Using Transcranial Direct Current Stimulation (tDCS) to Enhance the Benefit of Movement Training in Stoke Patients

Individuals who have suffered a stroke may benefit from the development of new rehabilitative interventions that can improve motor recovery after a stroke.

Objective:

The objective of this protocol is to test the hypothesis that active training on a complex upper extremity visuomotor task combined with anodal transcranial direct current stimulation (tDCS) used to activate the affected hemisphere improves functionality during reaching of the affected upper-extremity in comparison to training combined with sham tDCS in stroke patients.

The Study population:

The study population will include chronic (more than 3 months) stroke patients.

Design:

The study will follow a factorial design in which all subjects will undergo several sessions of complex visuomotor task training of the upper extremity. One half of the patients will undergo anodal transcranial direct current stimulation during the first 20 minutes of each training session, while the control subjects will have sham stimulation applied.

Outcome Measures:

The primary outcome measure for the study is accuracy during completion of a reaching task. The primary endpoint for the study will be the end of 3 weeks of training (15 days). Secondary endpoint measures include timing of reach, kinematic, and functional measures. These measures will be taken at the end of training and at a 3 month follow-up.

• INCLUSION CRITERIA:
• Age between 18 and 85 years.
• Ability to sit and be active for an hour on a chair (or wheelchair) without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
• Willingness to commit to participate in the long-term follow-up study (up to 3 months)
• Willingness to give written informed consent.
• Diagnosis of a first clinically apparent unilateral cortical or subcortical stroke at least 3 months prior to study entry

Exclusion criteria

• History of severe neurological illness (e.g. brain tumor, epilepsy or acute seizures, polyneuropathy etc.) or severe cognitive impairment (MMSE less than 23)
• MRI contraindications. (Cardiac pacemakers; Intracardiac lines; Implanted medication pumps; Neural stimulators; blood vessel, cochlear, or eye implants; Metal in the cranium except in the mouth; Dental braces; Metal fragments from occupational exposure; Surgical clips in or near the brain).
• History of alcohol or drug abuse
• Active depression of any severity with psychoactive medication changes in the last 2 months, active psychosis, disruptive or violent behavior, poor motivational capacity as assessed by the study physician by patient questioning
• Aphasia or language disturbances that would interfere with performing the study tasks
• Uncontrolled medical problems (e.g., active cancer or renal disease, any type of end-stage pulmonary or cardiovascular disease, diabetes, or other medical conditions, as determined by the study physician, that would interfere with participation in this study).
• Increased intracranial pressure as evaluated by clinical means (fundoscopic exam).
• Severe neglect or ataxia that would interfere in the completion of the study tasks.
• History of more than one stroke or a stroke that affects both sides of the brain, the brainstem, or the cerebellum.
• Inflammation of the tissue, severe rheumatoid arthritis, or abnormal function of the joints due to arthritis in the affected arm used most often.
• Pregnancy