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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031107
• Other study ID #: SNF-146639-1
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: May 11, 2016
• Start date: September 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Laws and standards
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• cTBS

• cathodal tDCS

• sham stimulation

Locations

Country	Name	City	State
Switzerland	Service de Neurorééducation, Unversity Hospital	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Adrian Guggisberg	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Fugl Meyer motor assessment score at week 4		Week 4	No
Other	Total Fugl Meyer motor assessment score at week 8		Week 8	No
Other	Change in average velocity in the Nine Hole Peg test at week 4	expressed in pegs/sec	Week 4	No
Other	Change in average velocity in the Nine Hole Peg test at week 8	expressed in pegs/sec	Week 8	No
Other	Change in Jamar Dynamometer strength at week 4		Week 4	No
Other	Change in Jamar Dynamometer strength at week 8		Week 8	No
Other	Change in Score of the Box and Block test, week 4		Week 4	No
Other	Change in Score of the Box and Block test, week 8		week 8	No
Other	Correlation between change in alpha band coherence and clinical improvements	Alpha band coherence is calculated from electroencephalography (EEG) recordings	Week 4	No
Other	Change in fractional anisotropy of the affected cortico-spinal tract	Calculated from diffusion tensor imaging (DTI) sequences of magnetic	Week 4	No
Other	Change in correlations of spontaneous fMRI fluctuations within the motor network	Calculated from functional magnetic resonance (fMRI) recordings	Week 4	No
Primary	Change in compound motor score slope at week 4	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.	week 4 after treatment start	No
Primary	Change in alpha-band coherence between the affected motor cortex and the rest of the brain	Calculated from electroencephalography recordings	Week 4	No
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
Secondary	Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain		Week 4	No
Secondary	Change in activity of daily life scale (motor activity log, MAL)		Week 4	No
Secondary	Change in activity of daily life scale (motor activity log, MAL)		Week 8	No
Secondary	Number of adverse events		Week 4	Yes
Secondary	Number of adverse events		Week 8	Yes