- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134158
Impact of tDCS on Locomotion and Equilibrium in Hemiplegic Patients (HEMILOCOSTICOR)
Impact of Transcranial Direct Current Stimulation (tDCS) on Locomotion and Bipedal Equilibrium in Hemiplegic Patients: a Crossover Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Hauts-de-Seine
-
Garches, Hauts-de-Seine, France, 92380
- Raymond Poincaré Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults
- Unilateral stroke
- More than 6 months after stroke
- Ability to walk during 10 minutes without stopping
- Informed consent signed
Exclusion Criteria :
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sham and then anodal
visit 2 sham stimulation (120 seconds) and visit 3 anodal stimulation (30 minutes)
|
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. |
Experimental: anodal and then sham
visit 2 anodal stimulation (30 minutes) and visit 3 sham stimulation (120 seconds)
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symmetry index calculating
Time Frame: 30 Minutes
|
Symmetry index of the spatio-temporal parameters of gait Calculating methods of the symmetry: using the robinson index
|
30 Minutes
|
Continuous relative phase
Time Frame: 30 Minutes
|
Assessment of the inter-segment coordination of the thigh-leg and leg-foot using the continuous relative phase.
|
30 Minutes
|
Functional data
Time Frame: 30 minutes
|
Time of climbing and descending 10 stairs of 11 cm Timed Up and Go test Box and Block Test
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicolas ROCHE, MD, PhD, Laboratory of Movement Analysis, Raymond Poincaré Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P120135 / AOM12126
- 2013-A00952-43 (Other Identifier: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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