Gait DisordersPhase 4HEMILOCOSTICORNCT02134158
Impact of tDCS on Locomotion and Equilibrium in Hemiplegic Patients
A Phase 4 study of Gait Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gait Disorders
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2014to Sep 2018
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults
- Unilateral stroke
- More than 6 months after stroke
- Ability to walk during 10 minutes without stopping
- Informed consent signed
Who cannot join
- Patient with pacemaker
- Claustrophobia (unable to perform a magnetic resonance imaging analysis)
- Patient with severe aphasia or severe cognitive disorder interfering the follow-up of the trial
- Neuro-orthopedic surgery history in the last 6 months on the studied paretic lower limb
- Epilepsy history in the last year
- Lack of medical insurance
Show all 16Show fewer
- Adult patient under the care of a guardian
- Patient with progressive concomitant disease
- Patient with deep brain stimulation treatment (implantation of medical device)
- Patient with implantation of Intracranial metallic clip
- Patient with implantation of Intracranial stent
- Patient with implantation of ventriculoperitoneal derivation
- Patient with implantation of intracerebral or ocular prosthetic materials
- Patient with ferro-magnetic foreign object
- Patient with cochlear implant
- Patient with implantable cardioverter-defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Transcranial Direct Current Stimulation (tDCS) on Locomotion and Bipedal Equilibrium in Hemiplegic Patients: a Crossover Randomized Controlled Trial
The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients.
Read the detailed description
This is a pilot prospective randomised crossover double blind study. 40 patients will be enrolled in two sites, with 20 patients each site.
The duration of this study is planned to be 25 months: 24 months will be for enrollment and 1 month for the follow-up.
The follow-up of patient comprises 3 visits, will be extended to 28 days for each patient:
- V1: inclusion visit:
After obtained an informed consent signed, the following analysis will be realized: a clinical assessment, quantify analysis of walking using 3D motion analysis system, assessment of equilibrium using force plate and functional abilities.
The patient will record him-self clinical scales and will respond auto-evaluation questionnaires. A cerebral magnetic resonance imaging and a blood collection of 5 ml will also be realized.
- V2-V3 (Locomotion /equilibrium assessment visit):
V2 and V3 will begin with tDCS experimental visit (EV) or tDCS placebo visit (PV), the visit order for each patient will be defined by randomization result.
During the 2 visits, the tDCS will be placed on the scalp of the patient. The anode will be placed at the hot spot of the tibialis anterior motor cortex area on the damage hemisphere, and the cathode will be placed at the controlateral orbit. The intensity of stimulation will be 2 mA.
In tDCS experimental visit, the stimulation will last 30 minutes. In tDCS placebo visit, the duration of the stimulation will only be 120 seconds, with the identical other conditions.
Before the beginning of the stimulation, a clinical assessment, a functional gait related activities evaluation and a 3D gait motion analysis associated with an evaluation of the equilibrium will be performed.
During the stimulation period, the gait and the equilibrium assessments, using 3D motion analysis will be done.
After the stimulation, the evaluations such as clinical, functional and motion analysis will be realized again.
The tDCS experimental visit and the tDCS placebo visit will be spaced one week.
- Conditions
- Gait Disorders
- Being tested
- anodal tDCS and sham tDCS stimulations
- Keywords
- tDCS, gait disorders, equilibrium, hemiplegic, stroke
- Medical subject headings
- Mobility Limitation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal tDCS and sham tDCS stimulationsDevice
Two conditions will be tested in randomized order: 2 arms in the first one anodal tDCS and then sham tDCS. In the other arm sham tDCS and then anodal tDCS.
All the investigations will associate with clinical, functional and 3D motion analysis assessments.
| Study group | Role | What they receive |
|---|---|---|
| sham and then anodal | Experimental | visit 2 sham stimulation (120 seconds) and visit 3 anodal stimulation (30 minutes) Receives: Device: anodal tDCS and sham tDCS stimulations |
| anodal and then sham | Experimental | visit 2 anodal stimulation (30 minutes) and visit 3 sham stimulation (120 seconds) Receives: Device: anodal tDCS and sham tDCS stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify of variability of the center-of-mass movement
Variability of the center-of-mass will be quantified during walking analysis and equilibrium assessment, for experimental and placebo visits (before, during and after stimulation) (V2 and V3) as well as in inclusion visit (V1).
Measured: 30 minutes
Secondary outcomes (3)
Symmetry index calculating
Symmetry index of the spatio-temporal parameters of gait Calculating methods of the symmetry: using the robinson index
Measured: 30 Minutes
Continuous relative phase
Assessment of the inter-segment coordination of the thigh-leg and leg-foot using the continuous relative phase.
