<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04496609</url>
  </required_header>
  <id_info>
    <org_study_id>2016/50</org_study_id>
    <nct_id>NCT04496609</nct_id>
  </id_info>
  <brief_title>Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries</brief_title>
  <acronym>Parastim</acronym>
  <official_title>Assessment of the Efficacy and Safety of Epidural Electrical Stimulation of the Lumbosacral Spinal Cord in the Symptomatic Treatment of Motor, Vesico-sphincter and Genito-sexual Disorders in Patients With Incomplete Spinal Cord Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neurological disability caused by traumatic lesions of the spinal cord is a significant&#xD;
      challenge for medicine and society. These lesions, leading to sublesional central nervous&#xD;
      system dysfunction, include sensorimotor, vesico-sphincter and genito-sexual disorders. To&#xD;
      date, there is no treatment that enables spinal cord function to be restored.&#xD;
&#xD;
      Preclinical studies have been able to demonstrate the recovery of locomotor activity with a&#xD;
      combination of locomotor training, pharmacological intervention and epidural electrical&#xD;
      stimulation of the lumbosacral spinal cord (EESS) in adult rats with spinal cord transection.&#xD;
      An American team have recently been able to show that EESS, combined with locomotor training,&#xD;
      caused neurological improvement in four paraplegic patients, with electromyographic muscular&#xD;
      activation patterns similar to those observed during walking. In fact, these authors also&#xD;
      showed an improvement, under stimulation, of the VS and GS functions, but with no detailed&#xD;
      documentation.&#xD;
&#xD;
      Starting with a conceptual and preclinical rationale, and with proof of clinical concept&#xD;
      demonstrated in several reported cases, we propose a clinical trial with an original&#xD;
      cross-over design to validate the hypothesis that EESS combined with training in patients&#xD;
      with incomplete spinal cord injuries would, with a good tolerance profile, allow motor,&#xD;
      vesico-sphincter (VS) and genito-sexual (GS) disorders to be restored in patients with&#xD;
      incomplete spinal cord injuries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2021</start_date>
  <completion_date type="Anticipated">July 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of number of patients able to move over a distance of 5 metres</measure>
    <time_frame>through study completion</time_frame>
    <description>Determined by a capability to move over a distance of 5 metres with or without technical aid, with the option of stopping on the way</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients capable of moving at the end of treatment</measure>
    <time_frame>1 hour</time_frame>
    <description>Based on the rehabilitation programme over a distance of 5 metres with or without technical aid, with the option of stopping on the way, Surface EMG, Bipodal balance measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of vesico-sphincter function</measure>
    <time_frame>1 hour</time_frame>
    <description>Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the genito-sexual function</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the excitability of the spinal neuronal circuits</measure>
    <time_frame>1 hour</time_frame>
    <description>Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the kinetics of action of the induced effects</measure>
    <time_frame>1 hour</time_frame>
    <description>Assessment according to the epidural electrical stimulation paradigms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of capability to move over a distance of 5 metres at the end of washout period for treatment combining EESS and rehabilitation program</measure>
    <time_frame>throughout the study</time_frame>
    <description>Measurement of covered distance at the end of washout period for treatment combining EESS and rehabilitation program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of capability to move over a distance of 5 metres at the end of washout period for rehabilitation program</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measurement of covered distance at the end of washout period for rehabilitation program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of capability to move over a distance of 5 metres after 6 months of treatment</measure>
    <time_frame>Month 6</time_frame>
    <description>Measurement of covered distance after 6 months of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of vesico-sphincter function at the end of washout period for treatment combining EESS and rehabilitation program</measure>
    <time_frame>1 hour</time_frame>
    <description>Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of vesico-sphincter function at the end of washout period for rehabilitation program</measure>
    <time_frame>1 hour</time_frame>
    <description>Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of vesico-sphincter function after 6 months of treatment</measure>
    <time_frame>Month 6</time_frame>
    <description>Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the genito-sexual function at the end of washout period for treatment combining EESS and rehabilitation program</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the genito-sexual function at the end of washout period for rehabilitation program</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the genito-sexual function after 6 months of treatment</measure>
    <time_frame>Month 6</time_frame>
    <description>Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the excitability of the spinal neuronal circuits at the end of washout period for treatment combining EESS and rehabilitation program</measure>
    <time_frame>1 hour</time_frame>
    <description>Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the excitability of the spinal neuronal circuits at the end of washout period for rehabilitation program</measure>
    <time_frame>1 hour</time_frame>
    <description>Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the excitability of the spinal neuronal circuits after 6 months of treatment</measure>
    <time_frame>1 hour</time_frame>
