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CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies (FIRST-STIM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Information provided by (Responsible Party):
Daniel Becker, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01440452
First received: September 22, 2011
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Inflammatory Myelopathies
Device: FES Cycling
Device: Cycling without FES
Procedure: Lumbar puncture
Behavioral: Mood assessment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies

Resource links provided by NLM:


Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • CSF BDNF levels in subjects with inflammatory myelopathy [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    We will measure CSF concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.


Secondary Outcome Measures:
  • Mood assessment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7" (http://www.mood247.com).

  • Spasticity testing using the Modified Ashworth Scale (MAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions.

  • CSF growth factor quantification [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    We will measure CSF concentrations of IL-6, IL17, TNFα, IL-1ß, IL-23, and IL-12 in response to FES ergometry.

  • Serum brain derived neurotrophic factor (BDNF) level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods

  • Spasticity testing using the Modified Ashworth Scale (MAS) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions

  • CSF growth factor quantification [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    We will measure CSF concentrations of IL-6, IL17, TNFα, IL-1ß, IL-23, and IL-12 in response to FES ergometry.

  • Serum brain derived neurotrophic factor (BDNF) level [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.


Estimated Enrollment: 105
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
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.
Device: FES Cycling
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.
Other Name: RT300-SL, from Restorative Therapies, INC.
Procedure: Lumbar puncture
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).
Other Name: Spinal Tap
Behavioral: Mood assessment
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.
Other Name: Mood24/7
Experimental: Group B
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.
Device: FES Cycling
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.
Other Name: RT300-SL, from Restorative Therapies, INC.
Procedure: Lumbar puncture
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).
Other Name: Spinal Tap
Behavioral: Mood assessment
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.
Other Name: Mood24/7
Experimental: Group C
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.
Device: FES Cycling
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.
Other Name: RT300-SL, from Restorative Therapies, INC.
Procedure: Lumbar puncture
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).
Other Name: Spinal Tap
Behavioral: Mood assessment
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.
Other Name: Mood24/7
Experimental: Group D
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.
Device: Cycling without FES
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.
Other Name: RT300-SL, from Restorative Therapies, INC.
Procedure: Lumbar puncture
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).
Other Name: Spinal Tap
Behavioral: Mood assessment
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.
Other Name: Mood24/7

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440452

Contacts
Contact: Shannon M Inches 443-923-9235 Inches@kennedykrieger.org

Locations
United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Shannon M Inches    443-923-9235    Inches@kennedkrieger.org   
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
Principal Investigator: Daniel Becker, M.D. Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel Becker, Daniel Becker, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01440452     History of Changes
Other Study ID Numbers: NA_00041441
Study First Received: September 22, 2011
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
TM
MS
Spinal Cord Injury
Functional electrical stimulation
Rehabilitation
Growth factors
Cytokines

Additional relevant MeSH terms:
Bone Marrow Diseases
Myelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Hematologic Diseases
Nervous System Diseases
Spinal Cord Diseases
Virus Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014