Spinal Cord Stimulation for Parkinson's Disease Rehabilitation

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT06804642
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Spinal cord transcutaneous stimulation (scTS) — DEVICE
    scTS mapping: Each intervention session will be approximately 2 hours each which includes time to place the scTS stimulating pads and other sensors as needed. Participants will be asked to train 3 days per week during the intervention periods so that they achieve at least 12 sessions. In instances in which availability is limited or they must cancel a session, the intervention period will need to be extended slightly (up to a maximum of four weeks) so that they can achieve at least 12 sessions (1-month intervention period) or 24 sessions (2-month intervention periods) of training. The main study interventions are described below. Step-scTS: Step-scTS is spinal cord transcutaneous stimulation (scTS) targeted for stepping function. The scTS mapping assessment(s) will assist the study team in determining optimized stimulation parameters for each body and f

Study Details

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.

Key Dates

Start date
Dec 12, 2024
Status verified
Mar 2026
Primary completion
Dec 11, 2029
Completion
Dec 31, 2035

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Non-invasive spinal neuromodulation training
    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.

Primary Outcome Measure

A. Assessment of Multisegmental Motor Responses (MMR) [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Frazier Rehab InstituteLouisvilleKentucky40202
Alexander Ovechkin, MD, Ph.D.
[email protected]
5025818675
Andrea Wilhite, MS
[email protected]
5025874871
Peter Hedera, MD, Ph.D. (SUB_INVESTIGATOR)
Victoria Holiday, MD (SUB_INVESTIGATOR)
Nelleke Van Wouwe, Ph.D. (SUB_INVESTIGATOR)
Alexander Ovechkin, MD, Ph.D. (SUB_INVESTIGATOR)
Ajmal Zemmar, MD, Ph.D. (PRINCIPAL_INVESTIGATOR)
Yury Gerasimenko, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Louisville, KY

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Frazier Rehab Institute· Louisville, KY

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