Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2024-02-12
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait
NCT07189819
Epidural Spinal Cord Stimulation for Restoring Walking in Spinal Cord Injury
NCT07306052
Transspinal Stimulation Plus Locomotor Training for SCI
NCT04807764
Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis
NCT02152085
FES-assisted Gait Intervention in People with Spinal Cord Injury - Pilot Study
NCT05908175
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
FACTORIAL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
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).
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.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emory University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Trisha Kesar
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Trisha Kesar, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University
Atlanta, Georgia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00007235
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.