Clinical trial NCT02031107: Randomized Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation
Official title: Randomized Controlled Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation in Subacute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
brain stimulation
electroencephalography
functional magnetic resonance imaging
functional connectivity
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2014-01-09
Enrollment: 41
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in compound motor score slope at week 4
timeFrame: week 4 after treatment start
measure: Change in alpha-band coherence between the affected motor cortex and the rest of the brain
timeFrame: Week 4
Secondary outcomes:
measure: Change in Fugl Meyer Upper Extremity Motor Score at week 4
timeFrame: Week 4
measure: Change in Fugl Meyer Upper Extremity Motor Score at week 8
timeFrame: Week 8
measure: Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain
timeFrame: Week 4
measure: Change in activity of daily life scale (motor activity log, MAL)
timeFrame: Week 4
measure: Change in activity of daily life scale (motor activity log, MAL)
timeFrame: Week 8
measure: Number of adverse events
timeFrame: Week 4
measure: Number of adverse events
timeFrame: Week 8
Other outcomes:
measure: Total Fugl Meyer motor assessment score at week 4
timeFrame: Week 4
measure: Total Fugl Meyer motor assessment score at week 8
timeFrame: Week 8
measure: Change in average velocity in the Nine Hole Peg test at week 4
timeFrame: Week 4
measure: Change in average velocity in the Nine Hole Peg test at week 8
timeFrame: Week 8
measure: Change in Jamar Dynamometer strength at week 4
timeFrame: Week 4
measure: Change in Jamar Dynamometer strength at week 8
timeFrame: Week 8
measure: Change in Score of the Box and Block test, week 4
timeFrame: Week 4
measure: Change in Score of the Box and Block test, week 8
timeFrame: week 8
measure: Correlation between change in alpha band coherence and clinical improvements
timeFrame: Week 4
measure: Change in fractional anisotropy of the affected cortico-spinal tract
timeFrame: Week 4
measure: Change in correlations of spontaneous fMRI fluctuations within the motor network
timeFrame: Week 4
Locations:
city: Geneva
country: Switzerland
facility: Service de Neurorééducation, Unversity Hospital
Study officials:
affiliation: University Hospital, Geneva
name: Adrian G Guggisberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rizk S, Ptak R, Nyffeler T, Schnider A, Guggisberg AG. Network mechanisms of responsiveness to continuous theta-burst stimulation. Eur J Neurosci. 2013 Oct;38(8):3230-8. doi: 10.1111/ejn.12334. Epub 2013 Aug 14.
citation: Nicolo P, Magnin C, Pedrazzini E, Plomp G, Mottaz A, Schnider A, Guggisberg AG. Comparison of Neuroplastic Responses to Cathodal Transcranial Direct Current Stimulation and Continuous Theta Burst Stimulation in Subacute Stroke. Arch Phys Med Rehabil. 2018 May;99(5):862-872.e1. doi: 10.1016/j.apmr.2017.10.026. Epub 2017 Dec 7.