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

May 11, 2016 updated by: Adrian Guggisberg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Service de Neurorééducation, Unversity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 4 after treatment start
Change in alpha-band coherence between the affected motor cortex and the rest of the brain
Time Frame: Week 4
Calculated from electroencephalography recordings
Week 4

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Fugl Meyer motor assessment score at week 4
Time Frame: Week 4
Week 4
Total Fugl Meyer motor assessment score at week 8
Time Frame: Week 8
Week 8
Change in average velocity in the Nine Hole Peg test at week 4
Time Frame: Week 4
expressed in pegs/sec
Week 4
Change in average velocity in the Nine Hole Peg test at week 8
Time Frame: Week 8
expressed in pegs/sec
Week 8
Change in Jamar Dynamometer strength at week 4
Time Frame: Week 4
Week 4
Change in Jamar Dynamometer strength at week 8
Time Frame: Week 8
Week 8
Change in Score of the Box and Block test, week 4
Time Frame: Week 4
Week 4
Change in Score of the Box and Block test, week 8
Time Frame: week 8
week 8
Correlation between change in alpha band coherence and clinical improvements
Time Frame: Week 4
Alpha band coherence is calculated from electroencephalography (EEG) recordings
Week 4
Change in fractional anisotropy of the affected cortico-spinal tract
Time Frame: Week 4
Calculated from diffusion tensor imaging (DTI) sequences of magnetic
Week 4
Change in correlations of spontaneous fMRI fluctuations within the motor network
Time Frame: Week 4
Calculated from functional magnetic resonance (fMRI) recordings
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adrian Guggisberg

Collaborators

Swiss National Science Foundation

Investigators

  • Principal Investigator: Adrian G Guggisberg, MD, University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 6, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNF-146639-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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