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

Primary Purpose

Multiple Sclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Split-belt Treadmill
Transcutaneous Electrical Nerve Stimulation (TENS)
Sponsored by
Colorado State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring split-belt treadmill, adaptation, multiple sclerosis, functional near-infrared spectroscopy, cortical activation, gait asymmetry, locomotion, sensorimotor control

Eligibility Criteria

18 Years - 86 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • The Sensorimotor Neuroimaging Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Split-belt Treadmill Training without TENS

Split-belt Treadmill Training with TENS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Cortical Hemodynamics
The changes of oxygenated hemoglobin in the cortex, a proxy for neuronal activity.
Change in Step Length Asymmetry
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
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
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
The percentage of time spent with both feet on the ground during walking, measured using three-dimensional motion capture and force plates.

Full Information

First Posted
May 12, 2023
Last Updated
October 13, 2023
Sponsor
Colorado State University
Collaborators
National Multiple Sclerosis Society
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1. Study Identification

Unique Protocol Identification Number
NCT05878873
Brief Title
The Neural Mechanisms of Split-belt Treadmill Adaptation in People With Multiple Sclerosis
Official Title
The Neural Underpinnings and the Impact of Wearable Sensory Stimulation During Split-belt Treadmill Adaptation in People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
Collaborators
National Multiple Sclerosis Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
split-belt treadmill, adaptation, multiple sclerosis, functional near-infrared spectroscopy, cortical activation, gait asymmetry, locomotion, sensorimotor control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Split-belt Treadmill Training without TENS
Arm Type
Sham Comparator
Arm Description
During this arm, participants will perform split-belt treadmill training with sensory stimulation equipment outfitted but not active during all adaptation sessions.
Arm Title
Split-belt Treadmill Training with TENS
Arm Type
Experimental
Arm Description
During this arm, participants will perform split-belt treadmill training with active sensory stimulation occuring simultaneously during all adaptation sessions.
Intervention Type
Behavioral
Intervention Name(s)
Split-belt Treadmill
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Cortical Hemodynamics
Description
The changes of oxygenated hemoglobin in the cortex, a proxy for neuronal activity.
Time Frame
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)
Title
Change in Step Length Asymmetry
Description
The difference in the distance covered by each step, a common measure of gait asymmetry, measured using three-dimensional motion capture and force plates.
Time Frame
Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)
Title
Change in Phase Coordination Index
Description
The accuracy and consistency of step time compared to stride time, measured using three-dimensional motion capture and force plates.
Time Frame
Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)
Secondary Outcome Measure Information:
Title
Change in Limb Excursion Asymmetry
Description
The anterior-posterior distance traveled by the limb from toe-off to ipsilateral heel strike, measured using three-dimensional motion capture and force plates.
Time Frame
Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)
Title
Change in Double Support Percent
Description
The percentage of time spent with both feet on the ground during walking, measured using three-dimensional motion capture and force plates.
Time Frame
Baseline session 1 (day 1), post-training session 1 (day 1), baseline session 2 (day 14), and post-training session 2 (day 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brett W Fling, Ph.D.
Phone
(970) 491-3451
Email
brett.fling@colostate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew C Hagen
Phone
(970) 491-6160
Email
andrew.hagen@colostate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett W Fling, Ph.D.
Organizational Affiliation
Colorado State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sensorimotor Neuroimaging Laboratory
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brett W Fling
Phone
970-491-3451
Email
brett.fling@colostate.edu
First Name & Middle Initial & Last Name & Degree
Brett W Fling, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will not publicly available due to participant privacy.

Learn more about this trial

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

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