Randomized Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation

Randomized Controlled Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation in Subacute Stroke

Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation can induce significant and sustained improvements in functional outcome. However the effect is inconsistent and difficult to predict, in particular in the subacute phase after stroke. Although several different stimulation techniques are available, it is unknown which is suitable for which patient.

Objectives: This study has three main objectives:

1. To compare the effects of two techniques of non-invasive brain stimulation (cTBC, continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on clinical recovery in patients with subacute stroke.
2. To assess the effect of these brain stimulation techniques on brain organization with non-invasive imaging.
3. To find clinical and neural predictors of responsiveness to brain stimulation therapy.

Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3 groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical therapy. Before and after the treatment period, standardized assessments of sensorimotor function areas are obtained together with electroencephalography and functional magnetic resonance recordings. These recordings will be used to analyze and compare the neural effects of each treatment modality.

Clinical Implication: The results of this study might help optimize and individualize stimulation treatment for patients with subacute stroke. It may hence facilitate the transfer of brain stimulation therapy to routine clinical practice.

Inclusion Criteria:

• ischemic or hemorrhagic stroke leading to unilateral deficits in motor function with significant impact on independence and daily activities at the beginning of rehabilitation
• less than 10 weeks after stroke onset.

Exclusion Criteria:

• epileptic seizures
• metallic objects in the brain
• presence of implants or neural stimulators
• pregnancy
• sleep deprivation
• recent traumatic brain injury
• delirium or disturbed vigilance
• inability to participate in 1h treatment sessions
• severe language comprehension deficits
• skull breach
• new stroke lesions during rehabilitation
• medical complications