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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation-automated rehabilitation/automated rehabilitation | Experimental |
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| Automated rehabilitation/Stimulation-automated rehabilitation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation and automated rehabilitation / automated rehabilitation | Device | Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | through study completion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 hour |
| Assessment of vesico-sphincter function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Béchir Jarraya, MD | Contact | 01 46 25 29 66 | b.jarraya@hopital-foch.com | |
| Marjolaine Ngollo, PhD | Contact | 01 46 25 37 49 | drci-promotion@hopital-foch.com |
| Name | Affiliation | Role |
|---|---|---|
| Béchir Jarraya, MD | Hôpital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Raymond Poincaré | Recruiting | Garches | 92380 | France |
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| Automated rehabilitation / Stimulation and automated rehabilitation | Device | Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days |
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Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan |
| 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) | 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 | 1 hour |
| Assessment of the kinetics of action of the induced effects | Assessment according to the epidural electrical stimulation paradigms | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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 | 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 | 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 | 1 hour |
| Assessment of quality of life | Measurement with EQ5D-3L (EuroQol 5 Dimensions - 3 Levels) scale | 30 minutes |
| Number of patient with AE/SAE related to tolerance | Reporting of AE and SAE | through study completion |
| Number of patient with AE/SAE related to safety | Reporting of AE and SAE | through study completion |
| Hôpital Foch | Recruiting | Suresnes | 92150 | France |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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