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 trial explores a non-invasive treatment called spinal cord transcutaneous stimulation (scTS) to help people with Parkinson's disease improve their walking and balance. The focus is on addressing gait problems, which current treatments often do not manage well. Participants should have Parkinson's disease and be able to walk 10 meters. This research could lead to a new method for easing movement issues in Parkinson's, potentially enhancing quality of life. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could transform Parkinson's treatment.

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.

What prior data suggests that this spinal cord transcutaneous stimulation is safe for Parkinson's disease patients?

In a previous study, researchers found that spinal cord transcutaneous stimulation (scTS) is generally safe for people with Parkinson's disease and can improve their quality of life. Another study tested the safety and effectiveness of using scTS at multiple sites along with activity-based therapy. This study found that the treatment was well-tolerated, with no serious side effects.

Although the FDA has not approved scTS for Parkinson's, it has been safely used for other conditions like spinal cord injuries. This suggests it is generally safe, but all treatments can have risks. Since scTS is non-invasive and doesn't involve surgery, it reduces certain risks and presents a promising option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord transcutaneous stimulation (scTS) for Parkinson's disease because it offers a non-invasive way to potentially improve movement and posture. Unlike standard treatments like medications that focus on managing symptoms through chemical means, scTS uses electrical stimulation to activate specific spinal networks. This approach aims to enhance the body’s own ability to control gait and balance by modulating nerve signals, which could provide benefits beyond what current therapies offer. This innovative method might pave the way for new rehabilitation strategies that directly target the nervous system to improve quality of life for people with Parkinson's.

What evidence suggests that spinal cord transcutaneous stimulation is effective for Parkinson's disease?

Research has shown that spinal cord transcutaneous stimulation (scTS) may improve walking in individuals with conditions such as spinal cord injury, stroke, and cerebral palsy. This non-invasive technique stimulates specific spinal areas to enhance movement. In this trial, participants will undergo non-invasive spinal neuromodulation training using scTS. While traditional spinal cord stimulation (SCS) has produced mixed results in treating Parkinson's disease (PD), early studies suggest scTS might help manage motor symptoms, particularly those unresponsive to treatments like levodopa. By activating certain spinal networks, scTS could enhance walking and posture in PD patients. Although further research is necessary, this method might offer a safe and flexible treatment for walking difficulties in PD. ^{1 6 7 8 9}

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) 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) 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) 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]

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]

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]

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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11351408/

New Perspectives for Spinal Cord Stimulation in Parkinson's ... In a most recent case report, Milekovic et al. were able to demonstrate that activity-dependent SCS improved gait in a PD patient, thus having ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000976

A review of the effects of spinal cord stimulation on motor ... The findings suggest that SCS may offer a promising alternative for managing motor symptoms in PD, especially for those resistant to levodopa ...

3. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.30187?af=R

Spinal Cord Stimulation Failed to Improve Parkinson's ... No statistically significant effect of SCS was identified in any outcome at any point in the study. When comparing active and sham stimulation ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9912734/

Spinal Cord Stimulation for Gait Disorders in Parkinson's ... SCS may have a therapeutic potential in advanced PD patients suffering from postural and gait-related symptoms.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05148468

Effects of Spinal Cord Stimulation on Gait in Patients With ... Spinal cord stimulation (SCS) for Parkinson´s disease (PD) has been studied for a decade but consensus on efficacy is still lacking, with the previous ...

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

Safety and Effectiveness of Multisite Transcutaneous ... Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) in ...

7. trialx.com trialx.com/clinical-trials/listings/295946/spinal-cord-stimulation-for-parkinsons-disease-rehabilitation/

Spinal Cord Stimulation for Parkinson's Disease ... This study explores the use of multifunctional, non-invasive spinal cord transcutaneous stimulation (scTS) to address axial motor symptoms, ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04783493

Transcutaneous Magnetic Spinal Cord Stimulation for ... The present study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will assess the efficacy and safety of ...

9. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.