Inflammatory MyelopathiesFIRST-STIMNCT01440452
CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
A study testing FES Cycling, Cycling without FES and Lumbar puncture in people with Inflammatory Myelopathies, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Myelopathies
- What is being tested?
- FES Cycling, Cycling without FES and Lumbar puncture
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
International Neurorehabilitation Institute
Lutherville, Maryland, 21093
About this study
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.
Read the 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.
- Conditions
- Inflammatory Myelopathies
- Being tested
- FES Cycling, Cycling without FES, Lumbar puncture, Mood assessment
- Keywords
- TM, MS, Spinal Cord Injury, Functional electrical stimulation, Rehabilitation, Growth factors, Cytokines
- Medical subject headings
- Myelitis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES CyclingDevice
Also called RT300-SL, from Restorative Therapies, INC.
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.
Cycling without FESDevice
Also called RT300-SL, from Restorative Therapies, INC.
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.
Lumbar punctureProcedure or surgery
Also called Spinal Tap
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).
Mood assessmentBehavioural
Also called Mood24/7
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Device: FES Cycling; Procedure: Lumbar puncture; Behavioral: Mood assessment |
| Group B | Experimental | 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. Receives: Device: FES Cycling; Procedure: Lumbar puncture; Behavioral: Mood assessment |
| Group C | Experimental | 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. Receives: Device: FES Cycling; Procedure: Lumbar puncture; Behavioral: Mood assessment |
| Group D | Experimental | 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. Receives: Device: Cycling without FES; Procedure: Lumbar puncture; Behavioral: Mood assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (7)
Mood Assessment
We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7".
Measured: 3 weeks
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.
Measured: Baseline
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.
Measured: Baseline
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods
Measured: Baseline
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
Measured: 3 weeks
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.
Measured: 3 weeks
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory MyelopathiesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Becker, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440452
- Sponsor's protocol ID
- NA_00041441
- Acronym
- FIRST-STIM
- Status last verified
- Jun 2020
- First submitted
- 22 Sep 2011
- Last updated
- 17 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies
- ClinicalTrials.gov ID
- NCT01440452
- Acronym / sponsor ID
- FIRST-STIM / NA_00041441
- Conditions
- Inflammatory Myelopathies
- Keywords
- TM, MS, Spinal Cord Injury, Functional electrical stimulation, Rehabilitation, Growth factors, Cytokines
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 26 Sep 2011 (estimated)
- Results
- Posted 17 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: FES Cycling, Procedure: Lumbar puncture, Behavioral: Mood assessmentFor 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. |
| Group B | Experimental | Device: FES Cycling, Procedure: Lumbar puncture, Behavioral: Mood assessmentFor 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. |
| Group C | Experimental | Device: FES Cycling, Procedure: Lumbar puncture, Behavioral: Mood assessmentFor 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. |
| Group D | Experimental | Device: Cycling without FES, Procedure: Lumbar puncture, Behavioral: Mood assessmentFor 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES CyclingAlso: RT300-SL, from Restorative Therapies, INC.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. | Device | Group A, Group B, Group C |
| Cycling without FESAlso: RT300-SL, from Restorative Therapies, INC.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. | Device | Group D |
| Lumbar punctureAlso: Spinal TapThe 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). | Procedure or surgery | Group A, Group B, Group C, Group D |
| Mood assessmentAlso: Mood24/7If 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. | Behavioural | Group A, Group B, Group C, Group D |
Primary outcome
CSF BDNF Levels in Subjects With Inflammatory Myelopathy
Time frame: Baseline
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.
7 secondary outcomes
Mood Assessment
Time frame: 3 weeks
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Time frame: Baseline
CSF Growth Factor Quantification
Time frame: Baseline
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Time frame: Baseline
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Time frame: 3 weeks
CSF Growth Factor Quantification
Time frame: 3 weeks
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Becker, M.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES Cycling, Cycling without FES and Lumbar puncture in people with Inflammatory Myelopathies, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF BDNF Levels in Subjects With Inflammatory Myelopathy (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.