Not provided
Not provided
Not provided
Not provided
Lack of funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 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. |
|
| 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. |
|
| 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 Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods. | Baseline |
| CSF Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods. | At 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mood Assessment | We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7" (http://www.mood247.com). | 3 weeks |
| Spasticity Testing Using the Modified Ashworth Scale (MAS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Becker, M.D. | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
One patient was not assigned to any intervention due to screen failure.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). 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. |
| 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). 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. |
| 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). 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants assigned randomly into one of these groups. No one assigned in group D.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). 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. |
| 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 |
| 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 Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | Posted | Baseline |
|
Baseline (week 0) to Final (week 3)
Not provided
Not provided
| 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 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). 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Becker, M.D. | Kennedy Krieger Institute | 888-923-9222 | dbecke13@jhu.edu |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
| 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). |
|
|
| 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. |
|
|
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 |
| CSF Growth Factor Quantification | 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 | 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. | At 3 weeks |
| CSF Growth Factor Quantification | 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 | We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods. | At 3 weeks |
| 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). 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. |
| 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). 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. |
| 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). 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). 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. |
| 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). 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. |
| 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). 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. |
|
| Primary | CSF Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | Posted | At 3 weeks |
|
|
| Secondary | Mood Assessment | We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7" (http://www.mood247.com). | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from 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. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | Posted | Baseline |
|
|
| Secondary | CSF Growth Factor Quantification | 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. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | Posted | Baseline |
|
|
| Secondary | Serum Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | 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. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | Posted | At 3 weeks |
|
|
| Secondary | CSF Growth Factor Quantification | 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. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | Posted | At 3 weeks |
|
|
| Secondary | Serum Brain Derived Neurotrophic Factor (BDNF) Level | We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods. | Investigator has resigned and due to the lack of funding data were not analyzed. No results were generated from this assessment. | Posted | At 3 weeks |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| 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). 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| 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). 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. | 0 | 3 | 0 | 3 | 0 | 3 |
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |