StrokeMADECCSNCT03092570
Manual Dexterity Control After Cerebellar Stimulation
A study testing With stimulation and No stimulation in people with Stroke, run by Centre Hospitalier St Anne at 2 sites in France.
Trial summary
This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- With stimulation and No stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jun 2017to Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed
- Affiliated to the French health insurance or similar organisation
- Signed informed consent
- Clinical examination
- For "Post-AVC patients" :
- at least 18 years old
Show all 9Show fewer
- completed the Moberg Pick-up test with a minimum score of 20 secondes For "Young healthy" group
- 18 = or > years = or <30 For "Older healthy" group
- 50 > or = years = or < 80
Who cannot join
- Metallic implant in the head
- Pacemaker, or other electronic implanted devices
- Other central neurological disease
- Pregnancy, breast feeding
- Previous history of neurosurgery or seizures or 1st degree relative with history of seizures
- History of medical neurological or psychiatric disorders
Show all 14Show fewer
- Participation to another study using cerebral stimulation
- History of bi-polar or recurring depressive disorders
- Planned carotid revascularization, severe caridac disease
- Kidney failure (transaminase > 2 times normal value)
- Other invalidating condition or deficiency interfering with the study
- For "Post-AVC patients" :
- NIHSS score > 20
- Cerebellar ischemic CVA
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre de Recherche Clinique (CRC) - CHSA
Paris, 75014
Macarena CUENCA, MD, m.cuenca@ch-sainte-anne.fr
Cecile Bergot, 00 33 1 45 65 84 90, c.bergot@ch-sainte-anne.fr
- Not yet recruiting
Service de Médecine Physique et Rédaptation
Paris, 75014
Florence COLLE, MD, 00331 45 65 62 00, f.colle@ch-sainte-anne.fr
Marie GODARD, 00 33 1 45 65 77 28, marie.godard@aphp.fr
About this study
Official title: Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients
This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.
Read the detailed description
Cerebrovascular accidents (CVA) are the first cause of acquired disability in France. Despite rehabilitation interventions, a great proportion of patients suffers from motor disability in the upper limb. Recently, several studies have shown that post CVA patients exhibit great neural plasticity as a direct consequence of their condition.
Interestingly, the transcranial direct current stimulation (tDCS) is a non-invasive electro stimulation technique that allows for a modulation of cerebral activity. It has been shown that when applied to the cerebellum, tDCS increases learning performances of healthy subjects. Yet, motor rehabilitation after a CVA highly relies on motor (re)learning. The cerebellar tDCS thus appear as a promising method to enhance the performance of post-CVA motor learning and consequently the benefits of post-CVA rehabilitation.
The current study aims to promote the post CVA neural plasticity by using the tDCS in order to enhance motor learning of the upper limb.
- Conditions
- Stroke
- Being tested
- With stimulation, No stimulation
- Keywords
- Motor learning, stroke, tDCS, upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
With stimulationDevice
ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions
No stimulationDevice
ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.
| Study group | Role | What they receive |
|---|---|---|
| tDCS Post-CVA | Experimental | The participants will get a 20min stimulation at a maximal intensity of 2mA Receives: Device: With stimulation |
| Sham Post-CVA | Sham comparator | The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task Receives: Device: No stimulation |
| tDCS Young Healthy | Experimental | The participants will get a 20min stimulation at a maximal intensity of 2mA Receives: Device: With stimulation |
| Sham Young Healthy | Sham comparator | The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task Receives: Device: No stimulation |
| tDCS Older Healthy | Experimental | The participants will get a 20min stimulation at a maximal intensity of 2mA Receives: Device: With stimulation |
| Sham Older Healthy | Sham comparator | The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task Receives: Device: No stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force control
Measurement in Newton of the force applied by each finger.
Measured: Day 1
Force control
Measurement in Newton of the force applied by each finger.
Measured: Day 2
Force control
Measurement in Newton of the force applied by each finger.
Measured: Day 3
Force control
Measurement in Newton of the force applied by each finger.
Measured: Day 10
Overflow
Measurement in ms of the involuntary finger movements.
Measured: Day 1
Overflow
Measurement in ms of the involuntary finger movements.
Measured: Day 2
Overflow
Measurement in ms of the involuntary finger movements.
Measured: Day 3
Overflow
Measurement in ms of the involuntary finger movements.
Measured: Day 10
Secondary outcomes (12)
Moberg Pick-up Test
Assessment of the functionality of the hand. One score will be given at the end of the test.
Measured: Day 1
Moberg Pick-up Test
Assessment of the functionality of the hand. One score will be given at the end of the test.
Measured: Day 2
Moberg Pick-up Test
Assessment of the functionality of the hand. One score will be given at the end of the test.
Measured: Day 3
Moberg Pick-up Test
Assessment of the functionality of the hand. One score will be given at the end of the test.
Measured: Day 10
Action Research Arm Test
Assessment of the upper limb mobility. One score will be given at the end of the test
Measured: Day 1
Action Research Arm Test
Assessment of the upper limb mobility. One score will be given at the end of the test
Measured: Day 2
Action Research Arm Test
Assessment of the upper limb mobility. One score will be given at the end of the test
Measured: Day 3
Action Research Arm Test
Assessment of the upper limb mobility. One score will be given at the end of the test
Measured: Day 10
Finger time release
Time needed to release the finger force when needed (in ms).
Measured: Day 1
Finger time release
Time needed to release the finger force when needed (in ms).
Measured: Day 2
Finger time release
Time needed to release the finger force when needed (in ms).
Measured: Day 3
Finger time release
Time needed to release the finger force when needed (in ms).
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start12 Jun 2017
- Primary completionApr 2019 (estimated)
- Study completionJun 2019 (estimated)
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence COLLE, MD, Principal investigator, CHSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092570
- Sponsor's protocol ID
- D16-P03
- Acronym
- MADECCS
- Status last verified
- Oct 2017
- First submitted
- 15 Feb 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients
- ClinicalTrials.gov ID
- NCT03092570
- Acronym / sponsor ID
- MADECCS / D16-P03
- Conditions
- Stroke
- Keywords
- Motor learning, stroke, tDCS, upper limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 28 Mar 2017 (actual)
- 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.
This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.
Detailed description
Cerebrovascular accidents (CVA) are the first cause of acquired disability in France. Despite rehabilitation interventions, a great proportion of patients suffers from motor disability in the upper limb. Recently, several studies have shown that post CVA patients exhibit great neural plasticity as a direct consequence of their condition.
Interestingly, the transcranial direct current stimulation (tDCS) is a non-invasive electro stimulation technique that allows for a modulation of cerebral activity. It has been shown that when applied to the cerebellum, tDCS increases learning performances of healthy subjects. Yet, motor rehabilitation after a CVA highly relies on motor (re)learning. The cerebellar tDCS thus appear as a promising method to enhance the performance of post-CVA motor learning and consequently the benefits of post-CVA rehabilitation.
The current study aims to promote the post CVA neural plasticity by using the tDCS in order to enhance motor learning of the upper limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| tDCS Post-CVA | Experimental | Device: With stimulationThe participants will get a 20min stimulation at a maximal intensity of 2mA |
| Sham Post-CVA | Sham comparator | Device: No stimulationThe tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task |
| tDCS Young Healthy | Experimental | Device: With stimulationThe participants will get a 20min stimulation at a maximal intensity of 2mA |
| Sham Young Healthy | Sham comparator | Device: No stimulationThe tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task |
| tDCS Older Healthy | Experimental | Device: With stimulationThe participants will get a 20min stimulation at a maximal intensity of 2mA |
| Sham Older Healthy | Sham comparator | Device: No stimulationThe tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Right-handed
- Affiliated to the French health insurance or similar organisation
- Signed informed consent
- Clinical examination
- at least 18 years old
Key exclusion criteria (14 listed)
- Metallic implant in the head
- Pacemaker, or other electronic implanted devices
- Other central neurological disease
- Pregnancy, breast feeding
- Previous history of neurosurgery or seizures or 1st degree relative with history of seizures
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 |
|---|---|---|
| With stimulationramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions | Device | tDCS Older Healthy, tDCS Post-CVA, tDCS Young Healthy |
| No stimulationramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA. | Device | Sham Older Healthy, Sham Post-CVA, Sham Young Healthy |
Primary outcome
Force control
Time frame: Day 1
Measurement in Newton of the force applied by each finger.
Force control
Time frame: Day 2
Measurement in Newton of the force applied by each finger.
Force control
Time frame: Day 3
Measurement in Newton of the force applied by each finger.
Force control
Time frame: Day 10
Measurement in Newton of the force applied by each finger.
Overflow
Time frame: Day 1
Measurement in ms of the involuntary finger movements.
Overflow
Time frame: Day 2
Measurement in ms of the involuntary finger movements.
Overflow
Time frame: Day 3
Measurement in ms of the involuntary finger movements.
Overflow
Time frame: Day 10
Measurement in ms of the involuntary finger movements.
12 secondary outcomes
Moberg Pick-up Test
Time frame: Day 1
Moberg Pick-up Test
Time frame: Day 2
Moberg Pick-up Test
Time frame: Day 3
Moberg Pick-up Test
Time frame: Day 10
Action Research Arm Test
Time frame: Day 1
Action Research Arm Test
Time frame: Day 2
Action Research Arm Test
Time frame: Day 3
Action Research Arm Test
Time frame: Day 10
Finger time release
Time frame: Day 1
Finger time release
Time frame: Day 2
Finger time release
Time frame: Day 3
Finger time release
Time frame: Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
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.
Florence COLLE, MD principal investigator
CHSA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With stimulation and No stimulation in people with Stroke, run by Centre Hospitalier St Anne at 2 sites in France.
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Oct 2017. 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 France. 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?
Contact Marion Verneau, PhD (+33140788663, mverneau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force control (time frame: Day 1). The study lists 8 primary outcomes in all. 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 19 Oct 2017.