Clinical trial NCT06242678: Evaluating Spinal Cord Stimulation for Stiff Person Syndrome
Official title: Evaluating Spinal Cord Stimulation for Stiff Person Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stiff-Person Syndrome
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Primary outcomes:
measure: Pain Scores
timeFrame: Baseline
measure: Pain Scores
timeFrame: Day 24
measure: Michigan Body map
timeFrame: baseline
measure: Michigan Body Map
timeFrame: up to day 10
measure: Penn Spasm Frequency and Severity Scale
timeFrame: Baseline
measure: Penn Spasm Frequency and Severity Scale
timeFrame: up to day 10
measure: Pain Disability Index
timeFrame: Baseline
measure: Pain Disability Index
timeFrame: up to Day 10
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: up to Day 10
measure: Fatigue Severity Scale (FSS) scores
timeFrame: baseline
measure: Fatigue Severity Scale (FSS) scores
timeFrame: up to day 10
measure: Patient Health Questionnaire-Depression
timeFrame: baseline
measure: Patient Health Questionnaire-Depression
timeFrame: up to day 10
measure: Generalized Anxiety Disorder
timeFrame: baseline
measure: Generalized Anxiety Disorder
timeFrame: up to day 10
measure: EuroQOL (EQ-5D-5L)
timeFrame: Baseline
measure: EuroQOL (EQ-5D-5L)
timeFrame: up to Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Janus S Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: