Back to resultsCNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies (FIRST-STIM)
Primary Purpose
Inflammatory Myelopathies
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FES Cycling
Cycling without FES
Lumbar puncture
Mood assessment
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Myelopathies focused on measuring TM, MS, Spinal Cord Injury, Functional electrical stimulation, Rehabilitation, Growth factors, Cytokines
Eligibility 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 New York Heart Association (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 cerebrospinal fluid (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
Sites / Locations
- International Neurorehabilitation Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A
Group B
Group C
Group D
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
CSF BDNF Levels in Subjects With Inflammatory Myelopathy
We will measure cerebrospinal fluid (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
We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7".
Spasticity Testing Using the Modified Ashworth Scale (MAS)
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
We will measure CSF concentrations of interleukin (IL)-6, IL-17, tumor necrosis factor (TNF)-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods
Spasticity Testing Using the Modified Ashworth Scale (MAS)
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
We will measure CSF concentrations of IL-6, IL-17, TNF-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Full Information
NCT ID
NCT01440452
First Posted
September 22, 2011
Last Updated
June 30, 2020
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01440452
Brief Title
CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
Acronym
FIRST-STIM
Official Title
CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Myelopathies
Keywords
TM, MS, Spinal Cord Injury, Functional electrical stimulation, Rehabilitation, Growth factors, Cytokines
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C
Arm Type
Experimental
Arm Description
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.
Arm Title
Group D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FES Cycling
Other Intervention Name(s)
RT300-SL, from Restorative Therapies, INC.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cycling without FES
Other Intervention Name(s)
RT300-SL, from Restorative Therapies, INC.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lumbar puncture
Other Intervention Name(s)
Spinal Tap
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mood assessment
Other Intervention Name(s)
Mood24/7
Intervention Description
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 Outcome Measure Information:
Title
CSF BDNF Levels in Subjects With Inflammatory Myelopathy
Description
We will measure cerebrospinal fluid (CSF) concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Mood Assessment
Description
We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7".
Time Frame
3 weeks
Title
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Description
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.
Time Frame
Baseline
Title
CSF Growth Factor Quantification
Description
We will measure CSF concentrations of interleukin (IL)-6, IL-17, tumor necrosis factor (TNF)-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
Time Frame
Baseline
Title
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Description
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods
Time Frame
Baseline
Title
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Description
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
Time Frame
3 weeks
Title
CSF Growth Factor Quantification
Description
We will measure CSF concentrations of IL-6, IL-17, TNF-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.
Time Frame
3 weeks
Title
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Description
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 New York Heart Association (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 cerebrospinal fluid (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Becker, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Neurorehabilitation Institute
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mood247.com
Description
Related Info
Learn more about this trial
CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
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