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Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury (CURE-SCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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:
NCT01217047
First received: September 2, 2010
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

This research is being done to study the effect of Functional Electrical Stimulation (FES) cycling on factors in blood and spinal cord in people with spinal cord injury (SCI).


Condition Intervention Phase
Spinal Cord Injury
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: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CURE-SCI. Clinical Utilization of CNS Growth Factor Release in Response to Electrical Stimulation Following Spinal Cord Injury.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • CSF brain derived neurotrophic factor (BDNF) level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.

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


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 quantify levels of neurotrophin-3 (NT3), neurotrophin-4 (NT4), glial cell line-derived neurotrophic factor (GDNF), ciliary neurotrophic factor (CNTF), and nerve growth factor (NGF) in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.

  • 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: At 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: At 3 weeks ] [ Designated as safety issue: No ]
    We will quantify levels of neurotrophin-3 (NT3), neurotrophin-4 (NT4), glial cell line-derived neurotrophic factor (GDNF), ciliary neurotrophic factor (CNTF), and nerve growth factor (NGF) in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.

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


Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (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. Although this device has been cleared by the Food and Drug Administration (FDA) for use by individuals with spinal cord injury, we are trying to find out the best way to use it in order to obtain the greatest benefits in an attempt to improve functional recovery.

  Eligibility

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

Inclusion Criteria:

  • History of traumatic spinal cord injury sustained at least 6 months prior
  • Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
  • No use of functional electrical stimulation within 3 months
  • Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
  • Legally able to make own health care decisions

Exclusion Criteria:

  • Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
  • Uncontrolled hypertension (resting systolic blood pressure (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 (2) 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: NCT01217047

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@kennedykrieger.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

No publications provided

Responsible Party: Daniel Becker, Assistant Professor of Neurology Johns Hopkins School of Medicine, Head of Pediatric Restoration Therapy The International Center for Spinal Cord Injury Kennedy Krieger Institute, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01217047     History of Changes
Other Study ID Numbers: NA_00036348
Study First Received: September 2, 2010
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Spinal cord injury
Functional electrical stimulation
Rehabilitation
Growth factors
Cytokines

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014