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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES Cycling | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mood Assessment | We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7". | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Becker, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Neurorehabilitation Institute | Lutherville | Maryland | 21093 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 functional electrical stimulation (FES) cycling for 1 hour each. 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. 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2016 |
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| Cycling without FES | Device | 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. |
|
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| Lumbar puncture | Procedure | 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). |
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| Mood assessment | Behavioral | 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. |
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| 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. | Baseline |
| Serum Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods | 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 | 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. | 3 weeks |
| Serum Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods. | 3 weeks |
| FG001 | 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. 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. 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). |
| FG002 | 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. 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. 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). |
| FG003 | 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. 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. 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). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. 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). |
| BG001 | 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. 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. 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). |
| BG002 | 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. 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. 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). |
| BG003 | 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. 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. 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). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | CSF samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure. | Posted | Baseline |
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| ||||||||||||||||||||||||||||
| Secondary | Mood Assessment | We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7". | No data was collected for this assessment. | Posted | 3 weeks |
| |||||||||||||||||||||||||||||
| Secondary | 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. | No data was collected for this assessment. | Posted | Baseline |
| |||||||||||||||||||||||||||||
| Secondary | 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. | CSF samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure. | Posted | Baseline |
| |||||||||||||||||||||||||||||
| Secondary | Serum Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods | Blood samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure. | Posted | Baseline |
| |||||||||||||||||||||||||||||
| Secondary | 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 | No data was collected for this assessment. | Posted | 3 weeks |
| |||||||||||||||||||||||||||||
| Secondary | 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. | CSF samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure. | Posted | 3 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Serum Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods. | Blood samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure. | Posted | 3 weeks |
|
Adverse event data was collected for the study intervention period of 3 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. 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). | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | 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. 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. 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). | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | 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. 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. 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). | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | 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. 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. 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). | 0 | 4 | 0 | 4 | 0 | 4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Becker | Johns Hopkins Hospital | 4108284629 | db@inirehab.com |
| Jun 25, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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|
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| OG002 | 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. 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. 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). |
| OG003 | 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. 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. 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). |
|
| OG002 | 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. 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. 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). |
| OG003 | 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. 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. 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). |
|
| OG002 | 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. 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. 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). |
| OG003 | 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. 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. 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). |
|
| OG002 | 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. 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. 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). |
| OG003 | 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. 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. 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). |
|
| OG002 | 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. 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. 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). |
| OG003 | 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. 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. 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). |
|
| OG002 | 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. 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. 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). |
| OG003 | 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. 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. 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). |
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| OG002 | 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. 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. 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). |
| OG003 | 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. 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. 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). |
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