- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02284087
Paired Associative Stimulation in Post-stroke Hand Motor Deficits (PAS-stroke)
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)
Study Overview
Detailed Description
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 the investigators 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) Aim 7: for healthy subjects: determine the TMS parameters that will influence the response to cerebellar PAS protocols
Hypotheses
- The sensorimotor stimulation approach (V_PAS or CER_PAS) improves motor function of the hand compared to the control group. The CER_PAS approach may be more effective than V_PAS as the cerebellum plays a major role in the post-stroke recovery
- This improvement would be explained by an effect on brain reorganization by increasing the proportion of activation in the ipsilesional primary motor cortex comparing to the contralesional side, as well as strengthening the relationships between ipsilesional premotor and motor cortices.
- Clinical and electrophysiological effects observed in the combined approach are correlated with specific characteristics of the sensorimotor network assessed by MRI.
Perspectives Demonstrating beneficial effects would subsequently consider protocols in order to achieve a therapeutic effect in the long term. The low cost greatly facilitates the implementation of feasible treatments in routine care in specialized centers (or pilot research centers) and potentially useful in many patients. The study of the characteristics of responders and non-responders patients would provide "patient-oriented" treatment, which take into account the particularities of each subject.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Charlotte ROSSO, PI
- Phone Number: +331 42161854
- Email: charlotte.rosso@gmail.com
Study Contact Backup
- Name: Sophie CORIOU, INSERM
- Phone Number: +331 42165778
- Email: sophie.coriou@inserm.fr
Study Locations
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Paris, France, 75013
- Recruiting
- ICM, CIC Neurosciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
V_PAS
Visuomotor paired associative stimulation protocol
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|
Sham V_PAS
Placebo group of Visuomotor paired associative stimulation protocol
|
|
CER_PAS
cerebellar-motor associative stimulation protocol
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Sham CER_PAS
Placebo group of cerebellar-motor associative stimulation protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in lateralization indices in the primary motor cortex using functional magnetic Resonance
Time Frame: Change from Baseline to day 5 (Pre and post intervention)
|
Change from Baseline to day 5 (Pre and post intervention)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in motor score of the affected hand by the Jebsen Taylor Test
Time Frame: Change from Baseline to day 5 (Pre and post intervention)
|
Change from Baseline to day 5 (Pre and post intervention)
|
change in corticospinal excitability by the motor evoked potentials
Time Frame: Change from Baseline to day 5 (Pre and post intervention)
|
Change from Baseline to day 5 (Pre and post intervention)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Charlotte ROSSO, PI, Brain and Spine institute, INSERM UMR 1127, CNRS 7225
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- C14-38
- 2014-A01165-42 (Registry Identifier: IDBRCB)
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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