Understanding Electrical Stimulation and Walking Practice on Brain-Muscle Connections

This study, NCT06430164, is exploring how electrical stimulation and walking practice affect the connections between your brain and muscles. Researchers are using gait training (walking on a treadmill) and two types of electrical stimulation: Functional Electrical Stimulation (FES) to leg muscles, and Peripheral Electrical Stimulation paired with Cortical Magnetic Stimulation pulses to measure brain-muscle connections. The goal is to understand how these methods might improve walking in the future for people like older adults or stroke survivors. You might be eligible if you are 18-65 years old, healthy, can walk at least 10 meters, and can follow instructions. The study aims to measure your walking performance and the excitability (how easily they can be activated) of your brain and spinal cord circuits before, during, and after the interventions. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 50 healthy participants. It is not specified if it is randomized or blinded.
What's involved
You would have 1-5 study visits, each lasting up to 5 hours. You will participate in stepping training with or without electrical stimulation to your leg muscles, and noninvasive stimulation to your brain or leg nerves.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken pre-test, during the test (up to 36 minutes), and post-test (up to 60 seconds).

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NCT06430164

AB Gait Estim Neurophysiology

Recruiting
NAAges 18–65Interventional
Emory University
~50 participants
Updated 2025-07-28 on ClinicalTrials.gov
What's tested:Gait TrainingFunctional electrical stimulation (FES)Peripheral electrical stimulation paired with cortical magnetic stimulation pulses

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gait Performance
Measured over Pretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)
+2 more outcomes measured
Gait
1 sites across 1 states
Georgia1
  • Trisha Kesar, PT, PhD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

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
  • Gait PerformancePretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)

    Marker data will be collected using a 7-camera motion analysis system at 120 Hz (Vicon, Oxford, UK). During treadmill walking, ground reaction forces during the treadmill walking will be collected using a treadmill instrumented with two 6-component force platforms under each belt (Bertec, USA). Ground reaction forces will be evaluated using a force plate embedded within the lab floor (AMTI, USA).

  • Corticospinal excitabilityPretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)

    Corticospinal excitability will be assessed using a non-invasive technique called transcranial magnetic stimulation (TMS). TMS will be delivered using MagStim Stimulators with a double circular coil, custom-built double-cone, or batwing coil (Magstim Ltd, Wales, UK). Electrical activity from muscles in response to the TMS will be collected using surface EMG electrodes attached to muscles that play critical roles during walking (e.g., quadriceps femoris, tibialis anterior, soleus, gastrocnemius, hamstrings, etc.). In addition, EMG signals may be recorded from a couple of upper extremity muscles (e.g., first dorsal interosseus, flexor digitorum indicis) to be used as a control.

  • Spinal circuit excitabilityPretest (up to 60 seconds), during test (up to 36 minutes), post-test (up to 60 seconds)

    Spinal excitability may be assessed using peripheral electrical stimulation delivered to the nerves innervating the ankle muscles. The methods for electrical stimulation are similar to those used for delivering functional electrical stimulation except that the subjects are seated and the stimulation is used to obtain outcome measures assessing spinal excitability. Muscles of interest are the soleus and medial gastrocnemius (calf muscles), and tibialis anterior (front of lower leg). EMG activity will be recorded while 50-60 electrical stimuli (short 1 ms square pulses, ranging in intensity from 1mA - 80 mA), 7-10 seconds apart, are delivered to the muscle. Researchers may also deliver 5-20 electrical stimulus pulses at intensities that elicit a percentage of the maximum reflex response.