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

Sponsor

Colorado State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05878873

Collaborator

National Multiple Sclerosis Society (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: Split-belt Treadmill Device: Transcutaneous Electrical Nerve Stimulation (TENS)	N/A

Detailed Description

Most people with MS (PwMS) experience significant gait asymmetries between the two legs leading to an increased risk of falls and musculoskeletal injury. The objective of this study is to investigate the neural mechanisms of gait adaptation and the effects of transcutaneous electrical nerve stimulation (TENS) on adaptability during split-belt treadmill training in PwMS. Our hypothesis is that TENS will strengthen sensorimotor integration via amplified afferent signaling, thereby enhancing adaptation, and further improving gait symmetry chronically. Functional near-infrared spectroscopy (fNIRS) will be used during a split-belt treadmill training paradigm to assess cortical activation during gait adaptation. Additionally, the effect of split-belt treadmill training coupled with TENS on gait adaptability in PwMS will be tested with experimental and a sham TENS split-belt treadmill sessions. Cortical activation and the effect of TENS on gait adaptability will be compared between young neurotypical adults and PwMS to assess differences that can be attributed to multiple sclerosis.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

The Neural Underpinnings and the Impact of Wearable Sensory Stimulation During Split-belt Treadmill Adaptation in People With Multiple Sclerosis

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Split-belt Treadmill 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.
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.	Behavioral: Split-belt Treadmill 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. Device: Transcutaneous Electrical Nerve Stimulation (TENS) 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 biceps femoris.

Arm

Intervention/Treatment

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.

Behavioral: Split-belt Treadmill

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.

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.

Behavioral: Split-belt Treadmill

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

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 biceps femoris.

Outcome Measures

Primary Outcome Measures

Change in Cortical Hemodynamics [Baseline session 1 (day 1), training session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), training session 2, and post-training session 2 (day 14)]
The changes of oxygenated hemoglobin in the cortex, a proxy for neuronal activity.
Change in Step Length Asymmetry [Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)]
The difference in the distance covered by each step, a common measure of gait asymmetry, measured using three-dimensional motion capture and force plates.
Change in Phase Coordination Index [Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)]
The accuracy and consistency of step time compared to stride time, measured using three-dimensional motion capture and force plates.

Secondary Outcome Measures

Change in Limb Excursion Asymmetry [Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)]
The anterior-posterior distance traveled by the limb from toe-off to ipsilateral heel strike, measured using three-dimensional motion capture and force plates.
Change in Double Support Percent [Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)]
The percentage of time spent with both feet on the ground during walking, measured using three-dimensional motion capture and force plates.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 86 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

A diagnosis of relapsing remitting multiple sclerosis (ages 18-86) OR a neurotypical young adult (ages 18-30)
Not experiencing an active relapse
Able to stand and walk without an assistive device
Able to walk for three tenths of a mile without stopping to rest