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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: cTBS; Device: cathodal tDCS; Device: sham stimulation

• Registration Number: NCT02031107
• Lead Sponsor: Adrian Guggisberg

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cTBS	cTBS	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.
cathodal tDCS	cathodal tDCS	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	sham stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change in alpha-band coherence between the affected motor cortex and the rest of the brain	Week 4	Calculated from electroencephalography recordings
Change in compound motor score slope at week 4	week 4 after treatment start	The Fugl Meyer motor assessment (FMA), the Nine Hole Peg test (expressed as pegs per minute), and the Jamar dynamometer strength of the affected arm are normalized to the healthy arm and averaged to a compound motor score. This score is obtained twice before treatment (at weeks -1 and 0 relative to treatment start), and twice after treatment (at weeks 4 and 8). Primary outcome measure is the change in slope from week 0 to 4 as compared to the slope between week -1 and 0.

Secondary Outcome Measures

Name	Time	Method
Change in Fugl Meyer Upper Extremity Motor Score at week 8	Week 8
Change in activity of daily life scale (motor activity log, MAL)	Week 8
Change in Fugl Meyer Upper Extremity Motor Score at week 4	Week 4
Number of adverse events	Week 8
Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain	Week 4

Trial Locations

Locations (1)

Service de Neurorééducation, Unversity Hospital; 🇨🇭 Geneva, Switzerland