    <description>Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of quality of life</measure>
    <time_frame>30 minutes</time_frame>
    <description>Measurement with EQ5D-3L (EuroQol 5 Dimensions - 3 Levels) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with AE/SAE related to tolerance</measure>
    <time_frame>through study completion</time_frame>
    <description>Reporting of AE and SAE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with AE/SAE related to safety</measure>
    <time_frame>through study completion</time_frame>
    <description>Reporting of AE and SAE</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Stimulation-automated rehabilitation/automated rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulation and automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days&#xD;
Washout 30 days&#xD;
Automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Automated rehabilitation/Stimulation-automated rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days&#xD;
Washout 30 days&#xD;
Stimulation and automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stimulation and automated rehabilitation / automated rehabilitation</intervention_name>
    <description>Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days</description>
    <arm_group_label>Stimulation-automated rehabilitation/automated rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated rehabilitation / Stimulation and automated rehabilitation</intervention_name>
    <description>Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days</description>
    <arm_group_label>Automated rehabilitation/Stimulation-automated rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 65 years inclusive&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Incomplete ASIA B or C spinal cord lesion with level of lesion located above T10&#xD;
             (sensation preserved below level of lesion)&#xD;
&#xD;
          -  Absence of significant motor deficit of the upper limbs or recovered motor deficit&#xD;
             (muscular score ≥ 4/5)&#xD;
&#xD;
          -  Patient with spinal cord injury at least 2 years old and considered stable not walking&#xD;
&#xD;
          -  Spinal cord lesion determined by spinal cord MRI (intramedullary hypersignal)&#xD;
&#xD;
          -  Patient who can benefit from an iterative rehabilitation programme&#xD;
&#xD;
          -  Patient with stable health condition with no cardiopulmonary disease&#xD;
&#xD;
          -  Patient with orthopaedic condition compatible with verticality and walking&#xD;
&#xD;
          -  Persistence of adductor reflexes up to L2&#xD;
&#xD;
          -  Patient with no current neuromodulation implant: spinal cord neurostimulator, brain,&#xD;
             peripheral nerve or intrathecal treatment&#xD;
&#xD;
          -  Patient with no coagulopathy, cardiac risk factors or other medical risk factors&#xD;
             significant for surgery&#xD;
&#xD;
          -  Local anatomical conditions compatible with implantation of the epidural electrode&#xD;
             (determined by MRI of the spinal cord)&#xD;
&#xD;
          -  Person who benefits from or is entitled to a social security scheme&#xD;
&#xD;
          -  Having provided signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cerebral lesion on a previous cerebral MRI&#xD;
&#xD;
          -  Psychiatric or cognitive disorder history (known or detected during the consultation&#xD;
             with the psychologist)&#xD;
&#xD;
          -  Protected adult patients&#xD;
&#xD;
          -  Pregnant (determined by a negative pregnancy test) or breastfeeding women&#xD;
&#xD;
          -  Respiratory failure (vital capacity &lt; 50%) (surgery in prone position)&#xD;
&#xD;
          -  Repeated urinary infections (≥3 per year)&#xD;
&#xD;
          -  Planned absence that may hinder participation in the study (travelling abroad,&#xD;
             relocation, imminent moving)&#xD;
&#xD;
          -  Patients with spasms (PENN scale &gt; 2)&#xD;
&#xD;
          -  Cauda equina syndrome&#xD;
&#xD;
          -  Patients presenting with a contraindication to an MRI being carried out: i) pacemaker,&#xD;
             ii) non-MRI-compatible heart valve, iii) clips, stents, coils, etc. that are not&#xD;
             MRI-compatible, iv) cochlear implant, v) metal foreign body, etc.)&#xD;
&#xD;
          -  Patients presenting with a contraindication to MEPs being carried out (notably wearing&#xD;
             of ferromagnetic material, heart stimulator)&#xD;
&#xD;
          -  Patients on oral anticoagulants&#xD;
&#xD;
          -  Patients with botulinic toxin injection&#xD;
&#xD;
          -  Patients with bedsore&#xD;
&#xD;
          -  Undernourished patients (BMI &lt; 19)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Béchir Jarraya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Foch</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elisabeth Hulier-Ammar</last_name>
    <phone>+33 1 46 25 11 75</phone>
    <email>drci-promotion@hopital-foch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hôpital Raymond Poincaré</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas Roche, MD</last_name>
      <phone>+33 1 47 10 79 00</phone>
      <email>nicolas.roche@aphp.fr</email>
    </contact>
    <investigator>
      <last_name>Nicolas Roche, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Béchir Jarraya, MD</last_name>
      <phone>+33 1 46 25 29 66</phone>
      <email>b.jarraya@hopital-foch.com</email>
    </contact>
    <investigator>
      <last_name>Béchir Jarraya, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04496609
org study id: 2016/50
nct id: NCT04496609
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neurological disability caused by traumatic lesions of the spinal cord is a significant
      challenge for medicine and society. These lesions, leading to sublesional central nervous
      system dysfunction, include sensorimotor, vesico-sphincter and genito-sexual disorders. To
      date, there is no treatment that enables spinal cord function to be restored.

      Preclinical studies have been able to demonstrate the recovery of locomotor activity with a
      combination of locomotor training, pharmacological intervention and epidural electrical
      stimulation of the lumbosacral spinal cord (EESS) in adult rats with spinal cord transection.
