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Paired Associative Stimulation in Post-stroke Hand Motor Deficits (PAS-stroke)

This study is currently recruiting participants.
Verified August 2017 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284087
First Posted: November 5, 2014
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  Purpose

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)


Condition Intervention
Stroke and Healthy Subjects Device: PAS

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Paired Associative Stimulation Protocols Using Cerebellar or Visual Afferences in Post-stroke Hand Motor Deficits

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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 in corticospinal excitability by the motor evoked potentials [ Time Frame: Change from Baseline to day 5 (Pre and post intervention) ]

Estimated Enrollment: 60
Actual Study Start Date: September 17, 2014
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
V_PAS
Visuomotor paired associative stimulation protocol
Device: PAS
Sham V_PAS
Placebo group of Visuomotor paired associative stimulation protocol
CER_PAS
cerebellar-motor associative stimulation protocol
Device: PAS
Sham CER_PAS
Placebo group of cerebellar-motor associative stimulation protocol

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Stroke patients
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284087


Contacts
Contact: Charlotte ROSSO, PI 42161854 ext +331 charlotte.rosso@gmail.com
Contact: Sophie CORIOU, INSERM 42165778 ext +331 sophie.coriou@inserm.fr

Locations
France
ICM, CIC Neurosciences Recruiting
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Charlotte ROSSO, PI Brain and Spine institute, INSERM UMR 1127, CNRS 7225
  More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02284087     History of Changes
Other Study ID Numbers: C14-38
2014-A01165-42 ( Registry Identifier: IDBRCB )
First Submitted: October 21, 2014
First Posted: November 5, 2014
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
transcranial magnetic stimulation
movement disorders

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases