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NCT06804642Recruiting

Spinal Cord Stimulation for Parkinson's Disease Rehabilitation

Rehabilitation of Locomotor Function in Parkinson's Disease by Non-invasive Spinal Cord Stimulation

Source: ClinicalTrials.gov · Last updated 11 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
18 Dec 2024
Start date
12 Dec 2024
Primary completion date
11 Dec 2029
Lead sponsor
University of Louisville
NCT number
NCT06804642

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 12 Dec 2024 to the primary completion date, 11 Dec 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;
  • 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.

Other

  • Co-morbidities affecting gait;
  • Clinically significant cognitive dysfunction;
  • Current alcohol or substance abuse that is uncontrolled or unmanageable;
  • Individuals unable to communicate with the investigator and study staff; and/or

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Frazier Rehab Institute
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.