Spinal Cord Stimulation for Parkinson's Disease

Overseen By Kristin Benton, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Cognitive dysfunction, Depression, Cardiac insufficiency, others

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

Compensation: Varies

Number of Visits: 64

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study explores the use of multifunctional, non-invasive spinal cord transcutaneous stimulation (scTS) to address axial motor symptoms, particularly gait dysfunction, in Parkinson's disease (PD). These symptoms, resistant to levodopa and inadequately managed by deep brain stimulation (DBS), arise from maladaptive spinal network changes. A non-invasive approach like scTS could overcome limitations associated with invasive spinal cord stimulation (SCS), which requires surgical implantation and lacks adaptability in stimulation site adjustments. Gait dysfunction in PD stems from disrupted interactions between spinal and supraspinal networks. scTS provides a non-invasive alternative, shown to enhance locomotor functions in conditions such as spinal cord injury, stroke, and cerebral palsy. This study hypothesizes that scTS applied at multiple spinal levels-cervical (C3-C4), thoracic (T11-T12), and lumbar (L1, L2-L3)-can synergistically activate locomotor central pattern generators (CPGs) and improve gait and postural control in PD. Additionally, it is hypothesized that proprioceptive input, combined with scTS, can counteract disruptions in spinal networks and restore voluntary movement. The primary goal is to evaluate the effects of scTS on stepping performance, postural control, and locomotor recovery in PD. Specific objectives include: 1. Enhancing Locomotor Networks * Determine optimal scTS parameters for inducing rhythmic stepping in PD patients. * Assess interactions between spinal and supraspinal networks during imagined stepping under scTS in a gravity-neutral setting. 2. Improving Postural Networks o Evaluate the effectiveness of scTS in restoring postural control and integrating postural-locomotor functions. 3. Facilitating Neuroplasticity for Movement Recovery o Combine scTS with activity-based recovery training to promote adaptive plasticity in spinal and cortical networks, reducing freezing of gait (FOG). The research will measure scTS's capacity to generate coordinated stepping and postural movements, integrate proprioceptive feedback, and induce long-term improvements in gait parameters. By targeting spinal locomotor and postural systems, scTS offers a novel, non-invasive approach to addressing gaps in the management of PD gait dysfunction. This work has the potential to significantly enhance the quality of life for individuals with PD, providing a safe, adaptable, and patient-centered therapeutic solution.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctors to get a clear answer.

Is spinal cord stimulation safe for humans?

Spinal cord stimulation (SCS) has been used in various studies for Parkinson's disease and other conditions, showing positive outcomes in managing symptoms like pain and gait issues. While the evidence is still limited, SCS is generally considered safe, with ongoing research to better understand its long-term effects and optimal use. ^{1 2 3 4 5}

How does spinal cord transcutaneous stimulation (scTS) differ from other treatments for Parkinson's disease?

Spinal cord transcutaneous stimulation (scTS) is unique because it is a non-invasive treatment that targets the spinal cord to help manage symptoms of Parkinson's disease, unlike traditional treatments like medication or deep brain stimulation (DBS) which are more invasive. This approach may improve motor symptoms and quality of life by modulating the nervous system in a way that other treatments do not. ^{4 5 6 7 8}

What data supports the effectiveness of the treatment Spinal cord transcutaneous stimulation (scTS) for Parkinson's Disease?

Research shows that spinal cord stimulation (SCS) can improve walking, motor symptoms, and quality of life in Parkinson's patients, even those with symptoms that don't respond to medication. SCS is also effective for chronic pain and has shown benefits in movement disorders, suggesting potential for Parkinson's treatment. ^{1 4 5 6 7}

Who Is on the Research Team?

Alexander Ovechkin, MD, Ph.D.

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who experience gait dysfunction that isn't well-managed by medication or deep brain stimulation. It's not suitable for those with dementia or other conditions that might interfere with the treatment.

Inclusion Criteria

I understand and can agree to the study's requirements.

I can walk 10 meters on my own.

Able to understand instructions

Exclusion Criteria

Clinically significant cognitive dysfunction

I have health conditions that affect my ability to walk.

My heart is not working well, as confirmed by doctors.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo a detailed medical evaluation and baseline assessments prior to interventions

1 day

1 visit (in-person)

Intervention 1

Step-scTS in a gravity-neutral device, 3 sessions per week for 1 month

1 month

12 visits (in-person)

Intervention 2

Combination of Step-scTS and locomotor training, 3 sessions per week for 2 months

2 months

24 visits (in-person)

Intervention 3

Step-scTS combined with overground locomotor training using an assistive device, 3 sessions per week for 2 months

2 months

24 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Spinal cord transcutaneous stimulation (scTS)

Trial Overview The study tests non-invasive spinal cord transcutaneous stimulation (scTS) at various spinal levels to improve walking and balance in Parkinson's patients. It aims to activate locomotor patterns and enhance postural control without surgery.

How Is the Trial Designed?

