StrokeNCT02512289
Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation
A study testing tDCS (ELDITH) and RAT (REAplan) in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial summary
tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- tDCS (ELDITH) and RAT (REAplan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesBelgium
- Study dates
- 9 Jan 2014to 30 Jul 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stroke with at least slight deficit in upper limb
Who cannot join
- epilepsy
- contraindication to tDCS
- presence of metal in the head
- inability to understand/complete behavioural tasks
- chronic intake of alcohol or recreative drugs
- major health condition (e.g. terminal renal failure, instable heart failure etc …)
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
CHU Dinant-Godinne UCL
Mont Godinne
About this study
tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.
Read the detailed description
tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.
tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.
- Conditions
- Stroke
- Being tested
- tDCS (ELDITH) and RAT (REAplan)
- 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) and RAT (REAplan)Device
Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan
| Study group | Role | What they receive |
|---|---|---|
| Real stimulation | Active comparator | real tDCS associated with robot-assisted therapy (RAT) Receives: Device: tDCS (ELDITH) and RAT (REAplan) |
| Sham stimulation | Sham comparator | Sham tDCS associated with RAT Receives: Device: tDCS (ELDITH) and RAT (REAplan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Kinematics
Measured: kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Secondary outcomes (2)
Box and Block test
Measured: Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Purdue Pegboard Test
Measured: Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study start9 Jan 2014
- Primary completion9 Jan 2014
- Study completion30 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Mont-Godinne
- Responsible party
- Sponsor
- Investigators
- Thierry Lejeune, Professor, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512289
- Sponsor's protocol ID
- IONS-Gilliaux-03
- Status last verified
- Aug 2018
- First submitted
- 25 Aug 2014
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation
- ClinicalTrials.gov ID
- NCT02512289
- Acronym / sponsor ID
- IONS-Gilliaux-03
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- University Hospital of Mont-Godinne
- Study start
- 9 Jan 2014
- Primary completion
- 9 Jan 2014 (actual)
- Study completion
- 30 Jul 2015 (actual)
- First posted
- 30 Jul 2015 (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) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.
Detailed description
tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.
tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.
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) and RAT (REAplan)real tDCS associated with robot-assisted therapy (RAT) |
| Sham stimulation | Sham comparator | Device: tDCS (ELDITH) and RAT (REAplan)Sham tDCS associated with RAT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stroke with at least slight deficit in upper limb
Key exclusion criteria (7 listed)
- epilepsy
- contraindication to tDCS
- 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) and RAT (REAplan)Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan | Device | Real stimulation, Sham stimulation |
Primary outcome
Upper Limb Kinematics
Time frame: kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
2 secondary outcomes
Box and Block test
Time frame: Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Purdue Pegboard Test
Time frame: Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
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 24 Aug 2018.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Thierry Lejeune, Professor principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS (ELDITH) and RAT (REAplan) in people with Stroke, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites 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 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Upper Limb Kinematics (time frame: kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2018.