paraplegia Spinal Cord Injury (SCI)
Conditions
Interventions
The invasive interventions in the study consist of:
1) Surgical placement of max. 8 DRG-leads (under local anesthesia) for a trial
phase (2 weeks)
2) After 2 weeks of trial phase: surgical removal of
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Paraplegia caused by trauma, post-surgical neurological deficits or pathological spinal compression > than one year prior to inclusion - Grade A-D neurological deficit on the American Spinal Injury Association Impairment Scale (AIS) (see research protocol chapter 4) - Age >=18 years - Patient-reported and clinically confirmed refractory spasticity
Exclusion criteria
Exclusion criteria: - Level >=3 on the American Society of Anesthesiologists (ASA) Classification - Implantation with non-MRI compatible devices/materials - Polyneuropathy (PNP) or peripheral motor neuron disease as assessed during screening measurement - Complete absence of H-reflexes as assessed during screening measurement - Lumbar MRI shows
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is (a change in) spasticity (frequency and/or intensity) in patients with motor complete and incomplete SCI who have been implanted with a permanent DRG stimulator for one year. At ten points over this year, clinical changes will be recorded and analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters include (any changes in) postural stability as well as patient-reported differences in secondary health outcomes (functional independence, pain, bladder and bowel function, sexual function, and quality of life). The safety of chronic DRG stimulation will be monitored throughout the study. | — |
Countries
Netherlands
Outcome results
None listed