RECRUITING

Evaluating Spinal Cord Stimulation for Stiff Person Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Evaluating Spinal Cord Stimulation for Stiff Person Syndrome

Quick Facts

Study Start:2024-12

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06242678

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Janus S Patel, MD

CONTACT

336-716-8791

jspatel@wakehealth.edu

Enrique Galang, MD

CONTACT

336-716-8791

egalang@wakehealth.edu

Principal Investigator

Janus S Patel, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Janus S Patel, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2025-04

Study Record Updates

Study Start Date2024-12

Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

Stiff-Person Syndrome