Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Immediate Effect of Electrical Stimulation Transcranial Direct Current (tDCS) Associated With the Use of FES, in Muscle Activity of the Tibialis Anterior Muscle, Balance and Plantar Pressure Distribution of Individuals With Hemiparesis Due to Stroke - Randomized, Double Blind
Brief Summary: Background: Transcranial direct current stimulation (tDCS) is currently considered a beneficial method for patients with neurological problems due to the modulation of cortex activity as well as the enhancement and prolongation of functional gains achieved during physical therapy. Purpose: The aim of the proposed study is to evaluate the immediate effects of a session of tDCS over the primary motor cortex combined with functional electrical simulation (FES) on electrical activity of the tibialis anterior muscle, balance and distribution of plantar pressure in individuals with hemiparesis stemming from a stroke. A further aim is to determine whether the effects of the combination of both stimulation methods are better than those achieved when each method is employed alone. Methods/design: A randomized, double-blind, crossover, cross-sectional study will be conducted involving 30 stroke survivors with hemiparesis who meet the eligibility criteria. Evaluations will involve an identification and screening chart, the classification of motor impairment using the Fugl-Meyer Scale, the determination of spasticity of the triceps surae muscle (modified Ashworth scale), electromyography of the tibialis anterior muscle, static balance and cognitive dual-task balance (stabilometry) and plantar pressure. After the initial evaluations, the participants will undergo four interventions: 1) anodal tDCS + placebo FES + active tibialis anterior contraction; 2) placebo tDCS + active FES + active tibialis anterior contraction; 3) anodal tDCS + active FES + active tibialis anterior contraction; and 4) placebo tDCS + placebo FES placebo + active tibialis anterior contraction. tDCS will be administered over the primary motor cortex and FES will be administered over the tibialis anterior muscle. The order of the different protocols will be randomized and both the evaluator and patients will be blinded to which protocol is being administered.


Options:
A: Inclusion Criteria:

- first -ever ischemic stroke within 5-30 days a paresis of the arm/hand with NIHSS \<15 age 35-85 years

Exclusion Criteria:

Pregnancy psychiatric disease patients with history of alcohol or drug abuse or severe depression patients with a severe language disturbances, particularly of receptive nature patients with increased intracranial pressure or serious cardiac disease patients with contraindication to TMS
B: Inclusion Criteria:

* age between 18 and 86
* patient is contractually capable
* first-ever, ischemic stroke
* minimum time since stroke 9 months
* a paresis of the arm/hand muscles above 3 on the MRC scale

Exclusion Criteria:

* multiple cerebral lesions and associated residual deficits
* severe head trauma in the past
* seizures
* ferromagnetic implants in the head/neck region
* pacemaker
* a psychiatric disorder or neurological disease besides stroke
* intake of illegal drugs
* severe aphasia or cognitive deficits that impede contractual capability
* contraindications for reboxetine (seizures, glaucoma, prostate hyperplasia with urinary retention, cardiac arrhythmias, potential interactions with co-medication)
* pregnancy
* breast-feeding patients
C: 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.
D: Inclusion criteria:

* 30 individuals with hemiparesis stemming from a stroke;
* Either gender;
* Able to maintain a standing position without an assistance device for at least 60 seconds;
* Signed statement of written consent.

Exclusion criteria:

* Adverse health condition (beyond hemiparesis) that affects balance;
* Use of medication that can affect balance;
* Positive cutoff point for cognitive deficit (Mini Mental State Examination);
* Illiteracy;
* Wernicke's aphasia;
* Reduced ankle mobility due to history of ankle fracture and use of pins in ankle;
* TA muscle strength less than grade 1;
* Contraindication for tDCS (history of recurrent seizures, recurrent epilepsy and brain tumor in stimulation site);
* Skin infection at tDCS and/or FES site;
* Anesthesia or hyperesthesia at FES site.

Answer: D