Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Neuromuscular Electrical Stimulation and Mobility in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152085
• Other study ID #: 13-0720
• Secondary ID: R03HD079508
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2021
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the capacity of a 6-week treatment with neuromuscular electrical stimulation to improve walking in individuals whose mobility has been compromised by multiple sclerosis.

Description:

Participants will be randomly assigned to one of two study arms. Those in one arm will receive a treatment with narrow stimulus pulses (0.4 ms) and those in the other arm will receive wide stimulus pulses (1 ms). The electrical stimulation will be delivered with a Vectra Genisys System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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

• Difficulties with walking

• On stable doses of Ampyra, provigil, or other symptomatic-treating medications

• No systemic steroids within the last 30 days

• Not currently exercising more than 2x/wk

• Able to arrange own transportation to and from the laboratories

• Provide informed consent, including willingness to be randomly assigned to one of the two groups

Exclusion Criteria:

• Documented MS-related relapse in the last 3 months

• Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), other neurological disorders, or pregnancy

• Poorly controlled diabetes mellitus or hypertension

• History of seizure disorders

• Alcohol dependence or abuse (=2 drinks/day), or present history (last 6 months) of drug abuse

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Narrow pulse
Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
• Wide pulse
Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.

Locations

Country	Name	City	State
United States	University of Colorado	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Endurance	Distance walked in 6 min	Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Primary	Modified Fatigue Impact Scale	MFIS scores range from 0 to 84 and higher numbers indicating worse fatigue.	Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).
Secondary	Maximal Walking Speed	The time it takes to walk 25 ft	Change from before to after 18 treatment sessions administered over a 6-week period (3 sessions/week).