Health TrialsbyHealthPanel

Assessment of the Efficacy and Safety of EESS in Patients With Incomplete Spinal Cord Injuries

ConditionSpinal Cord Injuries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHopital Foch

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

  • 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

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Stimulation-automated rehabilitation/automated rehabilitationExperimental treatment 1 intervention
Group B: Automated rehabilitation/Stimulation-automated rehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
through study completion

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hopital Foch

Lead sponsor

Source ClinicalTrials.gov
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