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

Colorado State University (CSU)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Split-belt Treadmill; Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05878873

1664

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 86 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• A diagnosis of relapsing remitting multiple sclerosis OR a neurotypical adult (ages 18-86)
• 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

Exclusion criteria

• Unable to walk for three tenths of a mile without assistance
• Musculoskeletal injury in past 6 months
• Lower extremity surgery in past 6 months
• Unable to abstain from medications that impair balance
• Currently pregnant
• History of traumatic brain injury
• History of vestibular disease
• History of any other balance impairment unrelated to multiple sclerosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Split-belt Treadmill Training without TENS

Sham Comparator group

Description:

During this arm, participants will perform split-belt treadmill training with sensory stimulation equipment outfitted but not active during all adaptation sessions.

Treatment:

Behavioral: Split-belt Treadmill

Split-belt Treadmill Training with TENS

Experimental group

Description:

During this arm, participants will perform split-belt treadmill training with active sensory stimulation occuring simultaneously during all adaptation sessions.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation (TENS)

Behavioral: Split-belt Treadmill