Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT06430164

Conditions

Gait

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Gait Training

Functional electrical stimulation (FES)

Peripheral electrical stimulation paired with cortical magnetic stimulation pulses

Study Details

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.

Conditions

Gait

Study ID

NCT06430164

Start date

Feb 12, 2024

Status verified date

Jul, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Gait with functional electrical stimulation

Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill with functional electrical stimulation, and non-invasive measurement of neural circuit excitability.

Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).

experimental: Gait without functional electrical stimulation

Participants will participate in 2 to 5 sessions over 2-8 weeks. Each session will comprise gait or stepping practice on a treadmill without functional electrical stimulation, and non-invasive measurement of neural circuit excitability.

Participants will complete multiple 30-second to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts. For gait training, participants may complete up to six 6-minute bouts of walking with rest breaks between bouts (30-36 minutes walking).

experimental: Paired stimulation of the cortex and peripheral nervous system

Participants will participate in a single session of peripheral electrical stimulation paired with cortical stimulation pulses (i.e. paired associative stimulation(PAS)) on somatosensory, spinal-reflex, and corticospinal neurophysiology.

Interventions

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.

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 of the gait cycle. Stimulation will be delivered to the ankle dorsiflexors when the subject's foot is in the air (swing phase). Stimulation will be delivered to the ankle plantarflexors during the terminal stance phase of gait. 30-Hz variable frequency stimulation trains will be delivered during gait.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Trisha Kesar, PT, PhD

404-712-5803tkesar@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

More Information

Sponsor

Emory University

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Keywords

  • Corticospinal excitability
  • Non-invasive stimulation
  • Functional electrical stimulation (FES)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-07-28.