RightFit
RecruitingNot applicable

Spinal Cord Stimulation for Parkinson's Disease Rehabilitation

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 month, 2 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Months 1-2: * Intervention 1: Step-scTS in a gravity-neutral device (GND), 3 sessions per week for 1 month. * Post-Intervention 1 Assessments: Conducted following the intervention."
  • "Includes 2 sessions per week of Step-scTS with body-weight support treadmill training (BWS) and 1 session per week of Step-scTS with overground locomotor training using an assistive device, for a total of 3 sessions per week over 2 months. * Post-Intervention 2 Assessments: Conducted following the intervention."
  • "Months 4-6: * Intervention 3: Step-scTS combined with overground locomotor training using an assistive device, 3 sessions per week for 2 months. * Post-Intervention 3 Assessments: Conducted following the intervention"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether electrical stimulation of the spinal cord through the skin, without surgery, can improve walking and balance in people with Parkinson's disease. It also tests stimulation combined with movement training. It is for adults ages 18 to 80 who have Parkinson's disease and can walk 10 meters.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of Parkinson's disease.
  • Be 18 to 80 years old.
  • Be able to understand the study and agree to take part.
  • Be able to understand instructions.
  • Be able to walk 10 meters (about 33 feet).

Who can't join

  • Have other health conditions that affect walking.
  • Have serious problems with thinking or memory.
  • Have serious depression or another major active mental illness, such as schizophrenia or bipolar disorder.
  • Have an illness expected to lead to death in less than 12 months.
  • Have a current condition such as severe heart weakness, as judged by the study doctors.
  • Have current alcohol or drug misuse that is not controlled or cannot be managed.
  • Be unable to communicate with the study team.
  • Have any illness that study doctors think would prevent you from having the stimulation, doing movement training, or taking part in study tests.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

KY