Recruiting

scTS

Sponsor:

University of Louisville

Code:

NCT06804642

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal cord transcutaneous stimulation (scTS)

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT06804642

Start date

Dec 12, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 11, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Spinal cord transcutaneous stimulation (scTS)

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

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. ]
  • Spinal Cord Transcutaneous Stimulation (scTS) Mapping electromyography (EMG) [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]
  • Spinal Cord Transcutaneous Stimulation (scTS) Mapping electroencephalography (EEG) [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]
  • Stepping Performance in a Gravity-Neutral Device (GND) with electromyography (EMG). [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]
  • Stepping Performance in a Gravity-Neutral Device (GND) with kinematics. [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]
  • Stepping Performance in a Gravity-Neutral Device (GND) with plantar stimulation. [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]
  • Stepping Performance in a Gravity-Neutral Device (GND) with electroencephalography (EEG). [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]
  • D. Assessment of Balance and Gait: Tinetti Balance & Gait Test, Rating Instrument to Assess Festination and Freezing Gait, and Push & Release Test [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]
  • New Freezing of Gait Questionnaire (NFOG-Q) [ Time Frame: From date of screening until the date of data is analyzed, up to 48 months. ]

Central Contacts and Locations

Central contacts

Andrea Wilhite, MS

5025874871andrea.willhite@louisville.edu

Kristin Benton, MS

5025874871kristin.benton@louisville.edu

Locations

Frazier Rehab Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Alexander Ovechkin, MD, Ph.D.

5025818675avovec02@louisville.edu

Andrea Wilhite, MS

5025874871andrea.willhite@louisville.edu

Principal Investigator:

Ajmal Zemmar, MD, Ph.D.

More Information

Sponsor

University of Louisville

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Louisville on 2026-03-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.