Hemiparesis, Stroke, Traumatic Brain Injury
Conditions
Keywords
Neuroplasticity, Electrophysiology, MRI, Neurophysiology, Muscle vibration
Brief summary
Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. The aim of the research is to study the activity in cerebrospinal circuitry to evaluate the neuroplastic changes during and after instrumented proprioceptive rehabilitation relying on sequences of muscle vibration in subacute stroke stages.
Detailed description
Randomized control trial : 28 patients with active vibrations vs. 28 patients with sham stimulation Subacute phase : D15 to 6 months after stroke or patients with traumatic brain injury with similar semiology as stroke (hemiparesis) Measure at baseline : Electrophysiological investigations (EMG,EEG, MRI, clinical evaluation) Treatment of 5 weeks with 3 sessions of vibrations or sham a week Evaluation at mid time (electrophysiology and clinical examinations) Final examination (electrophysiology, MRI and clinical examination)
Interventions
DEVICEVibrations
Sequenced muscle vibrations during 30 min., 3 times a week during 5 weeks
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* hemiparesis at least transient in lower limb following an acquired brain injury (stroke or traumatic brain injury) * French spoken * Affiliated to a French social insurance * No previous traumatic, vascular or neurodegenerative injuries * Having presented during the acute phase or presenting a motor deficit of one of the lower limbs * Presenting an absence of autonomy of walking at the entrance of the rehabilitation department * In the sub-acute phase, i.e. from 15 days to 6 months after the accident * Presenting moderate cognitive disorders allowing them to understand instructions and give their consent
Exclusion criteria
* strong cognitive disorders * maintenance of justice, tutelage, legal guardianship * Pregnancy and breastfeeding * Outpatients who do not have weekly follow-up in the rehabilitation department
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline EMG | Evaluation at baseline (4 days before treatment) | H-reflex and reciprocal inhibition |
| Baseline EEG | Evaluation at baseline (4 days before treatment) | SEP and resting state activity |
| EMG change from baseline after 2-week treatment | Evaluation during the 3rd week of treatment | H-reflex and reciprocal inhibition |
| EEG change from baseline after 2-week treatment | Evaluation during the 3rd week of treatment | SEP and resting state activity |
| EMG change after the 5-week treatment | Evaluation 4 days after the end of the 5-week treatment | H-reflex and reciprocal inhibition |
| EEG change after the 5-week treatment | Evaluation 4 days after the end of the 5-week treatment | SEP and resting state activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline MD | Evaluation at baseline (4 days before treatment) | Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI |
| Baseline FA | Evaluation at baseline (4 days before treatment) | Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI |
| Baseline Muscle Strength | Evaluation at baseline (4 days before treatment) | score to Medical Research Council scale |
| Muscle Strength change from baseline after 2-week treatment | Evaluation during the 3rd week of treatment | score to Medical Research Council scale |
| Muscle Strength change from baseline after 5-week treatment | Evaluation 4 days after the end of the 5-week treatment | score to Medical Research Council scale |
| Baseline Spasticity | Evaluation at baseline (4 days before treatment) | score to Modified Ashworth scale |
| Spasticity change from baseline after 2-week treatment | Evaluation during the 3rd week of treatment | score to Modified Ashworth scale |
| Spasticity change from baseline after 5-week treatment | Evaluation 4 days after the end of the 5-week treatment | score to Modified Ashworth scale |
| Baseline sensorimotor function | Evaluation at baseline (4 days before treatment) | subscore for lower limbs to Fugl meyer assessment |
| Sensorimotor function change from baseline after 2-week treatment | Evaluation during the 3rd week of treatment | subscore for lower limbs to Fugl meyer assessment |
| Sensorimotor function change from baseline after 5-week treatment | Evaluation 4 days after the end of the 5-week treatment | subscore for lower limbs to Fugl meyer assessment |
| Baseline Balance | Evaluation at baseline (4 days before treatment) | Score to Berg balance scale |
| Balance change from baseline after 2-week treatment | Evaluation during the 3rd week of treatment | Score to Berg balance scale |
| Balance change from baseline after 5-week treatment | Evaluation 4 days after the end of the 5-week treatment | Score to Berg balance scale |
| Baseline walking | Evaluation at baseline (4 days before treatment) | score to 10-m walking test |
| Walking from baseline after 2-week treatment | Evaluation during the 3rd week of treatment | score to 10-m walking test |
| Walking from baseline after 5-week treatment | Evaluation 4 days after the end of the 5-week treatment | score to 10-m walking test |
| Change in MD | Evaluation 4 days after the end of the 5-week treatment | Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI |
| Change in FA | Evaluation 4 days after the end of the 5-week treatment | Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI |
Countries
France
Contacts
CONTACTVeronique Marchand-Pauvert, PhD
CONTACTEleonore Bayen, MD, PhD
PRINCIPAL_INVESTIGATOREleonore Bayen, MD, PhD
Sorbonne University - AP-HP (Pitié-Salpêtrière Hospital)
Outcome results
None listed