Functional Electrical Stimulation for Individuals With Secondary Progressive Multiple Sclerosis

NCT01647321 | Completed

• 1 other identifier: NA_00069253
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Progressive Multiple Sclerosis

Keywords

SPMS

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Active cycling

ACTIVE COMPARATOR

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

Behavioral: Active cycling

Passive cycling

SHAM COMPARATOR

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

Interventions

Active cycling 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.

Also known as: cycling, endurance training

Active cycling

Passive cycling 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.

Also known as: letting the functional electrical stimulation move the legs

Passive cycling

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: collaborator

Study Sites (1)

Johns Hopkins / Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Scott Newsome, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)