Clinical trial NCT06430164: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait
Keywords: Corticospinal excitability
Non-invasive stimulation
Functional electrical stimulation (FES)
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Gait Performance
timeFrame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
measure: Corticospinal excitability
timeFrame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
measure: Spinal circuit excitability
timeFrame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
Secondary outcomes:
Other outcomes:
measure: Muscle activity during gait
timeFrame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
measure: Somatosensory excitability
timeFrame: Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Trisha Kesar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: