RECRUITING

Spinal Cord Stimulation for Parkinson's Disease Rehabilitation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-12-12
Study Completion:2035-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06804642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Parkinson's disease;
  2. * Adults aged 18 to 80 years;
  3. * Competent to give informed consent for the research protocol;
  4. * Able to understand instructions;
  5. * Able to ambulate 10-meters.
  1. * Co-morbidities affecting gait;
  2. * Clinically significant cognitive dysfunction;
  3. * Clinically significant depression or major active psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder;
  4. * Terminal illness associated with \<12-month survival;
  5. * Have a current diagnosis or condition such as major cardiac insufficiency, determined clinically by the study doctors;
  6. * Current alcohol or substance abuse that is uncontrolled or unmanageable;
  7. * Individuals unable to communicate with the investigator and study staff; and/or
  8. * 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.

Contacts and Locations

Study Contact

Andrea Wilhite, MS
CONTACT
5025874871
andrea.willhite@louisville.edu
Kristin Benton, MS
CONTACT
5025874871
kristin.benton@louisville.edu

Principal Investigator

Alexander Ovechkin, MD, Ph.D.
STUDY_DIRECTOR
University of Louisville

Study Locations (Sites)

Frazier Rehab Institute
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

  • Alexander Ovechkin, MD, Ph.D., STUDY_DIRECTOR, University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-12
Study Completion Date2035-12-31

Study Record Updates

Study Start Date2024-12-12
Study Completion Date2035-12-31

Terms related to this study

Keywords Provided by Researchers

  • Parkinson disease
  • spinal cord
  • freezing gate
  • rehabilitation
  • non-invasive stimulation
  • neuromodulation

Additional Relevant MeSH Terms

  • Parkinson Disease