Spinal Cord Stimulation for Parkinson's Disease Rehabilitation

NCT06804642 | Recruiting FDA Device

• 1 other identifier: 24-0700
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

• 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.
• Improving Postural Networks
• 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).

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (9)

• A. Assessment of Multisegmental Motor Responses (MMR)

  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.

  From date of screening until the date of data is analyzed, up to 48 months.

• Spinal Cord Transcutaneous Stimulation (scTS) Mapping electromyography (EMG)

  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.

  From date of screening until the date of data is analyzed, up to 48 months.

• Spinal Cord Transcutaneous Stimulation (scTS) Mapping electroencephalography (EEG)

  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.

  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).

  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.

  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.

  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.

  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.

  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.

  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).

  EEG will be recorded before, during, and after scTS. Cortical activity will be correlated with gait performance/limb kinematics.

  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

  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.

  From date of screening until the date of data is analyzed, up to 48 months.

• New Freezing of Gait Questionnaire (NFOG-Q)

  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.

  From date of screening until the date of data is analyzed, up to 48 months.

Secondary Outcomes (5)

• Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  From date of screening until the date of data is analyzed, up to 48 months.

• Time to Navigate (TTN) Test

  From date of screening until the date of data is analyzed, up to 48 months.

• Modified Ashworth Scale (MAS) and Range of Motion (ROM) Testing

  From date of screening until the date of data is analyzed, up to 48 months.

• 10-Meter Walk Test

  From date of screening until the date of data is analyzed, up to 48 months.

• 6-Minute Walk Test

  From date of screening until the date of data is analyzed, up to 48 months.

Other Outcomes (14)

• Propriospinal Pathway Assessment (PSPA)

  From date of screening until the date of data is analyzed, up to 48 months.

• Supraspinal Connectivity Assessment (SSCA)

  From date of screening until the date of data is analyzed, up to 48 months.

• Reticulospinal Pathway Assessment (RSPA)

  From date of screening until the date of data is analyzed, up to 48 months.

Study Arms (1)

Non-invasive spinal neuromodulation training

EXPERIMENTAL

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.

Device: Spinal cord transcutaneous stimulation (scTS)

Interventions

Spinal cord transcutaneous stimulation (scTS) DEVICE

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

Non-invasive spinal neuromodulation training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Frazier Rehab Institute

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Alexander Ovechkin, MD, Ph.D.

  University of Louisville

  STUDY DIRECTOR

Central Study Contacts

Andrea Wilhite, MS

CONTACT

5025874871; andrea.willhite@louisville.edu

Kristin Benton, MS

CONTACT

5025874871; kristin.benton@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: February 3, 2025
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 11, 2029
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)