AB Gait Estim Neurophysiology

Official title

Effects of Gait Training Strategies and Noninvasive Stimulation on Neurophysiology and Walking Performance in Able-Bodied Adults- A Preliminary Study

Overview

This study is being done to answer the question: What are the effects of electrical stimulation and stepping practice on connections between the brain and muscles? The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols founded on an understanding of neurobiological mechanisms that combine electrical stimulation with gait training to improve gait performance in older adults and stroke survivors. The rationale of this project is to explore and generate preliminary data regarding how electrical stimulation-based strategies modulate cortical and spinal circuits in able-bodied individuals. The researchers will evaluate the effects of short treadmill walking bouts or single gait training sessions with and without electrical stimulation on somatosensory, spinal-reflex, corticospinal circuit neurophysiology, and/or gait performance. The study will provide important preliminary and normative data that can explain how brain circuits change with stimulation or stepping practice and inform future rehabilitation studies on patients. The study population is able-bodied individuals.

Detailed description

This study is being done to determine the effects of electrical stimulation and walking practice on connections between the brain and muscles.

This study consists of 1-5 study visits lasting up to 5 hours each. Participants will complete stepping training with or without electrical stimulation delivered to their leg muscles; noninvasive stimulation will be delivered to the participants' brain or nerves in the leg to measure the strength of connections within their brain and between their brain / spinal cord and their muscles.

The number of sessions for each participant will depend on whether the same participant completes only 1 or more than 1 study aim.

Interventions

• Other Gait Training
  Gait training: One or multiple short bouts of stepping practice on a treadmill at self-selected or fast speeds will be delivered without FES.
• Device Functional electrical stimulation (FES)
  Electrical stimulation involving the parameters and settings proposed here is commonly used in clinical practice and research for pain relief and other applications also referred to as neuromuscular or transcutaneous electrical nerve stimulation. The FES will be delivered using the UDel Stimulator, a custom-designed FES system from the University of Delaware FES lab. Researchers will use a customized, real-time system to control the stimulator and deliver stimulation during appropriate phases o
• Device Peripheral electrical stimulation paired with cortical magnetic stimulation pulses
  The paired associative stimulation (PAS) will be conducted in a static posture (seated or standing), to evaluate effects on somatosensory, spinal-reflex, and/or corticospinal neurophysiology delivered with different stimulation parameters. One or multiple short bouts of stepping practice on a treadmill at self-selected or fast speeds may be completed before and/or after PAS to evaluate gait performance

Primary outcome measures

• Gait Performance [Time frame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)]
• Corticospinal excitability [Time frame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)]
• Spinal circuit excitability [Time frame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)]

Eligibility criteria

Inclusion criteria

• 18-65 years
• Able-bodied (healthy without any physical disability, neurological, orthopedic, or other medical disorder affecting walking or study protocol participation)
• Ability to walk >10m overground and for 1 minute on a treadmill
• Ability to follow 3-stage commands and provide informed consent.

Exclusion criteria

• Self-reported history or evidence of orthopedic or physical disability
• History or evidence of neurological pathology
• Pregnancy (female)
• Uncontrolled hypertension
• Cardiac pacemaker or other implanted electronic system
• Presence of skin conditions preventing electrical stimulation setup
• Impaired sensation in the left upper limb.
• Bruises or cuts at the stimulation electrode placement site
• Concurrent enrollment in rehabilitation or another investigational study.
• History or evidence of orthopedic or physical disability interfering with study procedures
• History or evidence of neurological pathology or disorder
• Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
• Contraindications to TMS such as metal implants, medications that can increase cortical excitability, unexplained dizziness in the past 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Factorial

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Emory University — Atlanta

Identifiers

NCT: NCT06430164 · STUDY00007235

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