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Completed

NCT Number: NCT02031107

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neurorééducation, Unversity Hospital

Geneva, 1211, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cTBS

Device

Other names: MagPro X100

Cathodal tDCS

Device

Other names: NeuroConn

Sham stimulation

Device

Primary outcomes

  1. Change in compound motor score slope at week 4

    Time frame: 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.

  2. Change in alpha-band coherence between the affected motor cortex and the rest of the brain

    Time frame: Week 4

    Calculated from electroencephalography recordings

Secondary outcomes

  1. Change in Fugl Meyer Upper Extremity Motor Score at week 4

    Time frame: Week 4

  2. Change in Fugl Meyer Upper Extremity Motor Score at week 8

    Time frame: Week 8

  3. Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain

    Time frame: Week 4

  4. Change in activity of daily life scale (motor activity log, MAL)

    Time frame: Week 4

  5. Change in activity of daily life scale (motor activity log, MAL)

    Time frame: Week 8

  6. Number of adverse events

    Time frame: Week 4

  7. Number of adverse events

    Time frame: Week 8

Other outcomes

  1. Total Fugl Meyer motor assessment score at week 4

    Time frame: Week 4

  2. Total Fugl Meyer motor assessment score at week 8

    Time frame: Week 8

  3. Change in average velocity in the Nine Hole Peg test at week 4

    Time frame: Week 4

    expressed in pegs/sec

  4. Change in average velocity in the Nine Hole Peg test at week 8

    Time frame: Week 8

    expressed in pegs/sec

  5. Change in Jamar Dynamometer strength at week 4

    Time frame: Week 4

  6. Change in Jamar Dynamometer strength at week 8

    Time frame: Week 8

  7. Change in Score of the Box and Block test, week 4

    Time frame: Week 4

  8. Change in Score of the Box and Block test, week 8

    Time frame: week 8

  9. Correlation between change in alpha band coherence and clinical improvements

    Time frame: Week 4

    Alpha band coherence is calculated from electroencephalography (EEG) recordings

  10. Change in fractional anisotropy of the affected cortico-spinal tract

    Time frame: Week 4

    Calculated from diffusion tensor imaging (DTI) sequences of magnetic

  11. Change in correlations of spontaneous fMRI fluctuations within the motor network

    Time frame: Week 4

    Calculated from functional magnetic resonance (fMRI) recordings

Sponsors and collaborators

Lead sponsor

Adrian Guggisberg

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 9, 2014
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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