NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy

Study Overview
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Brief Summary
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In this project, the aim is to verify that neuromodulation therapy (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs.

Detailed Description
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So far, posterior spinal cord neurostimulation (NM SCS) has been applied as a standard in patients with the most severe forms of pharmacoresistant neuropathic pain. The most recent research of the last 1-2 years brings clinical findings that, in a mode and modified arrangement, it could even induce rhythmic muscle activity of the lower limbs and help in verticalization and assisted bipedal locomotion. In this project, the aim is to verify that neuromodulation therapy SCS (spinal cord stimulation) in combination with intensive physiotherapy on a neurophysiological basis will lead to the restoration of mobility of lower limbs. In the therapy, the neuronal circuits of the lumbosacral region, where the so-called central pattern generators for locomotion are located will be targeted. Neurostimulation of this area will generate motor movement patterns corresponding to the previous mapping of the corresponding muscle groups. These will be supported by intensive physiotherapy on a neurophysiological basis - thanks to it and the facilitation of movement by neurostimulation, global motor patterns will be triggered, and motor programs stored at the subcortical level will be activated. Their memorization and subsequent spontaneous retrieval will facilitate sensorimotor learning techniques. Current research further shows that neurostimulation stimulates neurons in Rexed laminae 3-5, specifically a group of neurons designated as SC VSX2 and subsequently proprioceptive fibres. Physiotherapy will enhance the effect of neuromodulation by stimulating proprioceptors using soft and neurophysiologically based techniques. Proprioceptive fibres make connections to motoneurons and also ascend through the spinal cord to the brain, and thus reflex motor movements can be triggered. Information about them is carried to the brain by ascending pathways, and thus a free awareness of the movement facilitated by the neurostimulator occurs. All these mechanisms should potentiate plasticity (and lead to the restoration of locomotion.

Official Title
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NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy on a Neurophysiological Basis Improves Not Only Pain But Also Mobility in Spastic Paraparesis

Conditions
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Spinal Cord

Intervention / Treatment
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* Procedure: NEUROMOdulation pain therapy in combination with intensive physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: spinal cord lesion Exclusion Criteria: other neurological conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEUROMOdulation pain therapy in combination with intensive physiotherapy<br>Neuromodulation therapy (low-voltage electrical stimulation of the posterior roots of the spinal cord) by electrodes inserted epidurally from a laminotomy in the lumbosacral region. Intensive, four hour per day, individual physiotherapy (soft techniques, methods based on neurophysiology, so-called neuroproprioceptive facilitation, inhibition (Vojta's reflex method, Motor programs activating therapy, Proprioceptive neuromuscular stimulation, Bobath concept) will be combined with methods of acquiring motor skills (individualized therapy using the knowledge of sensorimotor learning) will take minimally one month. | Procedure: NEUROMOdulation pain therapy in combination with intensive physiotherapy<br>* Neuromodulation: Spinal cord stimulation affects nerve tissues with a defined electrical current. We will use low-voltage electrical stimulation of the posterior roots of the spinal cord in the MRI region of the localized conus medullaris. Electrodes are inserted epidurally from a laminotomy in the lumbosacral region. Physiotherapy will be based on recommendations for spinal patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle strength at 2 weeks, 6 weeks, 6 and 12 months | Hip flexion, abduction and extension, knee flexion and extension, plantar flexion and dorsiflexion using a microFET2 digital dynamometer. The higher value, the better function (higher strength). | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change in Spasticity at 2 weeks, 6 weeks, 6 and 12 months | Hip flexors, knee flexors and extensors, dorsal and plantar flexors using the Modified Ashworth scale. The higher value, the worse function (higher spasticity). | Post-assessment 1 (immediately after the end of two weeks hospitalisation) | 
| Change from Baseline Timed Up And Go at 2 weeks, 6 weeks, 6 and 12 months | The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility. | Post-assessment 1 (immediately after the end of two weeks hospitalisation) | 
| Change from Baseline Berg Balance Scale at 2 weeks, 6 weeks, 6 and 12 months | The subject stands up from a chair, walks 3m, turns back, and sits down again as quickly and safely as possible while being timed. Higher times reflect worse mobility. | Post-assessment 1 (immediately after the end of two weeks hospitalisation) | 
| Change from Baseline The 10 Metre Walk Test at 2 weeks, 6 weeks, 6 and 12 months | A performance measure used to assess walking speed in meters per second over 10 meters. Shorter times reflect better mobility. | Post-assessment 1 (immediately after the end of two weeks hospitalisation) | 
| Change from Baseline The 6 Minute Walk Test at 2 weeks, 6 weeks, 6 and 12 months | A long walking capacity test recording the maximal distance a subject walks at the fastest speed possible in 6 minutes. The more distance covered, the better the walking performance is. | Post-assessment 1 (immediately after the end of two weeks hospitalisation) | 
| Change in Walking Index for Spinal Cord Injury at 2 weeks, 6 weeks, 6 and 12 months | questionnaire from 0 to 20. Higher number means better function. | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Scale for pain at 2 weeks, 6 weeks, 6 and 12 months | scale from 0 to 10. Higher number means worse function (higher subjective feeling of pain) | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change in The Fatigue Scale for Motor and Cognitive Functions at 2 weeks, 6 weeks, 6 and 12 months | Questionnaire with 20 questions on fatigue. Higher number, worse fatigue. | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change in SYMBOL DIGIT MODALITIES TEST at 2 weeks, 6 weeks, 6 and 12 months | Cognitive testing (putting right symbols in 90 seconds). Higher number, better function. | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change in European Health Questionnaire at 2 weeks, 6 weeks, 6 and 12 months | questionnaire on Quality of Life. Higher value, better quality of life. | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change from Baseline World Health Organisation Disability Assessment Schedule 2.0 at 2 weeks, 6 weeks, 6 and 12 months | the 36-item questionnaire, higher score means higher disability | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change in the 36-Item Short Form Survey Instrument at 2 weeks, 6 weeks, 6 and 12 months | 36 item questionnaire. Higher number, worse quality of life. | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change from Baseline Goal Attainment scale at 2 weeks, 6 weeks, 6 and 12 months | Each goal is rated on 5-point scale (-2 much less than expected, 0 achieved the expected level, 2 much more than expected). Higher score means a better outcome. | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 
| Change in the Spinal Cord Independence Measure at 2 weeks, 6 weeks, 6 and 12 months | 17 item questionnaire. Higher number, better function (lower independence). | Pre-assessment (baseline testing), Post-assessment 1 (immediately after the end of two weeks hospitalisation), Post-assessment 2 (immediately after the end of one month hospitalisation), Follow up (6 and 12 month after beginning of the study). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord stimulation, physiotherapy