TDCS Enhanced Stroke Recovery and Cortical Reorganization

Study ID
STU 082010-108

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Shanteria Cobb
(214) 648-0315
shanteria.cobb@utsouthwestern.edu

Principal Investigator
Patricia Smith

Summary

This study will be performed at uT Southwestern Medical Center (uTSW) and Parkland Health and Hospital system (PHHS). The follow-up testing with TMS will be performed either at uTSW or at university of Texas at Dallas. The total expected recruitment will be 160.
Patients will be included in the protocol as soon as they are admitted to uTSW/PHHS for rehabilitative training (RT) (usually 3-10 days after the actual event). eligible Patients, on the basis of inclusion and exclusion criteria, will be randomized either in rehabilitative training (RT) + transcranial Direct Current Stimulation (tDCS) or in RT + placebo stimulation. TDCS will be applied simultaneously with rehabilitative therapy. in both study arms, patients will take part in daily customary rehabilitation procedures.

TDCS is a noninvasive form of cortical stimulation that uses a battery-powered device. Weak current (1 ma) will be delivered for 20 minutes through surface electrodes which will be positioned above the motor cortical representational field of the affected hand and over the contralesional forehead. anodal stimulation increases corticomotor excitability, whereas cathodal stimulation decreases it. The main clinical outcome measures will be the upper extremity componenet of the Fugl-Meyer scale at 3 months. We will also measure the Jebsen-Taylor test, Wolf motor function test, Modified Medical Research Council Scale, niH stroke scale, abilhand questionnaire, Barthel index, Modified rankin scale, ashworth spasticity scale, Mini mental status examination and Beck's depression inventory. The neuroimaging component of the trial will provide preliminary data for future studies on cortical plasticity as measured by voxel count and intensity in the affected primary motor cortex and dorsal premotor cortex.

TDCS is an investigational device that is painless, easy to apply, and without reported side effects. For these reasons, FDa regulation in the form of investigational device exemption (iDe) is not required. This technique has been applied in thousands of subjects worldwide and many healthy volunteers and chronic stroke patients in Dr. Cohen's laboratory in the absence of undesirable side effects. Since tDCS elicits virtually no sensations, it is relatively easier to design sham interventions than when using for example TMS.

We will consent 100 stroke patients and up to 30 healthy volunteers and 30 chronic stroke volunteers. Healthy volunteers and chronic stroke patients will not participate in the interventional component of the study. They will only participate in testing the experimental paradigm for TMS and fMRi. up to 5 completed sessions of fMRi and TMS will be done over 1-3 days to avoid fatigue. The study will last for 4 years but the individual participant will be involved for only one year.

Participant Eligibility

1.We will include English/non-English speaking patients of all races/ethnicity, with moderate to severe hand weakness (upper extremity component of the fugl-meyer (uFM) less than 60) who have at least 30 degrees of flexion and 15 degrees of extension passive range of motion at wrist, aged 18 to 85 years old who experienced thromboembolic nonhemorrhagic subcortical or cortical symptomatic strokes within 5-15 days before enrollment into this study and classify them according to the degree of impairment into mildly impaired ( modified medical research council scal (MRC) > 1) and severely impaired (MRC equal or < 1). Assessment of the initial functional state will be taken at the admission at UTSW.
2.Chronic stroke patients will have the same inclusion criteria as acute stroke patients, except for their stroke will have happened more then 3 months prior to the enrollment.
3.For healthy volunteers, we will include the subjects with a normal physical and neurological examination.