StroketDCS(HE)NCT02109796
Effects of tDCS on Quadriceps Strength After Stroke
A study testing transcranial Direct current stimulation in people with Stroke, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- transcranial Direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 19 Feb 2015to 30 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written consent
- hemiparetic patient after stroke in chronic phase (> 6 months)
- capacity to walk with or without technical assistance
- following rehabilitation program for lower limbs
Who cannot join
- patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia
- previous orthopedic surgery in paretic lower limb (<6 moths)
- usual tDCS contraindications
- pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.
Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.
We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.
- Conditions
- Stroke
- Being tested
- transcranial Direct current stimulation
- Keywords
- tDCS, Stroke, Force, Spasticity, Gait, EMG, Isokinetic
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hemiplegic patient | Experimental | anodal transcranial direct current stimulation Receives: Device: transcranial Direct current stimulation |
| patient control | Sham comparator | Sham transcranial direct current stimulation Receives: Device: transcranial Direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum voluntary isometric strength of knee extensors
The maximum voluntary isometric strength of paretic knee extensors will be evaluated with a isokinetic dynamometer, which measure peak torque.
Measured: 2 hours
Secondary outcomes (5)
Resistive peak torque during passive knee flexion
Measured: 2h
Angle related to the resistive peak torque generation of the knee extensors
Measured: 2h
Amplitude of the interpolation twitch
Measured: 2h
EMG activation of the knee flexors and extensors during the strength evaluations (active and passive)
Measured: 2h
Functional evaluation of the gait performance and balance
Measured: 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study start19 Feb 2015
- Primary completion28 Nov 2016
- Study completion30 Apr 2017
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Garches
- Responsible party
- Sponsor
- Investigators
- Roche Nicolas, MD PH, Principal investigator, Raymond Poincaré HospitalBensmail Djamel, MD PH, Principal investigator, Raymond Poincare Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109796
- Sponsor's protocol ID
- 2014-A00219-38
- Acronym
- tDCS(HE)
- Status last verified
- Nov 2017
- First submitted
- 8 Apr 2014
- Last updated
- 14 Nov 2017
- 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 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.
- ClinicalTrials.gov ID
- NCT02109796
- Acronym / sponsor ID
- tDCS(HE) / 2014-A00219-38
- Conditions
- Stroke
- Keywords
- tDCS, Stroke, Force, Spasticity, Gait, EMG, Isokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Fondation Garches
- Study start
- 19 Feb 2015 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 10 Apr 2014 (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 studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.
We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemiplegic patient | Experimental | Device: transcranial Direct current stimulationanodal transcranial direct current stimulation |
| patient control | Sham comparator | Device: transcranial Direct current stimulationSham transcranial direct current stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written consent
- hemiparetic patient after stroke in chronic phase (> 6 months)
- capacity to walk with or without technical assistance
- following rehabilitation program for lower limbs
Key exclusion criteria (4 listed)
- patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia
- previous orthopedic surgery in paretic lower limb (<6 moths)
- usual tDCS contraindications
- pregnant woman
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 |
|---|---|---|
| transcranial Direct current stimulation | Device | hemiplegic patient, patient control |
Primary outcome
maximum voluntary isometric strength of knee extensors
Time frame: 2 hours
The maximum voluntary isometric strength of paretic knee extensors will be evaluated with a isokinetic dynamometer, which measure peak torque.
5 secondary outcomes
Resistive peak torque during passive knee flexion
Time frame: 2h
Angle related to the resistive peak torque generation of the knee extensors
Time frame: 2h
Amplitude of the interpolation twitch
Time frame: 2h
EMG activation of the knee flexors and extensors during the strength evaluations (active and passive)
Time frame: 2h
Functional evaluation of the gait performance and balance
Time frame: 2h
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 14 Nov 2017.
- 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.
Roche Nicolas, MD PH principal investigator
Raymond Poincaré Hospital
Bensmail Djamel, MD PH principal investigator
Raymond Poincare Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct current stimulation in people with Stroke, run by Centre d'Investigation Clinique et Technologique 805 at 1 site 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 4 inclusion and 4 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 14 Nov 2017. 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 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?
maximum voluntary isometric strength of knee extensors (time frame: 2 hours). 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 NCT02109796, 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 14 Nov 2017.