      An American team have recently been able to show that EESS, combined with locomotor training,
      caused neurological improvement in four paraplegic patients, with electromyographic muscular
      activation patterns similar to those observed during walking. In fact, these authors also
      showed an improvement, under stimulation, of the VS and GS functions, but with no detailed
      documentation.

      Starting with a conceptual and preclinical rationale, and with proof of clinical concept
      demonstrated in several reported cases, we propose a clinical trial with an original
      cross-over design to validate the hypothesis that EESS combined with training in patients
      with incomplete spinal cord injuries would, with a good tolerance profile, allow motor,
      vesico-sphincter (VS) and genito-sexual (GS) disorders to be restored in patients with
      incomplete spinal cord injuries.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of number of patients able to move over a distance of 5 metres
time frame: through study completion
description: Determined by a capability to move over a distance of 5 metres with or without technical aid, with the option of stopping on the way
measure: Percentage of patients capable of moving at the end of treatment
time frame: 1 hour
description: Based on the rehabilitation programme over a distance of 5 metres with or without technical aid, with the option of stopping on the way, Surface EMG, Bipodal balance measurement
measure: Assessment of vesico-sphincter function
time frame: 1 hour
description: Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
measure: Assessment of the genito-sexual function
time frame: 30 minutes
description: Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)
measure: Assessment of the excitability of the spinal neuronal circuits
time frame: 1 hour
description: Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation
measure: Assessment of the kinetics of action of the induced effects
time frame: 1 hour
description: Assessment according to the epidural electrical stimulation paradigms
measure: Assessment of capability to move over a distance of 5 metres at the end of washout period for treatment combining EESS and rehabilitation program
time frame: throughout the study
description: Measurement of covered distance at the end of washout period for treatment combining EESS and rehabilitation program
measure: Assessment of capability to move over a distance of 5 metres at the end of washout period for rehabilitation program
time frame: 30 minutes
description: Measurement of covered distance at the end of washout period for rehabilitation program
measure: Assessment of capability to move over a distance of 5 metres after 6 months of treatment
time frame: Month 6
description: Measurement of covered distance after 6 months of treatment
measure: Assessment of vesico-sphincter function at the end of washout period for treatment combining EESS and rehabilitation program
time frame: 1 hour
description: Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
measure: Assessment of vesico-sphincter function at the end of washout period for rehabilitation program
time frame: 1 hour
description: Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
measure: Assessment of vesico-sphincter function after 6 months of treatment
time frame: Month 6
description: Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
measure: Assessment of the genito-sexual function at the end of washout period for treatment combining EESS and rehabilitation program
time frame: 30 minutes
description: Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)
measure: Assessment of the genito-sexual function at the end of washout period for rehabilitation program
time frame: 30 minutes
description: Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)
measure: Assessment of the genito-sexual function after 6 months of treatment
time frame: Month 6
description: Measurement with MSHQ (Male Sexual Health Questionnaire) scale in men and FSFI (Female Sexual Function Index) in women MSHQ scale: minimum value (worse outcome): 7 - maximum value (better outcome): 80 FSFI scale: minimum value:2 (worse outcome) - maximum value: 36 (better outcome)
measure: Assessment of the excitability of the spinal neuronal circuits at the end of washout period for treatment combining EESS and rehabilitation program
time frame: 1 hour
description: Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation
measure: Assessment of the excitability of the spinal neuronal circuits at the end of washout period for rehabilitation program
time frame: 1 hour
description: Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation
measure: Assessment of the excitability of the spinal neuronal circuits after 6 months of treatment
time frame: 1 hour
description: Measurement of the reciprocal inhibition directed from the tibialis anterior to the soleus and the presynaptic inhibition applied to the fibres of the soleus by modifying the range of the soleus H-reflex obtained by percutaneous peripheral nerve electrical stimulation
measure: Assessment of quality of life
time frame: 30 minutes
description: Measurement with EQ5D-3L (EuroQol 5 Dimensions - 3 Levels) scale
measure: Number of patient with AE/SAE related to tolerance
time frame: through study completion
description: Reporting of AE and SAE
measure: Number of patient with AE/SAE related to safety
time frame: through study completion
description: Reporting of AE and SAE
arm group label: Stimulation-automated rehabilitation/automated rehabilitation
arm group type: Experimental
description: Stimulation and automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days
Washout 30 days
Automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days
arm group label: Automated rehabilitation/Stimulation-automated rehabilitation
arm group type: Experimental
description: Automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days
Washout 30 days
Stimulation and automated rehabilitation (2 sessions of 45 minutes per day) for 40 working days
intervention type: Device
intervention name: Stimulation and automated rehabilitation / automated rehabilitation
description: Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
arm group label: Stimulation-automated rehabilitation/automated rehabilitation
intervention type: Device
intervention name: Automated rehabilitation / Stimulation and automated rehabilitation
description: Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
arm group label: Automated rehabilitation/Stimulation-automated rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Béchir Jarraya, MD
role: Principal Investigator
affiliation: Hôpital Foch
last name: Elisabeth Hulier-Ammar
phone: +33 1 46 25 11 75
email: drci-promotion@hopital-foch.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries