurance cover
* 1st minor ischaemic stroke (initial NIH score ≤ 4)
* Satisfactory neurological recovery at discharge from hospital (modified Rankin score ≤2)
* Patient living close to the participating centre (\<50 km)
* With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))

Exclusion Criteria:

* haemorrhagic stroke
* History of ischaemic or haemorrhagic stroke with clinical manifestations
* History of TIA
* MMS ≤ 24
* Pre-existing dementia (defined according to DSM IV criteria)
* Neurosensory or orthopaedic disorders requiring permanent technical support before the stroke and making reconditioning impossible
* Aggravation of the neurological status after the initial hospitalisation (NIH score ≥ 6)
* Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event between the screening and definitive inclusion
* Pre-stroke Rankin score ≥ 3
* Pregnant patient
* Patient under guardianship
D: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18-85
* At least one month post ischaemic or haemorrhagic stroke or brain damage to the right hemisphere
* Diagnosis of neglect confirmed by evidence of neglect on at least one of the tests in the battery of neglect tests administered during the Recruitment Interview

Absolute contraindications to participation in any part of the study:

* Anyone who does not have adequate understanding of English, sufficient to give informed consent
* Limited verbal communication in the form of dysphasia
* Any person who has a history of drug abuse as the data collected may be influenced by their condition
* Any person who has a history of dementia or any other psychiatric illness as the data collected may be influenced by their condition

Absolute contraindications to participation in the tDCS part of the study:

* Anyone who has a previous personal history of epilepsy, seizures, febrile convulsions as a child or recurrent fainting fits will be excluded from the tDCS part of the study
* Any metallic implant in the neck, head, or eye that is situated within the path of the tDCS current, and anyone with any implanted electrical devices, would be excluded as there is a risk of heating with tDCS
* Pregnant women are excluded as a precaution as there are no data on the effect on maternal tDCS or MRI on the foetus

Absolute contraindications to participation in the MRI part of the study:

* People who suffer from claustrophobia will be excluded from the MRI part of the study if they state they are unable to tolerate the scanner environment
* Anyone with a metal implant or implantable device that is found to be unsafe or unknown for MRI following investigations by named researchers and staff radiographers would be excluded.
* Pregnant women are excluded as a precaution as there are no data on the effect on maternal tDCS or MRI on the foetus

Potential contraindications to participation in the tDCS part of the study:

* Participants on some prescription medications such as anti-depressants or pain medication may be excluded as they may be at an increased risk of seizure
* Individuals who have a family history of epilepsy or seizure may be excluded as this may increase the individual's personal risk of susceptibility to seizures

Potential contraindications to participation in the MRI part of the study:

• An individual with a previous history of a surgical procedure may be excluded, depending on whether a metallic implant was used in their operation and whether the MRI-safety status of the implanted materials can be adequately assessed after requesting the medical/surgical notes (with patient consent) and/or post-surgical imaging and consulting with the staff radiographers who are legally responsible for determining participant safety in advance of any scanning.

Answer: A