Spinal Cord InjuriesParastimNCT04496609
Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries
A study testing Stimulation and automated rehabilitation / automated rehabilitation and Automated rehabilitation / Stimulation and automated rehabilitation in people with Spinal Cord Injuries, run by Hopital Foch at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Stimulation and automated rehabilitation / automated rehabilitation and Automated rehabilitation / Stimulation and automated rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Jul 2021to 12 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Raymond Poincaré
Garches, 92380
Nicolas Roche, MD, +33 1 47 10 79 00, nicolas.roche@aphp.fr
Nicolas Roche, MD
- Recruiting
Hôpital Foch
Suresnes, 92150
Béchir Jarraya, MD, +33 1 46 25 29 66, b.jarraya@hopital-foch.com
Béchir Jarraya, MD
About this study
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
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Stimulation and automated rehabilitation / automated rehabilitation, Automated rehabilitation / Stimulation and automated rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation and automated rehabilitation / automated rehabilitationDevice
Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
Automated rehabilitation / Stimulation and automated rehabilitationDevice
Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
| Study group | Role | What they receive |
|---|---|---|
| Stimulation-automated rehabilitation/automated rehabilitation | Experimental | * 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 Receives: Device: Stimulation and automated rehabilitation / automated rehabilitation |
| Automated rehabilitation/Stimulation-automated rehabilitation | Experimental | * 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 Receives: Device: Automated rehabilitation / Stimulation and automated rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion
Secondary outcomes (20)
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
Measured: 1 hour
Assessment of vesico-sphincter function
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Measured: 1 hour
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)
Measured: 30 minutes
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
Measured: 1 hour
Assessment of the kinetics of action of the induced effects
Assessment according to the epidural electrical stimulation paradigms
Measured: 1 hour
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
Measured: throughout the study
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
Measured: 30 minutes
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
Measured: Month 6
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
Measured: 1 hour
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
Measured: 1 hour
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
Measured: Month 6
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)
Measured: 30 minutes
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)
Measured: 30 minutes
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)
Measured: Month 6
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
Measured: 1 hour
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
Measured: 1 hour
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
Measured: 1 hour
Assessment of quality of life
Measurement with EQ5D-3L (EuroQol 5 Dimensions - 3 Levels) scale
Measured: 30 minutes
Number of patient with AE/SAE related to tolerance
Reporting of AE and SAE
Measured: through study completion
Number of patient with AE/SAE related to safety
Reporting of AE and SAE
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start12 Jul 2021
- Primary completion12 Jul 2028 (estimated)
- Study completion12 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béchir Jarraya, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496609
- Sponsor's protocol ID
- 2016/50
- Acronym
- Parastim
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04496609
- Acronym / sponsor ID
- Parastim / 2016/50
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 12 Jul 2028 (estimated)
- Study completion
- 12 Jul 2029 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation-automated rehabilitation/automated rehabilitation | Experimental | Device: Stimulation and automated rehabilitation / automated rehabilitation* 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/Stimulation-automated rehabilitation | Experimental | Device: Automated rehabilitation / Stimulation and automated rehabilitation* 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation and automated rehabilitation / automated rehabilitationStimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days | Device | Stimulation-automated rehabilitation/automated rehabilitation |
| Automated rehabilitation / Stimulation and automated rehabilitationAutomated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days | Device | Automated rehabilitation/Stimulation-automated rehabilitation |
Primary outcome
Assessment of number of patients able to move over a distance of 5 metres
Time frame: through study completion
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
20 secondary outcomes
Percentage of patients capable of moving at the end of treatment
Time frame: 1 hour
Assessment of vesico-sphincter function
Time frame: 1 hour
Assessment of the genito-sexual function
Time frame: 30 minutes
Assessment of the excitability of the spinal neuronal circuits
Time frame: 1 hour
Assessment of the kinetics of action of the induced effects
Time frame: 1 hour
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
Assessment of capability to move over a distance of 5 metres at the end of washout period for rehabilitation program
Time frame: 30 minutes
Assessment of capability to move over a distance of 5 metres after 6 months of treatment
Time frame: Month 6
Assessment of vesico-sphincter function at the end of washout period for treatment combining EESS and rehabilitation program
Time frame: 1 hour
Assessment of vesico-sphincter function at the end of washout period for rehabilitation program
Time frame: 1 hour
Assessment of vesico-sphincter function after 6 months of treatment
Time frame: Month 6
Assessment of the genito-sexual function at the end of washout period for treatment combining EESS and rehabilitation program
Time frame: 30 minutes
Assessment of the genito-sexual function at the end of washout period for rehabilitation program
Time frame: 30 minutes
Assessment of the genito-sexual function after 6 months of treatment
Time frame: Month 6
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
Assessment of the excitability of the spinal neuronal circuits at the end of washout period for rehabilitation program
Time frame: 1 hour
Assessment of the excitability of the spinal neuronal circuits after 6 months of treatment
Time frame: 1 hour
Assessment of quality of life
Time frame: 30 minutes
Number of patient with AE/SAE related to tolerance
Time frame: through study completion
Number of patient with AE/SAE related to safety
Time frame: through study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Béchir Jarraya, MD principal investigator
Hôpital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation and automated rehabilitation / automated rehabilitation and Automated rehabilitation / Stimulation and automated rehabilitation in people with Spinal Cord Injuries, run by Hopital Foch at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Béchir Jarraya, MD (01 46 25 29 66, b.jarraya@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of number of patients able to move over a distance of 5 metres (time frame: through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.