Back to resultsAssessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries (Parastim)
Primary Purpose
Spinal Cord Injuries
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Stimulation and automated rehabilitation / automated rehabilitation
Automated rehabilitation / Stimulation and automated rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 and 65 years inclusive
- Male or female
- Incomplete ASIA B or C spinal cord lesion with level of lesion located above T10 (sensation preserved below level of lesion)
- Absence of significant motor deficit of the upper limbs or recovered motor deficit (muscular score ≥ 4/5)
- Patient with spinal cord injury at least 2 years old and considered stable not walking
- Spinal cord lesion determined by spinal cord MRI (intramedullary hypersignal)
- Patient who can benefit from an iterative rehabilitation programme
- Patient with stable health condition with no cardiopulmonary disease
- Patient with orthopaedic condition compatible with verticality and walking
- Persistence of adductor reflexes up to L2
- Patient with no current neuromodulation implant: spinal cord neurostimulator, brain, peripheral nerve or intrathecal treatment
- Patient with no coagulopathy, cardiac risk factors or other medical risk factors significant for surgery
- Local anatomical conditions compatible with implantation of the epidural electrode (determined by MRI of the spinal cord)
- Person who benefits from or is entitled to a social security scheme
- Having provided signed informed consent
Exclusion Criteria:
- Significant cerebral lesion on a previous cerebral MRI
- Psychiatric or cognitive disorder history (known or detected during the consultation with the psychologist)
- Protected adult patients
- Pregnant (determined by a negative pregnancy test) or breastfeeding women
- Respiratory failure (vital capacity < 50%) (surgery in prone position)
- Repeated urinary infections (≥3 per year)
- Planned absence that may hinder participation in the study (travelling abroad, relocation, imminent moving)
- Patients with spasms (PENN scale > 2)
- Cauda equina syndrome
- Patients presenting with a contraindication to an MRI being carried out: i) pacemaker, ii) non-MRI-compatible heart valve, iii) clips, stents, coils, etc. that are not MRI-compatible, iv) cochlear implant, v) metal foreign body, etc.)
- Patients presenting with a contraindication to MEPs being carried out (notably wearing of ferromagnetic material, heart stimulator)
- Patients on oral anticoagulants
- Patients with botulinic toxin injection
- Patients with bedsore
- Undernourished patients (BMI < 19)
Sites / Locations
- Hôpital Raymond PoincaréRecruiting
- Hôpital FochRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stimulation-automated rehabilitation/automated rehabilitation
Automated rehabilitation/Stimulation-automated rehabilitation
Arm 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
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
Outcomes
Primary Outcome Measures
Assessment of number of patients able to move over a distance of 5 metres
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
Secondary Outcome Measures
Percentage of patients capable of moving at the end of treatment
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
Assessment of vesico-sphincter function
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Assessment of the genito-sexual function
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)
Assessment of the excitability of the spinal neuronal circuits
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
Assessment of the kinetics of action of the induced effects
Assessment according to the epidural electrical stimulation paradigms
Assessment of capability to move over a distance of 5 metres at the end of washout period for treatment combining EESS and rehabilitation program
Measurement of covered distance at the end of washout period for treatment combining EESS and rehabilitation program
Assessment of capability to move over a distance of 5 metres at the end of washout period for rehabilitation program
Measurement of covered distance at the end of washout period for rehabilitation program
Assessment of capability to move over a distance of 5 metres after 6 months of treatment
Measurement of covered distance after 6 months of treatment
Assessment of vesico-sphincter function at the end of washout period for treatment combining EESS and rehabilitation program
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Assessment of vesico-sphincter function at the end of washout period for rehabilitation program
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Assessment of vesico-sphincter function after 6 months of treatment
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Assessment of the genito-sexual function at the end of washout period for treatment combining EESS and rehabilitation program
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)
Assessment of the genito-sexual function at the end of washout period for rehabilitation program
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)
Assessment of the genito-sexual function after 6 months of treatment
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)
Assessment of the excitability of the spinal neuronal circuits at the end of washout period for treatment combining EESS and rehabilitation program
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
Assessment of the excitability of the spinal neuronal circuits at the end of washout period for rehabilitation program
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
Assessment of the excitability of the spinal neuronal circuits after 6 months of treatment
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
Assessment of quality of life
Measurement with EQ5D-3L (EuroQol 5 Dimensions - 3 Levels) scale
Number of patient with AE/SAE related to tolerance
Reporting of AE and SAE
Number of patient with AE/SAE related to safety
Reporting of AE and SAE
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04496609
Brief Title
Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries
Acronym
Parastim
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
July 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stimulation-automated rehabilitation/automated rehabilitation
Arm Type
Experimental
Arm 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 Title
Automated rehabilitation/Stimulation-automated rehabilitation
Arm Type
Experimental
Arm 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(s)
Stimulation and automated rehabilitation / automated rehabilitation
Intervention Description
Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
Intervention Type
Device
Intervention Name(s)
Automated rehabilitation / Stimulation and automated rehabilitation
Intervention Description
Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
Primary Outcome Measure Information:
Title
Assessment of number of patients able to move over a distance of 5 metres
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
Time Frame
through study completion
Secondary Outcome Measure Information:
Title
Percentage of patients capable of moving at the end of treatment
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
Time Frame
1 hour
Title
Assessment of vesico-sphincter function
Description
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Time Frame
1 hour
Title
Assessment of the genito-sexual function
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)
Time Frame
30 minutes
Title
Assessment of the excitability of the spinal neuronal circuits
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
Time Frame
1 hour
Title
Assessment of the kinetics of action of the induced effects
Description
Assessment according to the epidural electrical stimulation paradigms
Time Frame
1 hour
Title
Assessment of capability to move over a distance of 5 metres at the end of washout period for treatment combining EESS and rehabilitation program
Description
Measurement of covered distance at the end of washout period for treatment combining EESS and rehabilitation program
Time Frame
throughout the study
Title
Assessment of capability to move over a distance of 5 metres at the end of washout period for rehabilitation program
Description
Measurement of covered distance at the end of washout period for rehabilitation program
Time Frame
30 minutes
Title
Assessment of capability to move over a distance of 5 metres after 6 months of treatment
Description
Measurement of covered distance after 6 months of treatment
Time Frame
Month 6
Title
Assessment of vesico-sphincter function at the end of washout period for treatment combining EESS and rehabilitation program
Description
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Time Frame
1 hour
Title
Assessment of vesico-sphincter function at the end of washout period for rehabilitation program
Description
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Time Frame
1 hour
Title
Assessment of vesico-sphincter function after 6 months of treatment
Description
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Time Frame
Month 6
Title
Assessment of the genito-sexual function at the end of washout period for treatment combining EESS and rehabilitation program
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)
Time Frame
30 minutes
Title
Assessment of the genito-sexual function at the end of washout period for rehabilitation program
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)
Time Frame
30 minutes
Title
Assessment of the genito-sexual function after 6 months of treatment
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)
Time Frame
Month 6
Title
Assessment of the excitability of the spinal neuronal circuits at the end of washout period for treatment combining EESS and rehabilitation program
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
Time Frame
1 hour
Title
Assessment of the excitability of the spinal neuronal circuits at the end of washout period for rehabilitation program
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
Time Frame
1 hour
Title
Assessment of the excitability of the spinal neuronal circuits after 6 months of treatment
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
Time Frame
1 hour
Title
Assessment of quality of life
Description
Measurement with EQ5D-3L (EuroQol 5 Dimensions - 3 Levels) scale
Time Frame
30 minutes
Title
Number of patient with AE/SAE related to tolerance
Description
Reporting of AE and SAE
Time Frame
through study completion
Title
Number of patient with AE/SAE related to safety
Description
Reporting of AE and SAE
Time Frame
through study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 18 and 65 years inclusive
Male or female
Incomplete ASIA B or C spinal cord lesion with level of lesion located above T10 (sensation preserved below level of lesion)
Absence of significant motor deficit of the upper limbs or recovered motor deficit (muscular score ≥ 4/5)
Patient with spinal cord injury at least 2 years old and considered stable not walking
Spinal cord lesion determined by spinal cord MRI (intramedullary hypersignal)
Patient who can benefit from an iterative rehabilitation programme
Patient with stable health condition with no cardiopulmonary disease
Patient with orthopaedic condition compatible with verticality and walking
Persistence of adductor reflexes up to L2
Patient with no current neuromodulation implant: spinal cord neurostimulator, brain, peripheral nerve or intrathecal treatment
Patient with no coagulopathy, cardiac risk factors or other medical risk factors significant for surgery
Local anatomical conditions compatible with implantation of the epidural electrode (determined by MRI of the spinal cord)
Person who benefits from or is entitled to a social security scheme
Having provided signed informed consent
Exclusion Criteria:
Significant cerebral lesion on a previous cerebral MRI
Psychiatric or cognitive disorder history (known or detected during the consultation with the psychologist)
Protected adult patients
Pregnant (determined by a negative pregnancy test) or breastfeeding women
Respiratory failure (vital capacity < 50%) (surgery in prone position)
Repeated urinary infections (≥3 per year)
Planned absence that may hinder participation in the study (travelling abroad, relocation, imminent moving)
Patients with spasms (PENN scale > 2)
Cauda equina syndrome
Patients presenting with a contraindication to an MRI being carried out: i) pacemaker, ii) non-MRI-compatible heart valve, iii) clips, stents, coils, etc. that are not MRI-compatible, iv) cochlear implant, v) metal foreign body, etc.)
Patients presenting with a contraindication to MEPs being carried out (notably wearing of ferromagnetic material, heart stimulator)
Patients on oral anticoagulants
Patients with botulinic toxin injection
Patients with bedsore
Undernourished patients (BMI < 19)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hulier-Ammar
Phone
+33 1 46 25 11 75
Email
drci-promotion@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béchir Jarraya, MD
Organizational Affiliation
Hôpital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Raymond Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Roche, MD
Phone
+33 1 47 10 79 00
Email
nicolas.roche@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nicolas Roche, MD
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Béchir Jarraya, MD
Phone
+33 1 46 25 29 66
Email
b.jarraya@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
Béchir Jarraya, MD
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries
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