Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

Evaluating the Effects of Functional Electrical Stimulation on Ambulation in Individuals With Secondary Progressive Multiple Sclerosis

Secondary progressive multiple sclerosis (SPMS) is a subtype of multiple sclerosis (MS) for which there are no existing therapies that alter the disease course. This research will utilize cutting edge functional electrical stimulation (FES) cycling technology with the goal of improving walking in individuals with SPMS. The investigators hypothesize that FES cycling will improve walking in subjects with SPMS.

Study Overview

• Status: Completed
• Conditions: Secondary Progressive Multiple Sclerosis
• Intervention / Treatment: Behavioral: Active cycling; Behavioral: Passive cycling

Detailed Description

Individuals with secondary progressive multiple sclerosis (SPMS) experience significant impairments in ambulation leading to use of canes, walkers, and ultimately wheelchairs. Treatment attempts for progressive MS have been disappointing. No therapeutic intervention has been shown to modulate disability in patients with SPMS. FES cycling has been shown to have multiple primary medical benefits including: increased muscle mass, improvements in bone density, enhanced cardiovascular function, improved bowel function, decreased spasticity and reductions in bladder infection rate. More importantly FES may modulate the inflammatory central nervous system (CNS) environment in progressive MS. The investigators are proposing a novel, and easy to implement intervention strategy of FES cycling to help improve gait function in individuals with SPMS. A successful outcome on a larger SPMS population would have significant impact towards changing MS clinical care. FES is easily transferable to clinical practice and could potentially ameliorate other complications associated with SPMS such as spasticity, mood and fatigue reducing the burden of health care cost. In addition, the investigators will gain a better understanding of the mechanisms underlying these changes that could be used to design new therapeutic strategies.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins / Kennedy Krieger Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• clinical diagnosis of secondary progressive multiple sclerosis
• males and females between the ages of 18 and 65 years
• Expanded disability status scale score between 5.0 and 7.0
• Able to consent to participate in study and are willing to undergo a lumbar puncture and blood draws
• If on on Ampyra or anti-spasticity agent, must be on stable dose for 1 month prior to screening
• No functional electrical stimulation use within 4 weeks
• Participants must be medically stable with no recent (1 month or less) inpatient admission for acute medical or surgical issues

Exclusion Criteria:

• Uncontrolled hypertension or other significant cardiovascular disease as determined by investigator
• History of epileptic seizures
• Subjects who have a pacemaker
• Relapse within thirty days prior to screening visit
• Pregnancy
• Subjects having a Stage 2 or greater sacral decubitus ulcer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active cycling; Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal.	Behavioral: Active cycling; The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to actively pedal while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.; Other Names: endurance training; cycling
Sham Comparator: Passive cycling; Individuals will receive active functional electrical stimulation (FES) while on the stationary bike and instructed to relax their legs, allowing the FES to move their legs on the stationary bike.	Behavioral: Passive cycling; The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to sit passively on the stationary bile while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.; Other Names: letting the functional electrical stimulation move the legs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in timed 25 foot walk from baseline to end of training	Here we will assess whether a subjects walking speed is improved following active cycling with functional electrical stimulation. Our prediction is that individuals will improve in their walking function following seated active cycling with functional electrical stimulation.	Participants are assessed at baseline (visit 1), one-month (visit 2), two-months (visit 3), three-months (visit 4), end of study (visit 5)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Investigators: Principal Investigator: Scott Newsome, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: SPMS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplastic Processes; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Neoplasm Metastasis
• Other Study ID Numbers: NA_00069253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO