CVA clinical trials

Feasibility of Enhancing Recovery of Sensory Deficits After Stroke With rTMS

Problem: Stroke is a leading cause of disability in the United States . Motor deficits caused by stroke are commonly paired with loss of sensory perception. Sensory deficits significantly impair functional activity and slow down motor recovery during rehabilitation. Several studies demonstrated that for individuals whose sensation was preserved, motor recovery was achieved faster. The main objective of this study is to test the feasibility and preliminary efficacy of novel approach to treat sensory deficits after stroke with combination of repetitive Transcranial Magnetic Stimulation (rTMS) and peripheral arm and hand sensory therapy. Rationale: Sensory deficits can be partially recovered with peripheral manipulation of skin, muscles and joints using sensory re-education-based rehabilitation. Sensory re-education is associated with adaptive functional and structural alterations in the brain, called neuroplasticity. Despite mechanisms of reorganization, sensory recovery is usually slow and incomplete. There is a non-invasive method of brain modulation, called repetitive Transcranial Magnetic Stimulation (rTMS) that can potentially drive the adaptive functional and structural brain changes that lead to functional improvements. Although rTMS of motor control regions has been shown to enhance motor rehabilitation after stroke, evidence in support of enhancement of sensory abilities is only preliminary and rTMS has not been tested to treat sensory deficits. We propose to test the feasibility and preliminary efficacy of rTMS targeting sensory cortical regions to augment effectiveness of sensory rehabilitation. Study Design. We propose to enroll a total of up to 16 individuals with sensory deficits after a first ever stroke (stroke onset > 6 months prior). Subjects will be treated with 5 sensory treatment sessions one week apart that will consist of rTMS with the peripheral sensory re-education rehabilitation therapies (vibration and functional electrical stimulation of the affected arm). rTMS be either facilitatory or inhibitory and will target contralesional primary sensory region. The First Hypothesis is that a combination of rTMS and sensory re-education therapy results in a greater improvement of sensory deficits than sensory therapy alone. We will test this hypothesis by comparing subject's sensory evaluation results between the active and sham rTMS treatment sessions. Sensory evaluation will include a battery of sensory testing measures. The Second Hypothesis is that a combination of facilitatory rTMS and peripheral sensory therapy leads to functional brain changes. We will test this hypothesis by measuring functional brain changes using somatosensory evoked potential (SEP) induced by median nerve stimulation. Overall, the study is designed as a proof of concept to be used for development of a novel approach for sensory rehabilitation after stroke.