evaluating spinal cord stimulation for stiff person syndrome

Conditions: Stiff-Person Syndrome

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * is less than 18 years of age at the time at the time that the informed consent form (icf) is signed. * has a body mass index (bmi) \> 45. * has a history of spine surgery or is planning to receive a spinal injection or procedure while participating in the study, unless this procedure can be postponed until after study completion. * has radiological findings or evidence of moderate to severe central spinal canal stenosis or neuroforaminal stenosis at any thoracic level or laterality. * has radiological findings or evidence of moderate/severe central spinal canal stenosis at any cervical or lumbar level. * has had an epidural steroid injection within 6 weeks of enrollment. * has a history of infection of the spine within 6 months of enrollment. * has received intravenous immunoglobulin therapy within 30 days or is unwilling to maintain a stable regimen (no change in dosage or frequency) during the study period. * has a history of opioid misuse or current chronic opioid therapy. * has evidence of a coagulation abnormality or low platelet count (\<120,000) indicated on complete blood count test at screening, or has a history of abnormal bleeding, or if unable to pause anticoagulation therapy in accordance with accepted guidelines for a spinal cord stimulator trial. * has a current local infection at the anticipated surgical entry site, active systemic infection, or active malignancy. * has a medical condition or pain in other area(s) not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as radicular pain, post-herpetic neuralgia, central canal stenosis of the cervical, thoracic or lumbar spine, critical limb ischemia due to peripheral vascular disease, or small vessel disease). * has a history of untreated major depressive disorder, or history of any mental health disorder with psychotic features, such as schizophrenia. * is pregnant (confirmed via pregnancy test) or plans on becoming pregnant during the study period. * has had, within six months of enrollment, a significant untreated addiction to dependency producing medications, alcohol or illicit drugs. * is concomitantly participating in another interventional clinical trial. * is involved in an injury claim for a study-related chronic pain that is under current litigation. * is a recipient of temporary social security disability insurance (ssdi) benefits due to study related chronic pain. * has a pending or approved worker's compensation claim for study-related chronic pain. * has low english language literacy interfering with the ability to complete study requirements.