The Neural Mechanisms of Split-belt Treadmill Adaptation in People With Multiple Sclerosis

Part of paid clinical trials in Fort Collins, Colorado.

Sponsor
Colorado State University
Study ID
NCT05878873
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 86 Years
Healthy Volunteers
Accepted

Interventions

  • Split-belt Treadmill — BEHAVIORAL
    Split-belt treadmill training, where the speed of each leg is controlled independently has been shown to create gait adaptation where the coordination of each leg is altered, creating improved gait symmetry for people with walking impairments.
  • Transcutaneous Electrical Nerve Stimulation (TENS) — DEVICE
    TENS is a form of nerve stimulation that stimulates at a frequency below motor threshold, targeting activation of sensory receptors, such as muscle spindles. Electrodes that create this stimulation will be placed on the skin superficial to the muscle bellies of the tibialis anterior and rectus femoris.

Study Details

Majority of people with multiple sclerosis experience difficulty with balance and mobility, leading to an increased risk of falls. The goal of this clinical trial is to learn about brain activity during walking adaptation in people with multiple sclerosis. Also, this clinical trial will test a form of nerve stimulation to see if it can improve walking performance. The main questions it aims to answer are: * What areas of the brain are the most active during walking adaptation? * Can nerve stimulation make walking adaptation more effective? Participants will walk on a treadmill where each leg will go a different speed which will create walking adaptation. At the same time, brain scans will occur. There will be two sessions of walking adaptation, one with nerve stimulation, and one without nerve stimulation. Researchers will compare people with multiple sclerosis to healthy young adults to see if there are differences in brain activity.

Key Dates

Start date
Nov 28, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Split-belt Treadmill Training without TENS
    During this arm, participants will perform split-belt treadmill training with sensory stimulation equipment outfitted but not active during all adaptation sessions.
  • Experimental: Split-belt Treadmill Training with TENS
    During this arm, participants will perform split-belt treadmill training with active sensory stimulation occuring simultaneously during all adaptation sessions.

Primary Outcome Measure

Change in Cortical Activation [ Time Frame: Training session 1 (day 1), training session 2 (day 28) ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Sensorimotor Neuroimaging LaboratoryFort CollinsColorado80523-

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