Spinal Cord Stimulation for Stiff Person Syndrome

Overseen By Janus S Patel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Spine surgery, Severe stenosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests spinal cord stimulation (SCS) as a potential treatment for individuals with stiff person syndrome (SPS), a rare disorder causing severe muscle stiffness and painful spasms. Researchers aim to determine if SCS can reduce these symptoms by affecting nerve signals in the spinal cord. The trial seeks participants diagnosed with SPS who experience muscle stiffness and spasms and have not found relief from at least two other treatments. As an unphased trial, this study provides a unique opportunity for patients to contribute to groundbreaking research that could lead to new treatment options for SPS.

Will I have to stop taking my current medications?

The trial requires that if you are taking oral medications, you must maintain a stable regimen (no changes in dosage or frequency) for the duration of the study.

What prior data suggests that spinal cord stimulation is safe for treating stiff person syndrome?

Research has shown that spinal cord stimulation (SCS) has been considered for treating various conditions, including stiff person syndrome (SPS). In earlier studies, patients using SCS for SPS experienced improvements in symptoms and daily activities. This suggests that SCS might help reduce stiffness and painful muscle spasms, common in SPS.

Safety information from other studies on SCS has focused on tracking side effects. Participants rated discomfort or pain on a simple scale, helping researchers assess treatment safety. Additionally, when used for other conditions, SCS has been found safe and practical, with no serious side effects reported.

While promising evidence supports the safety and effectiveness of SCS, this specific trial is a prospective pilot study. It aims to gather initial evidence, so the safety information is not as detailed as in larger studies. However, existing research provides a reassuring basis for considering SCS as a treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Spinal Cord Stimulation (SCS) for Stiff Person Syndrome is unique because it offers a novel approach to managing this condition by targeting nerve pathways directly. Unlike traditional treatments such as benzodiazepines and muscle relaxants that focus on symptom relief, SCS works by delivering electrical impulses to the spinal cord to modulate nerve activity and potentially reduce muscle stiffness and spasms. Researchers are excited about SCS because it could provide a more targeted, potentially effective, and long-lasting solution, addressing the underlying neurological disruptions rather than just alleviating symptoms.

What evidence suggests that spinal cord stimulation is effective for stiff person syndrome?

Research shows that spinal cord stimulation (SCS), which participants in this trial will receive, can help manage pain and muscle problems. For individuals with stiff person syndrome (SPS), a condition causing muscle stiffness and spasms, SCS has improved function and relieved symptoms. Studies indicate that SCS provides significant pain relief for more than half of the patients over time. Although still early, these findings suggest that SCS might reduce stiffness and painful spasms in SPS by influencing nerve pathways in the spinal cord. ^{5 6 7 8 9}

Who Is on the Research Team?

Janus S Patel, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with stiff person syndrome (SPS) who have tried at least two conventional therapies without enough relief or experienced intolerable side effects. Participants must have anti-GAD65 antibodies, maintain a stable oral medication regimen during the study, and be cleared for an implantable device. Exclusions include recent immunoglobulin therapy, bleeding disorders, opioid misuse, active infections or malignancy, certain mental health conditions, pregnancy, litigation related to chronic pain claims.

Inclusion Criteria

I am willing and able to sign a consent form.

Is cleared for an implantable medical device by licensed mental health provider

I have been diagnosed with stiff person syndrome.

Exclusion Criteria

I have a blood clotting issue or low platelets, or I can't stop my blood thinner for a test.

Has had, within six months of enrollment, a significant untreated addiction to dependency producing medications, alcohol or illicit drugs

Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study related chronic pain

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of spinal cord stimulator trial leads and evaluation of its effects on rigidity and painful spasms

10 days

1 visit (in-person) for lead placement, multiple assessments up to day 10

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain level reassessment at 14 days after trial leads removed

14 days

1 visit (in-person) for follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulation

Trial Overview The trial is testing spinal cord stimulation (SCS) as a treatment for rigidity and spasms in SPS patients. It's a prospective pilot study designed to see if SCS can improve symptoms by affecting neuronal inhibitory signaling pathways in the spinal cord.

How Is the Trial Designed?

