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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Cathodal tDCS Device
    ARM 1: Kind: Experimental
    Label: cathodal tDCS
    Description: A stimulator (NeuroConn GmbH, Illmenau, Germany) will deliver cathodal transcranial direct current stimulation (tDCS) of the unaffected motor cortex. The anode will be placed over the contralateral supraorbital region. Stimulation will be performed for 25 min, 3 times per week for 3 weeks during upper extremity treatment sessions.
  • Sham stimulation Device
    ARM 1: Kind: Experimental
    Label: sham stimulation
    Description: This group will receive the same stimulation protocol as used for the active groups except that sham stimuli will be applied. Half of the patients receive sham cTBS, the other half sham tDCS.
  • CTBS Device
    Other Names: MagPro X100
    ARM 1: Kind: Experimental
    Label: cTBS
    Description: A transcranial magnetic stimulator (MagPro X100, Medtronic Functional Diagnostics, Skovlunde, Denmark) will deliver continuous bursts of bipolar magnetic pulses exerting an inhibition on the underlying brain tissue (cTBS). The stimulation coil will be placed over the unaffected primary motor cortex. The stimulation protocol implies 200 bursts, each consisting of three pulses applied at 30 Hz, repeated at inter-burst intervals of 167 ms. Two stimulation trains of 30 s, separated by 15 min, will be applied 3 times per week for 3 weeks and will be immediately followed by physical therapy.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in compound motor score slope at week 4 week 4 after treatment start No
Primary Change in alpha-band coherence between the affected motor cortex and the rest of the brain Week 4 No
Secondary Compound motor score at week 8 Week 8 No
Secondary change in correlations of spontaneous fMRI fluctuations within the motor network Week 4 No
Secondary change in alpha-band coherence between the unaffected motor cortex and the rest of the brain Week 4 No
Secondary Change in fractional anisotropy of the affected cortico-spinal tract Week 4 No
Secondary Change in activity of daily life scale (motor activity log, MAL) Week 4 No
Secondary Number of adverse events Week 4 Yes
Secondary Change in Fugl Meyer Upper Extremity Motor Score at week 4 Week 4 No
Secondary Change in Fugl Meyer Upper Extremity Motor Score at week 8 Week 8 No

Sponsors