Overview

This trial is active, not recruiting.

Condition inflammatory myelopathies
Treatments fes cycling, cycling without fes, lumbar puncture, mood assessment
Phase phase 2/phase 3
Sponsor Johns Hopkins University
Start date November 2010
End date December 2019
Trial size 35 participants
Trial identifier NCT01440452, NA_00041441

Summary

This research is being done to see how different amounts of Functional Electrical Stimulation (FES) affect cycling on factors in blood and spinal cord in people with spinal cord inflammation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform FES cycling for 1 hour each.
fes cycling RT300-SL, from Restorative Therapies, INC.
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.
lumbar puncture Spinal Tap
The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
mood assessment Mood24/7
If you do not already have an account, you will be signed up with "Mood24/7" (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period.
(Experimental)
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.
fes cycling RT300-SL, from Restorative Therapies, INC.
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.
lumbar puncture Spinal Tap
The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
mood assessment Mood24/7
If you do not already have an account, you will be signed up with "Mood24/7" (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period.
(Experimental)
For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.
fes cycling RT300-SL, from Restorative Therapies, INC.
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.
lumbar puncture Spinal Tap
The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
mood assessment Mood24/7
If you do not already have an account, you will be signed up with "Mood24/7" (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period.
(Experimental)
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.
cycling without fes RT300-SL, from Restorative Therapies, INC.
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.
lumbar puncture Spinal Tap
The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
mood assessment Mood24/7
If you do not already have an account, you will be signed up with "Mood24/7" (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period.

Primary Outcomes

Measure
CSF BDNF levels in subjects with inflammatory myelopathy
time frame: Baseline

Secondary Outcomes

Measure
Mood assessment
time frame: 3 weeks
Spasticity testing using the Modified Ashworth Scale (MAS)
time frame: Baseline
CSF growth factor quantification
time frame: Baseline
Serum brain derived neurotrophic factor (BDNF) level
time frame: Baseline
Spasticity testing using the Modified Ashworth Scale (MAS)
time frame: 3 weeks
CSF growth factor quantification
time frame: 3 weeks
Serum brain derived neurotrophic factor (BDNF) level
time frame: 3 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: Male, Female, age 18-65, all ethnic groups History of inflammatory myelopathy with onset at least 3 months prior No FES ergometer (i.e. RT300 or equivalent) use within 1 month Subject is medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues Subject is legally able to make own health care decisions Access to telephone with texting capabilities English language proficiency Exclusion Criteria: - Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability. Uncontrolled hypertension (resting systolic BP>160mmHg or diastolic BP >100mmHg consistently) Concurrent lower motor neuron disease such as peripheral neuropathy that would exclude lower extremity electrical excitability Unstable long bone fractures of the lower extremities Subjects who are unwilling to agree to two CSF examinations (lumbar punctures) Presence of cardiac pacemaker and/or defibrillator Presence of cancer History of epileptic seizures Subjects having a Stage 2 or greater sacral decubitus ulcer Women who are pregnant Active drug or alcohol use or dependence

Additional Information

Official title CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
Principal investigator Daniel Becker, M.D.
Description FES cycling is a method of applying low level electrical currents to the leg and buttock muscles to cause the weakened or paralyzed muscles to contract and produce a cycling motion of the legs. The FES cycling in this study will be done through a device called the RT300-SL Cycle Ergometer (RT300). Although this device has been cleared by the Food and Drug Administration (FDA) for use by individuals with neurological disorders, we are trying to find out the best way to use it in order to obtain the greatest results.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Johns Hopkins University.