Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy

Multiple Sclerosis Clinical Trial

Official title:

Improving Mobility and Reducing Fatigue in People With Multiple Sclerosis by Electrical Stimulation Therapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03684369
• Other study ID #: UColoradoBoulder2
• Status: Withdrawn
• Phase: N/A
• Start date: July 2020
• Est. completion date: June 2025

Study information

• Verified date: November 2020
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the clinical trial is to quantify the capacity of a translatable protocol of electrical nerve stimulation (TENS) to improve walking performance and self-reported disabilities of persons with MS. The hypothesis is that activation of sensory nerve fibers with augmented TENS promotes recovery of sensorimotor function and improves the disability status of individuals with MS. The rationale for the proposed clinical trial is that the approach provides a low-cost therapeutic strategy for persons with MS to manage walking limitations and fatigue.

Description:

The study will involve a randomized, double-blind, controlled trial. Randomization will be accomplished by recruiting two individuals with a similar level of disability at a time and flipping a coin (two persons present) to determine the group assignment (A or B) of the person who contacted the investigators first. The participants and outcome assessors will be blinded to group assignment. Both groups will receive the treatment (real or sham) during the first 4 weeks (3 sessions/week)and then there will be an 8-week follow-up period. Participants will be evaluated at weeks 0, 4, 8, and 12.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Able to read, write, and speak English to ensure safe participation in the project

• Clinical diagnosis of multiple sclerosis

• Mild-to-moderate level of disability

• On stable doses of symptom-treating medications

• No MS exacerbations within the last 30 day

• Healthy enough to complete the protocol as indicated by the absence of a medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in tests that involve electrical nerve stimulation (e.g., not implanted devices or internal metal)

• Able to arrange own transportation to Boulder campus

Exclusion Criteria:

• Documented MS-related relapse within the last 30 days

• Medical diagnosis or condition that is considered to be a contraindication to participating in the intervention, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than basal cell cancer), other neurological disorders, or pregnancy.

• Vestibular disorder

• Musculoskeletal disorder

• History of seizure disorders

• >2 alcoholic drinks/day,or present history (last 6 months) of drug abuse

• Spasticity that requires the individual to change an activity more than once a week

• Skin disease or sensation problems in the legs or hands that influence some activities more than once a week

• Claustrophobia

• Metallic implants

• Inability to attend treatment sessions 3 days per week for 6 weeks

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Transcutaneous electrical nerve stimulation
Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Boulder	Colorado State University, University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gait Speed	Time to walk 25 ft as quickly as possible	Change from baseline at weeks 4, 8, and 12.
Primary	Change in Walking Endurance	Distance walked in 6 min when walking at a brisk pace	Change from baseline at weeks 4, 8, and 12
Primary	Change in Dynamic Balance	Score achieved on the four components of the 14-item Mini-Balance Evaluation Systems Test (Mini-BESTest). The maximum score for each subscale are: anticipatory = 6, reactive postural control = 6, sensory orientation = 6, dynamic gait = 10. The subscales are added to provide a total score with a maximum of 28.	Change from baseline at weeks 4, 8, and 12
Primary	Change in Patient Determined Disease Steps	A questionnaire with a self-assessment scale of disease status. The scores range from 0 = normal to 8 = bedridden.	Change from baseline at weeks 4, 8, and 12
Primary	Change in Modified Fatigue Impact Scale	A questionnaire that assesses the impact of fatigue experienced by persons with MS. Each of the 21 items is rated from 0 = Never to 5 = Almost always. The maximum total score = 105	Change from baseline at weeks 4, 8, and 12.
Primary	Change in MS Walking Scale-12	A 12-item, patient-rated measure of how much MS compromises walking ability. Each item is rated from 1 = Not at all to 5 = extremely. The maximum total score = 60.	Change from baseline at weeks 4, 8, and 12.
Secondary	Change in Romberg Quotient	Ratio of the total sway area when standing with the eyes closed relative to that when the eyes are open. The test will be performed while standing on a firm surface and a foam surface.	Change from baseline at weeks 4, 8, and 12.
Secondary	Change Conditioned H-reflex Amplitude	Comparison of the percent reduction in the amplitude of the conditioned H-reflex amplitude in soleus while seated, standing with eyes open, and standing with eyes closed.	Change from baseline at weeks 4, 8, and 12.
Secondary	Change in Proprioception Tract	Change in MRI signal intensity in corticospinal tract	Change from baseline at weeks 4, 8, and 12.
Secondary	Change in Muscle Synergy Number	Non-negative matrix factorization will be used to identify the number of muscle synergies when subjects walk on a treadmill.	Change from baseline at weeks 4, 8, and 12
Secondary	Change in Force Steadiness	The coefficient of variation for force when subjects perform steady, submaximal contractions.	Change from baseline at weeks 4, 8, and 12.
Secondary	Change in Muscle Synergy TIming	The timing of the muscle synergies when subjects walk on a treadmill.	Change from baseline at weeks 4, 8, and 12.
Secondary	Change in Discharge characteristics	The mean and coefficient of variation for the times between action potentials during steady isometric contractions.	Change from baseline at weeks 4, 8, and 12.