- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217047
Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury (CURE-SCI)
January 7, 2021 updated by: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
CURE-SCI. Clinical Utilization of CNS Growth Factor Release in Response to Electrical Stimulation Following Spinal Cord Injury.
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Kennedy Krieger Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A
For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.
|
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 Names:
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 Names:
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 Names:
|
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.
|
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 Names:
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 Names:
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 Names:
|
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.
|
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 Names:
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 Names:
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 Names:
|
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.
|
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 Names:
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 Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CSF Brain Derived Neurotrophic Factor (BDNF) Level
Time Frame: Baseline
|
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
|
Baseline
|
CSF Brain Derived Neurotrophic Factor (BDNF) Level
Time Frame: At 3 weeks
|
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
|
At 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Time Frame: Baseline
|
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.
|
Baseline
|
Mood Assessment
Time Frame: 3 weeks
|
We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7" (http://www.mood247.com).
|
3 weeks
|
CSF Growth Factor Quantification
Time Frame: Baseline
|
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.
|
Baseline
|
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Time Frame: Baseline
|
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
|
Baseline
|
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Time Frame: At 3 weeks
|
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.
|
At 3 weeks
|
CSF Growth Factor Quantification
Time Frame: At 3 weeks
|
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.
|
At 3 weeks
|
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Time Frame: At 3 weeks
|
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
|
At 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Becker, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
September 2, 2010
First Submitted That Met QC Criteria
October 7, 2010
First Posted (ESTIMATE)
October 8, 2010
Study Record Updates
Last Update Posted (ACTUAL)
January 27, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00036348
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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