Spinal Cord Stimulation Surgery to Improve Lower Limb Motor Dysfunction in Adrenomyeloneuropathy (AMN): A Prospective, Multicenter, Single-Arm Study

What this Trial Is About

Adrenomyeloneuropathy (AMN) is a rare genetic disorder caused by mutations in the ABCD1 gene, leading to muscle weakness, reduced ankle joint movement, and nerve damage in the lower limbs. This condition causes a progression from increased muscle tone to paralysis, severely affecting walking and quality of life. Current treatments are limited, so researchers are exploring new options to improve symptoms and function in adults with AMN. This study evaluates spinal cord stimulation (SCS) as a potential treatment for lower limb muscle tone and movement problems in AMN patients. SCS involves implanting electrodes near the spinal cord and connecting them to a nerve stimulator that sends electrical pulses to stimulate nerves and improve motor function. After implantation, patients receive rehabilitation and use the stimulator regularly with specific schedules for continuous or intermittent stimulation. Participants will undergo preoperative evaluations followed by the implant surgery. They will then have scheduled assessments before and after starting stimulation at one week, four weeks, and follow-ups at four weeks and six months after hospital discharge. Researchers will measure walking ability, motor function, nerve signals, MRI scans, pain, and safety to understand the effects and risks of SCS in improving lower limb function in AMN patients over time.

Epidural Spinal Cord Stimulation for Lower-limb Impairment in Adrenomyeloneuropathy