Measured: 30 Minutes
Functional data
Time of climbing and descending 10 stairs of 11 cm Timed Up and Go test Box and Block Test
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study start10 Jul 2014
- Primary completion5 Aug 2016
- Study completionSep 2018
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 Gait DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, MD, PhD, Principal investigator, Laboratory of Movement Analysis, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134158
- Sponsor's protocol ID
- P120135 / AOM12126
- Other IDs
- 2013-A00952-43
- Acronym
- HEMILOCOSTICOR
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2013
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.
PubMed 29061169
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Direct Current Stimulation (tDCS) on Locomotion and Bipedal Equilibrium in Hemiplegic Patients: a Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02134158
- Acronym / sponsor ID
- HEMILOCOSTICOR / P120135 / AOM12126
- Conditions
- Gait Disorders
- Keywords
- tDCS, gait disorders, equilibrium, hemiplegic, stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jul 2014 (actual)
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 9 May 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.
The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients.
Detailed description
This is a pilot prospective randomised crossover double blind study. 40 patients will be enrolled in two sites, with 20 patients each site.
The duration of this study is planned to be 25 months: 24 months will be for enrollment and 1 month for the follow-up.
The follow-up of patient comprises 3 visits, will be extended to 28 days for each patient:
- V1: inclusion visit:
After obtained an informed consent signed, the following analysis will be realized: a clinical assessment, quantify analysis of walking using 3D motion analysis system, assessment of equilibrium using force plate and functional abilities.
The patient will record him-self clinical scales and will respond auto-evaluation questionnaires. A cerebral magnetic resonance imaging and a blood collection of 5 ml will also be realized.
- V2-V3 (Locomotion /equilibrium assessment visit):
V2 and V3 will begin with tDCS experimental visit (EV) or tDCS placebo visit (PV), the visit order for each patient will be defined by randomization result.
During the 2 visits, the tDCS will be placed on the scalp of the patient. The anode will be placed at the hot spot of the tibialis anterior motor cortex area on the damage hemisphere, and the cathode will be placed at the controlateral orbit. The intensity of stimulation will be 2 mA.
In tDCS experimental visit, the stimulation will last 30 minutes. In tDCS placebo visit, the duration of the stimulation will only be 120 seconds, with the identical other conditions.
Before the beginning of the stimulation, a clinical assessment, a functional gait related activities evaluation and a 3D gait motion analysis associated with an evaluation of the equilibrium will be performed.
During the stimulation period, the gait and the equilibrium assessments, using 3D motion analysis will be done.
After the stimulation, the evaluations such as clinical, functional and motion analysis will be realized again.
The tDCS experimental visit and the tDCS placebo visit will be spaced one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham and then anodal | Experimental | Device: anodal tDCS and sham tDCS stimulationsvisit 2 sham stimulation (120 seconds) and visit 3 anodal stimulation (30 minutes) |
| anodal and then sham | Experimental | Device: anodal tDCS and sham tDCS stimulationsvisit 2 anodal stimulation (30 minutes) and visit 3 sham stimulation (120 seconds) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults
- Unilateral stroke
- More than 6 months after stroke
- Ability to walk during 10 minutes without stopping
- Informed consent signed
Key exclusion criteria (16 listed)
- Patient with pacemaker
- Claustrophobia (unable to perform a magnetic resonance imaging analysis)
- Patient with severe aphasia or severe cognitive disorder interfering the follow-up of the trial
- Neuro-orthopedic surgery history in the last 6 months on the studied paretic lower limb
- Epilepsy history in the last year
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 and sham tDCS stimulationsTwo conditions will be tested in randomized order: 2 arms in the first one anodal tDCS and then sham tDCS. In the other arm sham tDCS and then anodal tDCS. All the investigations will associate with clinical, functional and 3D motion analysis assessments. | Device | anodal and then sham, sham and then anodal |
Primary outcome
Quantify of variability of the center-of-mass movement
Time frame: 30 minutes
Variability of the center-of-mass will be quantified during walking analysis and equilibrium assessment, for experimental and placebo visits (before, during and after stimulation) (V2 and V3) as well as in inclusion visit (V1).
3 secondary outcomes
Symmetry index calculating
Time frame: 30 Minutes
Continuous relative phase
Time frame: 30 Minutes
Functional data
Time frame: 30 minutes
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 13 Mar 2019.
- Derived from this study: PubMed 29061169Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.
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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.
Nicolas ROCHE, MD, PhD principal investigator
Laboratory of Movement Analysis, Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Gait Disorders, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 16 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 13 Mar 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantify of variability of the center-of-mass movement (time frame: 30 minutes). 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 NCT02134158, 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 13 Mar 2019.