Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Brief Summary: The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.

We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.


Options:
A: Inclusion Criteria:

* All subjects must be between the ages of 18-90 and must not be pregnant.
* Patients volunteer to participate in the study, with a written informed consent signed
* Affiliation to a national health insurance program
* First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report
* Contralesional motor deficit
* Lesion sparing primary motor cortex
* Stroke onset \>1 month and \<6 months prior to study enrollment

Exclusion Criteria:

* Coexistent major neurological or psychiatric disease as to decrease number of confounders
* History of epilepsy before stroke (or episodes of seizures within the last six months)
* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
* Subjects with global aphasia and deficits of comprehension
* Excessive pain in any joint of the paretic extremity (VAS\>4)
* Contraindications to Tdcs : metal in the head, implanted brain medical devices
* Coexistent major neurological or psychiatric disease as to decrease number of confounders
* A history of significant alcohol or drug abuse in the prior 6 months
* Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours
* Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke
* Pregnancy
B: Inclusion Criteria:

* First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
* Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
* Ability to stand from a sitting position and ability to stand with or without upper extremity support
* Stroke onset at least 6 months prior to study enrollment

Exclusion Criteria:

* Significant pre-stroke disability
* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
* Excessive pain in any joint of the paretic extremity
* A terminal medical diagnosis consistent with survival of less than 1 year
* Advanced liver, kidney, cardiac, or pulmonary disease
* Coexistent major neurological or psychiatric disease (including epilepsy)
* A history of significant alcohol or drug abuse in the prior 3 years
* Use of neuropsychotropic drugs - such as antidepressants
* Patients may not be actively enrolled in a separate intervention study targeting stroke recovery
* Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke
C: Inclusion Criteria:

* Males and females subjects. Age \> 18 years.
* Diagnosis of first ischemic stroke
* Impairment of the upper limb
* Trunk control defined in the Trunk-Control Test (TCT), with a score \> 50.

Exclusion Criteria:

* anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
* Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
* contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
* Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
* Neurological or psychiatric pathology
* severe cardio-pulmonary, renal, hepatic diseases
* Pregnancy
D: Inclusion Criteria:

* Chronic (\> 6 months) stroke patient
* Aged 18-79 years
* Motor deficit in the upper limb due to the stroke

Exclusion Criteria:

* Absence of recordable MEPs from the ADM after TMS
* Absence of voluntary movement (Fugl-Meyer \< III)
* Head injury or the presence of intracranial metal or intracranial lesions
* History of cranial irradiation
* History of epilepsy
* Presence of a pacemaker
* Taking anticonvulsant or neuroleptic medication
* Substance abuse
* Inability to understand instructions
* History of psychiatric disorders

Answer: B