- Trial Name
- SCS SMA (device)
- Age:
- 16 to 64 years old.
- Aims:
- To verify that spinal cord stimulation increases hip muscle strength in subjects with SMA.
- To verify that spinal cord stimulation improves motor control in subjects with SMA.
- To verify that spinal cord stimulation induces measurable changes in spinal circuits and motoneuron recruitment properties in the 29 day course of implantation.
- Status:
- Active, not recruiting
- Location:
- USA
- Identifier:
- NCT05430113
Clinical Trials
Overview
Device: Spinal Cord Stimulator (octopolar Medtronic Vectris Leads) - SCS
A spinal cord stimulator (octopolar Medtronic Vectris Lads) is being piloted to see if it can improve motor deficits in people with type 3 or 4 SMA.
The investigators will enrol up to six subjects with Type 3 or 4 SMA, aged 16 or older, that show quantifiable motor deficits of the legs but are able to stand independently.
The investigators will implant the subjects with percutaneous, bilateral, linear spinal leads in the epidural space (T12-L2 vertebra), for a period of up to 29 days. The leads will be connected to external stimulators (either FDA-approved or human-grade research stimulator with safety features) during research activities.
Although these leads are not optimised for motor function, but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted.
Method of Action
SCS will boost remaining or restored (by treatment), motor neurons.