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

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ClinicalTrials.gov Identifier: NCT02031107
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Stroke Device: cTBS Device: cathodal tDCS Device: sham stimulation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation in Subacute Stroke
Study Start Date : September 2013
Primary Completion Date : March 2016
Study Completion Date : March 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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.
Device: cTBS
Other Name: MagPro X100
Active Comparator: 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.
Device: cathodal tDCS
Other Name: NeuroConn
Sham Comparator: 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.
Device: sham stimulation


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031107


Locations
Switzerland
Service de Neurorééducation, Unversity Hospital
Geneva, Switzerland, 1211
Sponsors and Collaborators
Adrian Guggisberg
Swiss National Science Foundation
Investigators
Principal Investigator: Adrian G Guggisberg, MD University Hospital, Geneva
More Information

Publications:
Responsible Party: Adrian Guggisberg, Médecin adjoint agrégé, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02031107     History of Changes
Other Study ID Numbers: SNF-146639-1
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Adrian Guggisberg, University Hospital, Geneva:
stroke
brain stimulation
electroencephalography
functional magnetic resonance imaging
functional connectivity

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases