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.
Verified February 2013 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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
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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
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:
|
Spinal Cord Diseases Bone Marrow Diseases Myelitis Hematologic Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Viral Diseases |
Virus Diseases Central Nervous System Infections Mitogens Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013