StrokeNCT01544699
Impact of Non-invasive Brain Stimulation on Motor Recuperation
A study testing tDCS (ELDITH) in people with Stroke, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb. 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)
- 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 2012to Jan 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 in superior or inferior limb
Who cannot join
- epilepsy
- contraindication to tDCS and/or to fMRI
- presence of metal in the head
- inability 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
tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.
Read the detailed description
tDCS will be used in chronic stroke patients to improve a variety of functions such as motor functions with superior or inferior limb.
tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after tDCS, as well as brain functional imaging data.
- Conditions
- Stroke
- Being tested
- tDCS (ELDITH)
- 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)Device
tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real stimulation | Active comparator | real tDCS (well, that's the way it is I am not gonna change it) Receives: Device: tDCS (ELDITH) |
| Sham | Sham comparator | sham tDCS Receives: Device: tDCS (ELDITH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in motor function before/after tDCS
Motor performance improvement with inferior or superior limb
Measured: Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2025 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Model description
- no change
- 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
- NCT01544699
- Sponsor's protocol ID
- B039201212957(2)
- Status last verified
- Jan 2024
- First submitted
- 10 Feb 2012
- Last updated
- 10 Jan 2024
- 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 33175411
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-invasive Brain Stimulation on Motor Recuperation
- ClinicalTrials.gov ID
- NCT01544699
- Acronym / sponsor ID
- B039201212957(2)
- 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 2012 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Mar 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.
tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.
Detailed description
tDCS will be used in chronic stroke patients to improve a variety of functions such as motor functions with superior or inferior limb.
tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after tDCS, 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
- Model description
- no change
| Arm | Type | Receives |
|---|---|---|
| Real stimulation | Active comparator | Device: tDCS (ELDITH)real tDCS (well, that's the way it is I am not gonna change it) |
| Sham | Sham comparator | Device: tDCS (ELDITH)sham tDCS |
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 in superior or inferior limb
Key exclusion criteria (8 listed)
- epilepsy
- contraindication to tDCS and/or to fMRI
- presence of metal in the head
- inability 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)tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation | Device | Real stimulation, Sham |
Primary outcome
change in motor function before/after tDCS
Time frame: Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks
Motor performance improvement with inferior or superior limb
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- 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 tDCS (ELDITH) 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 10 Jan 2024. 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 motor function before/after tDCS (time frame: Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks). 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 NCT01544699, which also lists 1 linked publication.
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 10 Jan 2024.