StrokeNCT01969097
Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
A study testing tDCS and Motor training in people with Stroke and Hemiparesis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- tDCS and Motor training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Dec 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic stroke (>6 months after stroke)
- age: 18 to 80 years
- non-hemorrhagic or hemorrhagic stroke
Who cannot join
- more than 1 stroke
- severe alcohol disease or drug abuse, severe psychiatric disease like depression or psychosis
- severe cognitive deficits
- severe untreated medical conditions
- other neurologic diseases
- severe microangiopathy
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.
- Conditions
- Stroke, Hemiparesis
- Being tested
- tDCS, Motor training
- Keywords
- Stroke, Hemiparesis, tDCS, Motor cortex
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
transcranial direct current stimulation (tDCS)
Motor trainingBehavioural
Motor training of the affected upper extremity (5 days, 25 min/day).
| Study group | Role | What they receive |
|---|---|---|
| Dual tDCS + motor training | Experimental | Motor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS). Receives: Device: tDCS; Behavioral: Motor training |
| Anodal tDCS + motor training | Active comparator | Motor training of the affected upper extremity combined with anodal tDCS. Receives: Device: tDCS; Behavioral: Motor training |
| Sham tDCS + motor training | Sham comparator | Motor training of the affected upper extremity combined with sham tDCS. Receives: Device: tDCS; Behavioral: Motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Function of the Affected Upper Extremity
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Measured: Change from baseline after 5 days (immediately after intervention)
Motor Function of the Affected Upper Extremity
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Measured: change from baseline after 3 months
Secondary outcomes (4)
Motor Function of the Affected Upper Extremity
Effects of dual tDCS + training vs anodal tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Measured: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Functional Magnetic Resonance Imaging
Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on task-specific activations and functional connectivity (measured by functional Magnetic Resonance Imaging, fMRI).
Measured: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Diffusion Tensor Imaging
Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on cerebral microstructure (measured by Diffusion Tensor Imaging, DTI).
Measured: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Transcranial Magnetic Stimulation
Effects of dual tDCS + training vs anodal tDCS + training vs sham tDCS + training on excitability of the primary motor cortex (measured by Motor Evoked Potentials, MEP, using Transcranial Magnetic Stimulation, TMS).
Measured: After 5 days vs baseline (before intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Robert Lindenberg, M.D., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969097
- Sponsor's protocol ID
- MotorCtx-Stroke-tDCS
- Status last verified
- Mar 2016
- First submitted
- 7 Oct 2013
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
PubMed 21068427Lindenberg R, Nachtigall L, Meinzer M, Sieg MM, Floel A. Differential effects of dual and unihemispheric motor cortex stimulation in older adults. J Neurosci. 2013 May 22;33(21):9176-83. doi: 10.1523/JNEUROSCI.0055-13.2013.
PubMed 23699528Floel A. tDCS-enhanced motor and cognitive function in neurological diseases. Neuroimage. 2014 Jan 15;85 Pt 3:934-47. doi: 10.1016/j.neuroimage.2013.05.098. Epub 2013 May 30.
PubMed 23727025Taud B, Lindenberg R, Darkow R, Wevers J, Hofflin D, Grittner U, Meinzer M, Floel A. Limited Add-On Effects of Unilateral and Bilateral Transcranial Direct Current Stimulation on Visuo-Motor Grip Force Tracking Task Training Outcome in Chronic Stroke. A Randomized Controlled Trial. Front Neurol. 2021 Nov 11;12:736075. doi: 10.3389/fneur.2021.736075. eCollection 2021.
PubMed 34858310Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Basics of Bihemispheric Motorcortex Stimulation After Stroke
- ClinicalTrials.gov ID
- NCT01969097
- Acronym / sponsor ID
- MotorCtx-Stroke-tDCS
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Hemiparesis, tDCS, Motor cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- First posted
- 25 Oct 2013 (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.
The aim of the study is to investigate whether the combination of bihemispheric ("dual") transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dual tDCS + motor training | Experimental | Device: tDCS, Behavioral: Motor trainingMotor training of the affected upper extremity combined with dual transcranial direct current stimulation (tDCS). |
| Anodal tDCS + motor training | Active comparator | Device: tDCS, Behavioral: Motor trainingMotor training of the affected upper extremity combined with anodal tDCS. |
| Sham tDCS + motor training | Sham comparator | Device: tDCS, Behavioral: Motor trainingMotor training of the affected upper extremity combined with sham tDCS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic stroke (>6 months after stroke)
- age: 18 to 80 years
- non-hemorrhagic or hemorrhagic stroke
Key exclusion criteria (7 listed)
- more than 1 stroke
- severe alcohol disease or drug abuse, severe psychiatric disease like depression or psychosis
- severe cognitive deficits
- severe untreated medical conditions
- other neurologic diseases
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 |
|---|---|---|
| tDCStranscranial direct current stimulation (tDCS) | Device | Anodal tDCS + motor training, Dual tDCS + motor training, Sham tDCS + motor training |
| Motor trainingMotor training of the affected upper extremity (5 days, 25 min/day). | Behavioural | Anodal tDCS + motor training, Dual tDCS + motor training, Sham tDCS + motor training |
Primary outcome
Motor Function of the Affected Upper Extremity
Time frame: Change from baseline after 5 days (immediately after intervention)
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
Motor Function of the Affected Upper Extremity
Time frame: change from baseline after 3 months
Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests).
4 secondary outcomes
Motor Function of the Affected Upper Extremity
Time frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Functional Magnetic Resonance Imaging
Time frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Diffusion Tensor Imaging
Time frame: After 5 days (immediately after intervention), after 3 months vs baseline (before intervention)
Transcranial Magnetic Stimulation
Time frame: After 5 days vs baseline (before intervention)
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 17 Mar 2016.
- Background: PubMed 21068427Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10.
- Background: PubMed 23699528Lindenberg R, Nachtigall L, Meinzer M, Sieg MM, Floel A. Differential effects of dual and unihemispheric motor cortex stimulation in older adults. J Neurosci. 2013 May 22;33(21):9176-83. doi: 10.1523/JNEUROSCI.0055-13.2013.
- Background: PubMed 23727025Floel A. tDCS-enhanced motor and cognitive function in neurological diseases. Neuroimage. 2014 Jan 15;85 Pt 3:934-47. doi: 10.1016/j.neuroimage.2013.05.098. Epub 2013 May 30.
- Derived from this study: PubMed 34858310Taud B, Lindenberg R, Darkow R, Wevers J, Hofflin D, Grittner U, Meinzer M, Floel A. Limited Add-On Effects of Unilateral and Bilateral Transcranial Direct Current Stimulation on Visuo-Motor Grip Force Tracking Task Training Outcome in Chronic Stroke. A Randomized Controlled Trial. Front Neurol. 2021 Nov 11;12:736075. doi: 10.3389/fneur.2021.736075. eCollection 2021.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
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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.
Robert Lindenberg, M.D. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Motor training in people with Stroke and Hemiparesis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 inclusion and 7 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 17 Mar 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 Germany. 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?
Motor Function of the Affected Upper Extremity (time frame: Change from baseline after 5 days (immediately after intervention)). 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 NCT01969097, which also lists 5 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 17 Mar 2016.