NEUROMOdulation Pain Therapy in Combination With Intensive Physiotherapy

Condition(s) studied

Investigational drug(s) / intervention(s)

NEUROMOdulation pain therapy in combination with intensive physiotherapy: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Muscle strength at 2 weeks, 6 weeks, 6 and 12 months — 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).
  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).
• Change in Spasticity at 2 weeks, 6 weeks, 6 and 12 months — Post-assessment 1 (immediately after the end of two weeks hospitalisation)
  Hip flexors, knee flexors and extensors, dorsal and plantar flexors using the Modified Ashworth scale. The higher value, the worse function (higher spasticity).
• Change from Baseline Timed Up And Go at 2 weeks, 6 weeks, 6 and 12 months — Post-assessment 1 (immediately after the end of two weeks hospitalisation)
  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.
• Change from Baseline Berg Balance Scale at 2 weeks, 6 weeks, 6 and 12 months — Post-assessment 1 (immediately after the end of two weeks hospitalisation)
  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.
• Change from Baseline The 10 Metre Walk Test at 2 weeks, 6 weeks, 6 and 12 months — Post-assessment 1 (immediately after the end of two weeks hospitalisation)
  A performance measure used to assess walking speed in meters per second over 10 meters. Shorter times reflect better mobility.
• Change from Baseline The 6 Minute Walk Test at 2 weeks, 6 weeks, 6 and 12 months — Post-assessment 1 (immediately after the end of two weeks hospitalisation)
  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.
• Change in Walking Index for Spinal Cord Injury at 2 weeks, 6 weeks, 6 and 12 months — 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).
  questionnaire from 0 to 20. Higher number means better function.

Trial sites (1)

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