StrokeNCT02031107
Randomized Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation
A study testing cTBS and cathodal tDCS in people with Stroke, run by Adrian Guggisberg at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- cTBS and cathodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- epileptic seizures
- metallic objects in the brain
- presence of implants or neural stimulators
- pregnancy
- sleep deprivation
- recent traumatic brain injury
Show all 12Show fewer
- delirium or disturbed vigilance
- inability to participate in 1h treatment sessions
- severe language comprehension deficits
- skull breach
- new stroke lesions during rehabilitation
- medical complications
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service de Neurorééducation, Unversity Hospital
Geneva, 1211
About this study
Official title: 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:
Read more
- 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.
- To assess the effect of these brain stimulation techniques on brain organization with non-invasive imaging.
- 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.
- Conditions
- Stroke
- Being tested
- cTBS, cathodal tDCS, sham stimulation
- Keywords
- stroke, brain stimulation, electroencephalography, functional magnetic resonance imaging, functional connectivity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cTBSDevice
Also called MagPro X100
cathodal tDCSDevice
Also called NeuroConn
sham stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| cTBS | Active comparator | 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. Receives: Device: cTBS |
| cathodal tDCS | Active comparator | 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. Receives: Device: cathodal tDCS |
| sham stimulation | Sham comparator | 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. Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 4 after treatment start
Change in alpha-band coherence between the affected motor cortex and the rest of the brain
Calculated from electroencephalography recordings
Measured: Week 4
Secondary outcomes (7)
Change in Fugl Meyer Upper Extremity Motor Score at week 4
Measured: Week 4
Change in Fugl Meyer Upper Extremity Motor Score at week 8
Measured: Week 8
Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain
Measured: Week 4
Change in activity of daily life scale (motor activity log, MAL)
Measured: Week 4
Change in activity of daily life scale (motor activity log, MAL)
Measured: Week 8
Number of adverse events
Measured: Week 4
Number of adverse events
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrian Guggisberg
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Adrian Guggisberg, University Hospital, Geneva
- Investigators
- Adrian G Guggisberg, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031107
- Sponsor's protocol ID
- SNF-146639-1
- Status last verified
- May 2016
- First submitted
- 6 Jan 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23941616Nicolo 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.
PubMed 29223708
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Transcranial Theta-burst Stimulation and Transcranial Direct Current Stimulation in Subacute Stroke
- ClinicalTrials.gov ID
- NCT02031107
- Acronym / sponsor ID
- SNF-146639-1
- Conditions
- Stroke
- Keywords
- stroke, brain stimulation, electroencephalography, functional magnetic resonance imaging, functional connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Adrian GuggisbergUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Sep 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To assess the effect of these brain stimulation techniques on brain organization with non-invasive imaging.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cTBS | Active comparator | Device: cTBSA 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. |
| cathodal tDCS | Active comparator | Device: cathodal tDCSA 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. |
| sham stimulation | Sham comparator | Device: sham stimulationThis 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- epileptic seizures
- metallic objects in the brain
- presence of implants or neural stimulators
- pregnancy
- sleep deprivation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cTBSAlso: MagPro X100 | Device | cTBS |
| cathodal tDCSAlso: NeuroConn | Device | cathodal tDCS |
| sham stimulation | Device | sham stimulation |
Primary outcome
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.
Change in alpha-band coherence between the affected motor cortex and the rest of the brain
Time frame: Week 4
Calculated from electroencephalography recordings
7 secondary outcomes
Change in Fugl Meyer Upper Extremity Motor Score at week 4
Time frame: Week 4
Change in Fugl Meyer Upper Extremity Motor Score at week 8
Time frame: Week 8
Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain
Time frame: Week 4
Change in activity of daily life scale (motor activity log, MAL)
Time frame: Week 4
Change in activity of daily life scale (motor activity log, MAL)
Time frame: Week 8
Number of adverse events
Time frame: Week 4
Number of adverse events
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 23941616Rizk 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.
- Derived from this study: PubMed 29223708Nicolo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian G Guggisberg, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cTBS and cathodal tDCS in people with Stroke, run by Adrian Guggisberg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in compound motor score slope at week 4 (time frame: week 4 after treatment start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031107, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.