Spinal Cord Stimulation for Parkinson's Disease Rehabilitation
Recruiting
N/AInterventional Study
Parkinson Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
University of Louisville · Other
Who this trial is looking for
This trial is looking for adults with Parkinson's disease to test a treatment called spinal cord transcutaneous stimulation. Participants will help researchers understand how this treatment may improve walking and balance.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's disease
I am between 18 and 80 years old
I can give informed consent for the research
I can follow instructions
I can walk 10 meters
You may not be able to join if
I have other health issues that affect my walking
I have serious cognitive problems
I have major depression or another serious mental illness
I have a terminal illness with less than 12 months to live
I have significant heart problems
I have uncontrolled alcohol or substance abuse
I cannot communicate with the study staff
I have an illness that could prevent me from participating
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 limitati…
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.
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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 cogn…
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.
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