StrokeNCT01519843
Post Stroke Motor Learning
A study testing transcranial direct current stimulation tDCS and transcranial magnetic stimulation TMS in people with Stroke and Hemiparesis, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning. Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- transcranial direct current stimulation tDCS and transcranial magnetic stimulation TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Dec 2030
- 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stroke with at least slight deficit
Who cannot join
- epilepsy
- contraindication to tDCS and/or to fMRI
- presence of metal in the head
- inability to understand / complete behavioral tasks
- chronic intake of alcohol or recreational drugs
- major health condition
- presence of pacemaker (for the fMRI part only)
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation
Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.
Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.
Read the detailed description
transcranial direct current stimulation will be used for NIBS
- Conditions
- Stroke, Hemiparesis
- Being tested
- transcranial direct current stimulation tDCS, transcranial magnetic stimulation TMS
- Keywords
- stroke
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation tDCSDevice
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
transcranial magnetic stimulation TMSDevice
TMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand
| Study group | Role | What they receive |
|---|---|---|
| Real | Active comparator | Real tDCS Receives: Device: transcranial direct current stimulation tDCS; Device: transcranial magnetic stimulation TMS |
| sham | Placebo comparator | Sham tDCS Receives: Device: transcranial direct current stimulation tDCS; Device: transcranial magnetic stimulation TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor learning improvement with tDCS
performance on a motor skill learning task and on different commonly used task (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT ,...) were measured to explore the impact of tDCS on these parameters
Measured: Improvement on motor learning were recorded from baseline to 4 weeks after the intervention
Secondary outcomes (2)
Neuroimaging
Does cerebral mechanisms underlying motor learning differ from healthy subject to stroke patients?
Measured: before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)
Neurophysiological outcome measure
measure of brain excitability and connectivity with TMS (single and paired pulse)
Measured: start of session 5min before motor learning, just at the end of the motor learning, after 30 min of motor learning, after 60 min of motor learning, Recall test at 1,2,3,4 weeks after the day of intervention (with or without tDCS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionDec 2025 (estimated)
- Study completionDec 2030 (estimated)
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Yves Vandermeeren, MD, PhD, University Hospital of Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519843
- Sponsor's protocol ID
- B039201212957
- Status last verified
- May 2023
- First submitted
- 19 Jan 2012
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Riga A, Gathy E, Ghinet M, De Laet C, Bihin B, Regnier M, Leeuwerck M, De Coene B, Dricot L, Herman B, Edwards MG, Vandermeeren Y. Evidence of Motor Skill Learning in Acute Stroke Patients Without Lesions to the Thalamus and Internal Capsule. Stroke. 2022 Jul;53(7):2361-2368. doi: 10.1161/STROKEAHA.121.035494. Epub 2022 Mar 21.
PubMed 35311345Elsner 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT01519843
- Acronym / sponsor ID
- B039201212957
- Conditions
- Stroke, Hemiparesis
- Keywords
- stroke
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Jan 2012 (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.
Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.
Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.
Detailed description
transcranial direct current stimulation will be used for NIBS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real | Active comparator | Device: transcranial direct current stimulation tDCS, Device: transcranial magnetic stimulation TMSReal tDCS |
| sham | Placebo comparator | Device: transcranial direct current stimulation tDCS, Device: transcranial magnetic stimulation TMSSham tDCS |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stroke with at least slight deficit
Key exclusion criteria (8 listed)
- epilepsy
- contraindication to tDCS and/or to fMRI
- presence of metal in the head
- inability to understand / complete behavioral tasks
- chronic intake of alcohol or recreational drugs
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 |
|---|---|---|
| transcranial direct current stimulation tDCStdcs (ELDITH, Neuroconn, Ilmenau, Germany) | Device | Real, sham |
| transcranial magnetic stimulation TMSTMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand | Device | Real, sham |
Primary outcome
Motor learning improvement with tDCS
Time frame: Improvement on motor learning were recorded from baseline to 4 weeks after the intervention
performance on a motor skill learning task and on different commonly used task (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT ,...) were measured to explore the impact of tDCS on these parameters
2 secondary outcomes
Neuroimaging
Time frame: before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)
Neurophysiological outcome measure
Time frame: start of session 5min before motor learning, just at the end of the motor learning, after 30 min of motor learning, after 60 min of motor learning, Recall test at 1,2,3,4 weeks after the day of intervention (with or without tDCS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 35311345Riga A, Gathy E, Ghinet M, De Laet C, Bihin B, Regnier M, Leeuwerck M, De Coene B, Dricot L, Herman B, Edwards MG, Vandermeeren Y. Evidence of Motor Skill Learning in Acute Stroke Patients Without Lesions to the Thalamus and Internal Capsule. Stroke. 2022 Jul;53(7):2361-2368. doi: 10.1161/STROKEAHA.121.035494. Epub 2022 Mar 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation tDCS and transcranial magnetic stimulation TMS in people with Stroke and Hemiparesis, run by University Hospital of Mont-Godinne at 1 site in Belgium.
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 1 inclusion and 8 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: paused, as of the sponsor's last update on 9 May 2023. 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 Belgium. 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?
Results are not available in the source record.
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 learning improvement with tDCS (time frame: Improvement on motor learning were recorded from baseline to 4 weeks after the intervention). 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 NCT01519843, 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 9 May 2023.