Stroke and Healthy Subjects Clinical Trial
— PAS-strokeOfficial title:
Assessment of Paired Associative Stimulation Protocols Using Cerebellar or Visual Afferences in Post-stroke Hand Motor Deficits
Introduction The motor impairment of the upper extremity is the most common sequelae after
ischemic stroke. Transcranial magnetic stimulation (TMS) is a promising non- invasive
technique in the rehabilitation of motor deficits. However, its effect in post-stroke motor
deficits remains moderate our days. To potentiate the effect of TMS, techniques called Paired
Associative Stimulations (PAS) involving the integration of afferent sensory inputs at the
level of the ipsilesional primary motor cortex were developed in healthy subjects. PAS
techniques have shown a gain of corticospinal excitability by such phenomenon known as long
Term Potentiation (LTP) and a gain of motor performance. The investigators would like to
propose to evaluate two types of these techniques with a volley of visual afferents
(visuomotor stimulation, V_PAS) or of cerebellar afferents (CER_PAS), because these two
structures convey important information in the execution of the movement.
Design Multicenter, randomized, study, 60 patients in 3 parallel groups (V_PAS, CER_PAS,
control group with sham and sham V_PAS CER_PAS), 5 days of treatment, clinical assessment,
electrophysiological and MRI before, immediately post- and second post-assessments (4 weeks).
A group of 24 healthy subjects will undergo a parallel physiopathological study on the
underlying mechanisms of cerebellar PAS
Objectives Main objective: To determine whether (and how) Paired Associative Stimulation
technique (PAS) induces cerebral reorganization in the primary motor cortex compared to the
control group.
Aim 2: Determine whether (and which) type of PAS is capable of inducing changes in motor
performance of the upper limb paresis and duration Aim 3: Determine whether (and which) type
of PAS is capable of inducing changes in excitability of the corticospinal tract and duration
Aim 4: Determine how PAS techniques modify the functional connectivity during movement Aim 5:
Determine if connectivity changes during induced movement correlate with clinical
improvements Aim 6: Determine whether patients who benefit of a type of PAS have specific
anatomical lesion characteristics (volume, afferent and efferent white matter fasciculi
integrity)
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | March 2018 |
| Est. primary completion date | January 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria FOR PATIENTS: - First event ischemic stroke with hand motor deficit - Time since stroke > 30 days - Stroke lesion sparing the primary motor cortex (hand knob area) - Age between 18 and 85 ans Exclusion Criteria FOR PATIENTS: - No homonymous hemianopia - No contra-indications for TMS and MRI - Pregnancy - Epilepsia - Any pathology that threatened the 1 month follow up Inclusion Criteria FOR HEALTHY SUBJECTS: - Age between 18 and 85 - Right handed Exclusion Criteria FOR HEALTHY SUBJECTS - No contra-indications for TMS and MRI - Pregnancy - Any cerebral pathology or pathology that threatened the 1 month follow up |
| Country | Name | City | State |
|---|---|---|---|
| France | ICM, CIC Neurosciences | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in lateralization indices in the primary motor cortex using functional magnetic Resonance | Change from Baseline to day 5 (Pre and post intervention) | ||
| Secondary | change in motor score of the affected hand by the Jebsen Taylor Test | Change from Baseline to day 5 (Pre and post intervention) | ||
| Secondary | change in corticospinal excitability by the motor evoked potentials | Change from Baseline to day 5 (Pre and post intervention) |