Evaluating Spinal Cord Stimulation for Stiff Person Syndrome

Stiff-Person Syndrome Clinical Trial

Official title:

Evaluating Spinal Cord Stimulation for Stiff Person Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242678
• Other study ID #: IRB00098231
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: Janus S Patel, MD
• Phone: 336-716-4498
• Email: jspatel[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stiff-Person Syndrome
• Syndrome

Intervention

Device:
• SCS trial lead
placement of spinal cord stimulator trial leads to see if effective in the management of symptoms associated with stiff person syndrome

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	baseline pain will be measured on a 0-10 scale, with 10 being the worse level of pain, with improvement in pain level measured immediately prior to removal (kept in up to 10 days), with pain level reassessed at 14 days after trial leads removed to see if returned to baseline	Baseline
Primary	Pain Scores	baseline pain will be measured on a 0-10 scale, with 10 being the worse level of pain, with improvement in pain level measured immediately prior to removal (kept in up to 10 days), with pain level reassessed at 14 days after trial leads removed to see if returned to baseline	Day 24