Group I: SCS trial lead Experimental Treatment 1 Intervention

placement of spinal cord stimulator trial leads

Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)
• Phantom limb/stump pain
• Ischemic pain of vascular origin
• Complex regional pain syndrome
• Pain after an amputation
• Visceral abdominal pain and perineal pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Spinal cord injury pain
• Failed back surgery syndrome (FBSS)
• Adhesive arachnoiditis
• Peripheral causalgia/neuropathy
• Reflex sympathetic dystrophy (RSD)

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

Electrical spinal cord stimulation (ESCS) provides significant and sustained pain relief for patients with chronic painful diabetic neuropathy, with median pain scores showing a marked reduction when the stimulator is on compared to when it is off.

The procedure has a low complication rate, with only two late complications reported among the patients, indicating that ESCS is a safe long-term treatment option for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Daousi, C., Benbow, SJ., MacFarlane, IA.[2019]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

Epidural spinal electrostimulation (ESES) has shown promising results in improving spinal spasticity and mobility by 20 to 30% in patients with multiple sclerosis and myelopathy, indicating its efficacy in treating severe central motor disturbances.

In addition to mobility improvements, ESES led to a complete disappearance of spastic cramps in all treated cases and significant pain relief in three patients with chronic pain, suggesting its potential as a non-surgical intervention for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Epidural spinal electrostimulation (ESES) in patients with chronic pain and central motor disturbances (author's transl)]. Klingler, D., Kepplinger, B., Gerstenbrand, F., et al.[2006]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

In a study involving 15 healthy participants, transcutaneous electrical spinal cord stimulation (tSCS) significantly increased quadriceps motor evoked potentials (Q-MEP) during active stimulation compared to baseline and sham stimulation, indicating its potential for enhancing motor function.

The study found no significant changes in tibialis anterior motor evoked potentials (TA-MEP) or isometric strength, suggesting that tSCS specifically targets certain muscle responses, potentially reflecting its mechanism of action at the interneuronal or motoneuronal level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation Enhances Quadriceps Motor Evoked Potential in Healthy Participants: A Double-Blind Randomized Controlled Study. Megía-García, Á., Serrano-Muñoz, D., Taylor, J., et al.[2020]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

Transcutaneous electrical spinal cord stimulation (tSCS) can induce involuntary locomotor-like stepping movements in non-injured humans, suggesting its potential for rehabilitation.

Increasing the frequency of tSCS from 5 to 30 Hz enhances the amplitude of these stepping movements, indicating that tSCS effectively activates locomotor circuitry through the dorsal roots.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcutaneous electrical stimulation of the spinal cord: non-invasive tool for activation of locomotor circuitry in human]. Gorodnichev, RM., Pivovarova, EA., Pukhov, A., et al.[2012]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553154/

Spinal Cord Stimulation - StatPearls - NCBI Bookshelf - NIH This technique uses pulsed electrical energy near the spinal cord to manage pain. This activity reviews the indications, contraindications, equipment, ...

2. withpower.com withpower.com/trial/phase-stiff-person-syndrome-3-2024-409a7

Spinal Cord Stimulation for Stiff Person Syndrome Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06242678/evaluating-spinal-cord-stimulation-for-stiff-person-syndrome

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923005755

Review article Spinal Cord Stimulation: An Update Successful outcome (≥50% pain relief and patient satisfaction with the result) was obtained in 53% of patients at 2.2 years. A systematic review of the ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/papr.13340

Spinal cord stimulation for the symptomatic treatment of ... The novel use of SCS therapy in seropositive SPS resulted in functional improvement and attenuation of symptoms. We present possible mechanisms ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38185725/

Spinal cord stimulation for the symptomatic treatment of ... Conclusions: The novel use of SCS therapy in seropositive SPS resulted in functional improvement and attenuation of symptoms. We present ...

7. curesma.org curesma.org/wp-content/uploads/2025/03/Prat-Ortega-Epidural-spinal-cord-stimulation-in-SMA-Nature-Medicine-2025.pdf

First-in-human study of epidural spinal cord stimulation in ... The primary outcomes aim to assess safety by monitoring adverse events related to SCS use. Participants rate the 'dis- comfort/pain' on a scale of 1 to 10 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT07037628

Investigating the Impact of Spinal Cord Electrical ... This study aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients ...