Evaluating Spinal Cord Stimulation for Stiff Person Syndrome
The purpose of this prospective pilot study is to gather preliminary evidence evaluating spinal cord stimulation (SCS) as a potential therapy for the treatment of rigidity and painful spasms in patients with stiff person syndrome (SPS), a rare autoimmune neurological condition. The hypothesis is that SCS-mediated clinical improvement occurs through multi-modal mechanisms of action targeting several components of neuronal inhibitory signaling pathways in the spinal cord.
• Is 18 years of age or older at the time that the Informed Consent Form (ICF) is signed.
• Has been clinically diagnosed with stiff person syndrome
• Has clinical symptoms of muscle rigidity and spasms in the truncal (including abdominal, thoracic paraspinal, and pectoral) or proximal lower limb musculature
• Has Cerebrospinal fluid (CSF) Anti-glutamic acid decarboxylase 65 (anti-GAD65) antibodies or serum anti-GAD65 antibodies present at any titer
• Is currently trying or has tried in the past at least two conventional therapies with insufficient symptomatic relief or intolerable side effects (such as nonsteroidal anti- inflammatory drugs, topical patches/creams/gels/ointments, physical therapy, acupuncture, bracing, assistive devices, and lifestyle modification).
• If taking oral medications, is willing to maintain a stable regimen for the duration of the study period.
• Is cleared for an implantable medical device by licensed mental health provider.
• Is an appropriate candidate for the surgical procedures required in this study based on clinical judgement of the study physician.
• Is willing to and capable of giving written informed consent.
• Is willing and able to comply with study-related requirements and procedures and attend scheduled visits.