Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

NCT ID: NCT01647321

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2019-10-31

Brief Summary

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.

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.

Conditions

Secondary Progressive Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active cycling

Individuals will receive functional electrical stimulation while on the stationary bike and instructed to actively pedal.

Group Type: ACTIVE_COMPARATOR

Active cycling

Intervention Type: BEHAVIORAL

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.

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.

Group Type: SHAM_COMPARATOR

Passive cycling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

cycling; endurance training; letting the functional electrical stimulation move the legs

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Newsome, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins / Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00069253

Identifier Type: -

Identifier Source: org_study_id