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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
Hôpital Raymond Poincaré
Garches, France
RECRUITINGHôpital Foch
Suresnes, France
RECRUITINGAssessment 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
Time frame: through study completion
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
Time frame: 1 hour
Assessment of vesico-sphincter function
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Time frame: 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)
Time frame: 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
Time frame: 1 hour
Assessment of the kinetics of action of the induced effects
Assessment according to the epidural electrical stimulation paradigms
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
Measurement of covered distance 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
Measurement of covered distance 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
Measurement of covered distance 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
Measurement using cystomanometry, flow measurement and assessment of post-micturition residue by means of a bladder scan
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
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
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
Time frame: 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
Time frame: 1 hour
Assessment of quality of life
Measurement with EQ5D-3L (EuroQol 5 Dimensions - 3 Levels) scale
Time frame: 30 minutes
Number of patient with AE/SAE related to tolerance
Reporting of AE and SAE
Time frame: through study completion
Number of patient with AE/SAE related to safety
Reporting of AE and SAE
Time frame: through study completion
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