Group I: Non-invasive spinal neuromodulation training Experimental Treatment 1 Intervention

The overall strategy outlined in this proposal is based on previous data from our own group reporting gait improvement in SCI individuals through activation of spinal locomotor networks located in the lumbosacral region that bear the capability of generating full weight-bearing stepping when epidural stimulation is combined with transcutaneous stimulation of the cervical spinal cord (Angeli \& Gerasimenko, 2023). Building on our knowledge from SCI patients, the approach in the present study will be to modulate the ascending proprioceptive fibers important for feedback and posture control and to overcome disruptive signals from descending systems, which presumably occur in PD individuals (Sarica et al., 2023), by taking advantage of the intrinsic abilities of the lumbosacral spinal network to generate stepping. This is a prospective non-blinded non-randomized study. All data will be stored for off-line analysis.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

Spinal cord stimulation (SCS) showed a significant reduction in motor symptoms for Parkinson's disease patients, with an average decrease of 4.43 points on the Unified Parkinson Disease Rating Scale-III (UPDRS-III), indicating a 14% improvement.

SCS also effectively reduced pain, with a 59% decrease in Visual Analogue Scale (VAS) scores for back and leg pain, suggesting it may provide substantial pain relief in addition to motor benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for Parkinson's Disease: A Systematic Review and Meta-Analysis of Pain and Motor Outcomes. Sarica, C., Zemmar, A., Yousefi, O., et al.[2023]

Spinal cord stimulation (SCS) significantly reduced pain in Parkinson's Disease patients, with an average reduction of 59% in Visual Analogue Scale (VAS) scores across 15 participants, and up to 67% for those using cycling burst stimulation.

SCS also improved motor symptoms, with 73% of patients showing better performance in a 10-meter walking test and 64% experiencing clinically relevant improvements in the Timed Up and Go (TUG) test, indicating its potential as a treatment option for both pain and motor issues in Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single arm prospective multicenter case series on the use of burst stimulation to improve pain and motor symptoms in Parkinson's disease. Chakravarthy, KV., Chaturvedi, R., Agari, T., et al.[2022]

Spinal cord stimulation (SCS) is an effective treatment for chronic neuropathic pain and has shown promising results in improving gait and symptoms in patients with movement disorders like Parkinson's disease, based on recent clinical studies.

The therapy's ability to modulate neural networks in the spinal cord suggests it could also be beneficial for other conditions such as essential tremor and ataxia, highlighting its potential as a versatile treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments for spinal cord stimulation. Cury, RG., Moro, E.[2022]

Spinal cord stimulation (SCS) is a safe and effective surgical treatment for chronic neuropathic pain, particularly beneficial for patients with Parkinson's disease.

Tonic SCS has been shown to improve gait disorders, motor symptoms, and overall quality of life in Parkinson's patients, even those who do not respond to dopamine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tonic spinal cord stimulation as therapeutic option in Parkinson disease with axial symptoms: Effects on walking and quality of life. Hubsch, C., D'Hardemare, V., Ben Maacha, M., et al.[2020]

Spinal cord stimulation (SCS) therapy shows promise as a treatment for Parkinson's disease symptoms, with positive outcomes reported from both cervical and thoracic stimulation techniques.

Current research suggests that SCS may serve as a salvage therapy for patients who do not respond to deep brain stimulation (DBS), indicating its potential role in managing Parkinson's disease as part of a broader therapeutic strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in Parkinson's disease: a review of the preclinical and clinical data and future prospects. Cai, Y., Reddy, RD., Varshney, V., et al.[2020]

A case study of a 73-year-old man with Parkinson's disease demonstrated that spinal cord stimulation (SCS) significantly improved his pain and gait, with pain relief measured at 81% and gait improvement at 45% after a second surgery to correct a lead dislocation.

The study suggests that low-frequency SCS can effectively alleviate pain and gait issues in Parkinson's patients, as the improvements were not due to a placebo effect, evidenced by the patient's quality of life increasing by 40% after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation with Surgical Lead Improves Pain and Gait in Parkinson's Disease after a Dislocation of Percutaneous Lead: A Case Report. Lai, Y., Pan, Y., Wang, L., et al.[2021]

Spinal cord stimulation (SCS) shows promise in improving levodopa-resistant motor symptoms in Parkinson's disease, with 18 out of 24 patients experiencing improvements in their motor scores after treatment.

Despite positive results, the evidence is limited due to the small number of studies and participants, highlighting the need for further long-term research to determine the best candidates and stimulation parameters for SCS in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for Parkinson's disease: a systematic review. de Andrade, EM., Ghilardi, MG., Cury, RG., et al.[2018]

In a study involving 37 Parkinson's disease patients with camptocormia, repetitive trans-spinal magnetic stimulation (rTSMS) significantly reduced the thoracolumbar spine flexion angle by an average of 10.9° immediately after treatment, indicating its potential efficacy in addressing this postural abnormality.

The effects of rTSMS were transient, suggesting that while it provides immediate benefits, further research is needed to determine if repeated treatments can lead to longer-lasting improvements in camptocormia for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate effect of spinal magnetic stimulation on camptocormia in Parkinson's disease. Arii, Y., Sawada, Y., Kawamura, K., et al.[2022]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation for Parkinson's Disease: A Systematic Review and Meta-Analysis of Pain and Motor Outcomes. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Single arm prospective multicenter case series on the use of burst stimulation to improve pain and motor symptoms in Parkinson's disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

New developments for spinal cord stimulation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Tonic spinal cord stimulation as therapeutic option in Parkinson disease with axial symptoms: Effects on walking and quality of life. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in Parkinson's disease: a review of the preclinical and clinical data and future prospects. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation with Surgical Lead Improves Pain and Gait in Parkinson's Disease after a Dislocation of Percutaneous Lead: A Case Report. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for Parkinson's disease: a systematic review. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Immediate effect of spinal magnetic stimulation on camptocormia in Parkinson's disease. [2022]