Spinal Cord Stimulation for Parkinson's Disease Rehabilitation
This study is looking at a non-invasive (no surgery needed) treatment called spinal cord transcutaneous stimulation (scTS) for people with Parkinson's disease. scTS uses a device to stimulate the spinal cord through the skin. The goal is to help with walking problems and other movement issues that are not well-controlled by current treatments like levodopa or deep brain stimulation (DBS). Researchers want to see how scTS affects your body's motor responses, using measurements like electromyography (EMG) and electroencephalography (EEG). You might be able to join if you have Parkinson's disease, are between 18 and 80 years old, and can walk 10 meters. The study plans to include 20 participants, but its current status is unclear.
- Study design
- This is an interventional study with 20 planned participants. The study phase is not specified.
- What's involved
- You would train 3 days per week during the intervention periods, aiming for at least 12 sessions. Each session is about 2 hours, including time to place stimulating pads and other sensors.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your motor responses will be assessed from screening until data analysis, for up to 48 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Spinal Cord Stimulation for Parkinson's Disease Rehabilitation
At a glance
Conditions
NCT06804642
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Frazier Rehab Institute
Louisville, Kentuckystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Alexander Ovechkin, MD, Ph.D. · STUDY_DIRECTOR · University of Louisville
Who to contact
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Inclusion
Exclusion
What this trial measures
- A. Assessment of Multisegmental Motor Responses (MMR)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)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)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).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.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.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).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 TestFrom 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)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.