StrokeReSTIMNCT01500564
Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol): ReSTIM
A study testing anodal tDCS (device) Eldith DC-Stimulator in people with Stroke, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- anodal tDCS (device) Eldith DC-Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Jan 2012to 31 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must be between the ages of 18-90 and must not be pregnant.
- Patients volunteer to participate in the study, with a written informed consent signed
- Affiliation to a national health insurance program
- First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report
- Contralesional motor deficit
- Lesion sparing primary motor cortex
- Stroke onset >1 month and <6 months prior to study enrollment
Who cannot join
- Coexistent major neurological or psychiatric disease as to decrease number of confounders
- History of epilepsy before stroke (or episodes of seizures within the last six months)
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
- Subjects with global aphasia and deficits of comprehension
- Excessive pain in any joint of the paretic extremity (VAS>4)
- Contraindications to Tdcs : metal in the head, implanted brain medical devices
Show all 11Show fewer
- Coexistent major neurological or psychiatric disease as to decrease number of confounders
- A history of significant alcohol or drug abuse in the prior 6 months
- Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours
- Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de Lay-Saint-Christophe-Institut Régional de Médecine Physique et de Réadaptation
Lay-Saint-Christophe, 54690
Hospices Civils de Lyon- Hôpital Henry Gabrielle-Service de Médecine Physique et Réadaptation
Saint-Genis-Laval, 69235
About this study
Official title: Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).
Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.
This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.
- Conditions
- Stroke
- Being tested
- anodal tDCS (device) Eldith DC-Stimulator, Sham tDCS
- Keywords
- Stroke, transcranial direct current stimulation (tDCS), motor function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal tDCS (device) Eldith DC-StimulatorDevice
Also called Eldith DC-Stimulator (CE certified)
tDCS applied to the motor cortex every day of two consecutive weeks (10 sessions) at 1 mA during 20 minutes. Conductive rubber covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 100 seconds.
Sham tDCSDevice
Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS and motor training: sham comparator | Sham comparator | Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
Intervention: placebo tDCS Other: Motor Training Receives: Device: Sham tDCS |
| Anodal tDCS and motor training: experimental | Experimental | Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
Interventions:
* Device: anodal tDCS
* Other: motor Training during physiotherapy Receives: Device: anodal tDCS (device) Eldith DC-Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke
Main primary outcome is change in score between the baseline session score and day 32.
Measured: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Secondary outcomes (6)
Functional independence scale (MIF)
We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
Measured: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Motor Activity Log (MAL)
We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
Measured: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Jebsen Taylor Hand function test (JTT)
We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
Measured: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Box and block test (BBT)
We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
Measured: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Modified Ashworth Scale
We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
Measured: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Testing motor MRC
We are looking for a change in scores between the baseline session score, and those collected during each follow-up session.
Measured: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start2 Jan 2012
- Primary completion31 Jul 2015
- Study completion31 Jul 2015
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.
- More trials run by Hospices Civils de LyonThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie JACQUIN-COURTOIS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500564
- Sponsor's protocol ID
- 2010.635
- Acronym
- ReSTIM
- Status last verified
- Jan 2018
- First submitted
- 22 Dec 2011
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
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 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Interest of Non Invasive Brain Stimulation During Physiotherapy at a Subacute Phase Post Stroke (Anodal Protocol).
- ClinicalTrials.gov ID
- NCT01500564
- Acronym / sponsor ID
- ReSTIM / 2010.635
- Conditions
- Stroke
- Keywords
- Stroke, transcranial direct current stimulation (tDCS), motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Jan 2012 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 28 Dec 2011 (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.
Previous research that utilises single sessions of transcranial direct current stimulation (tDCS) have demonstrated functional improvements. However these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. In these studies, tDCS is typically applied with the goal of adaptively enhancing functional activation of pathologically under-active tissue or suppressing pathologically over-active tissue. Interestingly, a small body of evidence is now emerging to indicate that tDCS can improve learning/memory functions in healthy controls. The goal of this study is to test if the application of tDCS could enhance learning and/or memory for physiotherapy rehabilitation, which may in turn lead to correspondingly greater motor improvement. Patients at a subacute stage (1 to 6 month post stroke) will attend for 10 consecutive daily sessions of tDCS.
This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS and motor training: sham comparator | Sham comparator | Device: Sham tDCSParticipants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks). Intervention: placebo tDCS Other: Motor Training |
| Anodal tDCS and motor training: experimental | Experimental | Device: anodal tDCS (device) Eldith DC-StimulatorParticipants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks). Interventions: * Device: anodal tDCS * Other: motor Training during physiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects must be between the ages of 18-90 and must not be pregnant.
- Patients volunteer to participate in the study, with a written informed consent signed
- Affiliation to a national health insurance program
- First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report
- Contralesional motor deficit
Key exclusion criteria (11 listed)
- Coexistent major neurological or psychiatric disease as to decrease number of confounders
- History of epilepsy before stroke (or episodes of seizures within the last six months)
- Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
- Subjects with global aphasia and deficits of comprehension
- Excessive pain in any joint of the paretic extremity (VAS>4)
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 |
|---|---|---|
| anodal tDCS (device) Eldith DC-StimulatorAlso: Eldith DC-Stimulator (CE certified)tDCS applied to the motor cortex every day of two consecutive weeks (10 sessions) at 1 mA during 20 minutes. Conductive rubber covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 100 seconds. | Device | Anodal tDCS and motor training: experimental |
| Sham tDCSParticipants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks). | Device | Sham tDCS and motor training: sham comparator |
Primary outcome
Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke
Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Main primary outcome is change in score between the baseline session score and day 32.
6 secondary outcomes
Functional independence scale (MIF)
Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Motor Activity Log (MAL)
Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Jebsen Taylor Hand function test (JTT)
Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Box and block test (BBT)
Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Modified Ashworth Scale
Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
Testing motor MRC
Time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.
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 31 Jan 2018.
- 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.
Sophie JACQUIN-COURTOIS, MD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal tDCS (device) Eldith DC-Stimulator in people with Stroke, run by Hospices Civils de Lyon 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 7 inclusion and 11 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 31 Jan 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 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?
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?
Fugl Meyer Assessment (Upper extremity) of motor recovery following stroke (time frame: assessed at one baseline session (day 4), and then again immediately following the last day of the intervention (day 18), 2 weeks (day 32), 1 month, 3 months and 6 months later.). 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 NCT01500564, 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 31 Jan 2018.