NCT06804642 · University of Louisville
Spinal Cord Stimulation for Parkinson's Disease Rehabilitation
What this study is about
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.
View original scientific 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.
Interventions
DEVICE
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 measures
A. Assessment of Multisegmental Motor Responses (MMR)
Time frame: From date of screening until the date of data is analyzed, up to 48 months.
Multisegmental motor responses in different leg muscles evoked by non-invasive stimulation of the dorsal lumbosacral spinal cord will be recorded. Such responses are the basic components of the lower-limb muscle responses that are elicited by transcutaneous stimulation of posterior lumbar cord structures. Multi-Segmental Motor Responses will be evoked transcutaneously by using a constant current stimulator (Cosyma, Inc. or Digitimer-Constant Current Stimulator, e.g., DS8R) between the C2 spinous process and the Coccyx. Small cathodes (pre-gelled, soft surface electrodes) will be placed over the skin between the C2 spinous process and Coccyx (midline with a single cathode or left and right of midline with a split cathode) while larger anode(s) will be placed over the anterior spine at different levels, at segments just below the cathode, on the abdomen, or along the pelvis.
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.
Mapping will be carried out through assessment of electrophysiological and functional changes. EMG will be used to assess muscle activity. The mapping assessment may take place with the participant in supine, side-lying in a gravity-neutral device, upright while standing, or upright while stepping. Assistance will be provided as needed. A safety limit of 250 mA will be implemented. Other stimulation parameters include: 5-10 kHz carrier frequency for modulation of discomfort from stimulation, 0.25-3.0 ms pulse width duration, and 10-100 Hz.
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.
Mapping will be carried out through assessment of electrophysiological and functional changes. EEG will be used to assess brain activity. The mapping assessment may take place with the participant in supine, side-lying in a gravity-neutral device, upright while standing, or upright while stepping. Assistance will be provided as needed. A safety limit of 250 mA will be implemented. Other stimulation parameters include: 5-10 kHz carrier frequency for modulation of discomfort from stimulation, 0.25-3.0 ms pulse width duration, and 10-100 Hz.
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.
Limb coordination and muscle activation during visual imaginary stepping and gravity-neutral ambulation will be assessed with surface EMG of multiple trunk and lower extremity muscles including pelvic stabilizers (quadratus lumborum), hip extensors (gluteus), hip flexors (iliopsoas), knee extensor (rectus femoris), knee flexor (biceps femoris), ankle dorsiflexor (tibialis anterior), and ankle plantar flexor (medial gastrocnemius and soleus) without and with scTS.
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.
Limb coordination during visual imaginary stepping and gravity-neutral ambulation will be assessed with gait kinematics determined with goniometers at the top arm, hip, knee, and/or ankle and/or with 3D motion capture.
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.
Limb coordination during visual imaginary stepping and gravity-neutral ambulation will be assessed with plantar pressure stimulation (Korvit) to be used based on participant presentation. When used, pressure sensing insoles (Noraxon Ultium) will be placed in orthotics to track inflation under the heel and forefoot and synchronize with other data types.
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.
EEG will be recorded before, during, and after scTS. Cortical activity will be correlated with gait performance/limb kinematics.
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.
The Tinetti Balance and Gait Test, also known as the performance-oriented mobility assessment, uses a standardized scoring system to assess participants' balance and gait. The examiner will be near the participant during each part of the assessment in case the participant exhibits any risk of falling. Scoring is ordinal with a range from 0 to 2; 0 indicates severe impairment and 2 indicates independence. For the balance assessment, the participant starts in a seated position on a hard, armless, stable chair and is instructed to rise from seated without using their arms or hands. Once standing, the participant is instructed to move their feet as close together as possible. The examiner then presses on the participant's sternum with their palm three times while the participant's eyes are open and three times while the participant's eyes are closed. During the last component of the balance assessment, the participant is asked to make a 360-degree turn and sit back in the chair.
New Freezing of Gait Questionnaire (NFOG-Q)
Time frame: From date of screening until the date of data is analyzed, up to 48 months.
The Freezing of Gait Questionnaire is a six-item scale (range 0-24); four items assess FOG severity, and two items assess general gait difficulties. The New Freezing of Gait Questionnaire was developed to address limitations of the original questionnaire. The NFOG-Q adds an initial item to the original questionnaire; based on the answer to this initial item, part II includes questions about FOG severity, and part III includes questions about impact. The NFOG-Q was found to be test-retest reliability and high agreement between patients with Parkinson's disease and their carers.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Louisville, Kentucky
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations