NCT06804642 Spinal Cord Stimulation for Parkinson's Disease Rehabilitation
| NCT ID | NCT06804642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Louisville |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-12 |
| Primary Completion | 2029-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-12-12 with a primary completion date of 2029-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Parkinson's disease; * Adults aged 18 to 80 years; * Competent to give informed consent for the research protocol; * Able to understand instructions; * Able to ambulate 10-meters. Exclusion Criteria: * Co-morbidities affecting gait; * Clinically significant cognitive dysfunction; * Clinically significant depression or major active psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder; * Terminal illness associated with \<12-month survival; * Have a current diagnosis or condition such as major cardiac insufficiency, determined clinically by the study doctors; * Current alcohol or substance abuse that is uncontrolled or unmanageable; * Individuals unable to communicate with the investigator and study staff; and/or * Individuals with any illness that, in the study doctors' opinion, may preclude them from spinal cord transcutaneous stimulation, activity-based recovery training, or participation in study assessments.
Contact & Investigator
Alexander Ovechkin, MD, Ph.D.
STUDY DIRECTOR
University of Louisville
Frequently Asked Questions
Who can join the NCT06804642 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06804642 currently recruiting?
Yes, NCT06804642 is actively recruiting participants. Contact the research team at andrea.willhite@louisville.edu for enrollment information.
Where is the NCT06804642 trial being conducted?
This trial is being conducted at Louisville, United States.
Who is sponsoring the NCT06804642 clinical trial?
NCT06804642 is sponsored by University of Louisville. The principal investigator is Alexander Ovechkin, MD, Ph.D. at University of Louisville. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.