StrokeNIBSstrokeNCT01503073
Noninvasive Brain Stimulation for Stroke
A study testing tdcs (ELDITH, Neuroconn, Ilmenau, Germany) in people with Stroke, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2008to 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 90 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
- unability to understand / complete behavioural tasks
- chronic intake of alcohol or recreative drugs
- major health condition
- presence of pacemaker
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Brain Stimulation for Stroke Improvement
Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.
Read the detailed description
Noninvasive brain stimulations (NIBS) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ...
NIBS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after NIBS, as well as brain functional imaging data.
- Conditions
- Stroke
- Being tested
- tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tdcs (ELDITH, Neuroconn, Ilmenau, Germany)Device
transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real stimulation | Active comparator | real NIBS Receives: Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany) |
| Sham stimulation | Sham comparator | sham NIBS Receives: Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in function before/after tDCS
any brain function impaired by stroke
Measured: Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months
Secondary outcomes (1)
change in neuroimaging and neurophysiological before/after tDCS
- noninvasive neuroimaging : brain activity studied by means of fMRI
- noninvasive neurophysiological measure : TMS, EEG,evoked potentials, EMG
Measured: Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startJan 2008
- 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
- 200 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
- NCT01503073
- Sponsor's protocol ID
- B03920073136
- Acronym
- NIBSstroke
- Status last verified
- May 2023
- First submitted
- 23 Dec 2011
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Elsner 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 33175411Lefebvre S, Thonnard JL, Laloux P, Peeters A, Jamart J, Vandermeeren Y. Single session of dual-tDCS transiently improves precision grip and dexterity of the paretic hand after stroke. Neurorehabil Neural Repair. 2014 Feb;28(2):100-10. doi: 10.1177/1545968313478485. Epub 2013 Mar 13.
PubMed 23486918
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
- Noninvasive Brain Stimulation for Stroke Improvement
- ClinicalTrials.gov ID
- NCT01503073
- Acronym / sponsor ID
- NIBSstroke / B03920073136
- Conditions
- Stroke
- Keywords
- stroke
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 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 will be used in acute and chronic stroke patients to improve a variety of functions.
Detailed description
Noninvasive brain stimulations (NIBS) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ...
NIBS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after NIBS, as well as brain functional imaging data.
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 stimulation | Active comparator | Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)real NIBS |
| Sham stimulation | Sham comparator | Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)sham NIBS |
Who may qualify
- Ages
- 18 to 90 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
- unability to understand / complete behavioural tasks
- chronic intake of alcohol or recreative 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 |
|---|---|---|
| tdcs (ELDITH, Neuroconn, Ilmenau, Germany)transcranial direct current stimulation | Device | Real stimulation, Sham stimulation |
Primary outcome
change in function before/after tDCS
Time frame: Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months
any brain function impaired by stroke
1 secondary outcome
change in neuroimaging and neurophysiological before/after tDCS
Time frame: Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months
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 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.
- Derived from this study: PubMed 23486918Lefebvre S, Thonnard JL, Laloux P, Peeters A, Jamart J, Vandermeeren Y. Single session of dual-tDCS transiently improves precision grip and dexterity of the paretic hand after stroke. Neurorehabil Neural Repair. 2014 Feb;28(2):100-10. doi: 10.1177/1545968313478485. Epub 2013 Mar 13.
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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 tdcs (ELDITH, Neuroconn, Ilmenau, Germany) in people with Stroke, 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?
change in function before/after tDCS (time frame: Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months). 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 NCT01503073, 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; AzTrials last refreshed its copy on 29 Oct 2026.