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Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury (CURE-SCI)

Primary Purpose

Spinal Cord Injury

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FES Cycling
Cycling without FES
Lumbar puncture
Mood assessment
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord injury, Functional electrical stimulation, Rehabilitation, Growth factors, Cytokines

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of traumatic spinal cord injury sustained at least 6 months prior
  • Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A
  • No use of functional electrical stimulation within 3 months
  • Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
  • Legally able to make own health care decisions

Exclusion Criteria:

  • Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability
  • Uncontrolled hypertension (resting systolic blood pressure (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 (2) CSF examinations (lumbar punctures)
  • Presence of cardiac pacemaker and/or defibrillator
  • Presence of cancer
  • History of epileptic seizures
  • Subjects having a Stage 2 or greater sacral decubitus ulcer
  • Women who are pregnant
  • Active drug or alcohol use or dependence

Sites / Locations

  • Kennedy Krieger Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.

For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.

For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.

For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.

Outcomes

Primary Outcome Measures

CSF Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
CSF Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.

Secondary Outcome Measures

Mood Assessment
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)
The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions.
CSF Growth Factor Quantification
We will 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.
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Spasticity Testing Using the Modified Ashworth Scale (MAS)
The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions.
CSF Growth Factor Quantification
We will 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.
Serum Brain Derived Neurotrophic Factor (BDNF) Level
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.

Full Information

First Posted
September 2, 2010
Last Updated
January 7, 2021
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01217047
Brief Title
Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury
Acronym
CURE-SCI
Official Title
CURE-SCI. Clinical Utilization of CNS Growth Factor Release in Response to Electrical Stimulation Following Spinal Cord Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal cord injury, Functional electrical stimulation, Rehabilitation, Growth factors, Cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
For 3 weeks, you will need to come to the ICSCI one (1) time per week during which you will perform FES cycling for 1 hour each.
Arm Title
Group B
Arm Type
Experimental
Arm Description
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each.
Arm Title
Group C
Arm Type
Experimental
Arm Description
For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each.
Arm Title
Group D
Arm Type
Experimental
Arm Description
For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each.
Intervention Type
Device
Intervention Name(s)
FES Cycling
Other Intervention Name(s)
RT300-SL, from Restorative Therapies, INC.
Intervention Description
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.
Intervention Type
Device
Intervention Name(s)
Cycling without FES
Other Intervention Name(s)
RT300-SL, from Restorative Therapies, INC.
Intervention Description
You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.
Intervention Type
Procedure
Intervention Name(s)
Lumbar puncture
Other Intervention Name(s)
Spinal tap
Intervention Description
The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
Intervention Type
Behavioral
Intervention Name(s)
Mood assessment
Other Intervention Name(s)
Mood24/7
Intervention Description
If you do not already have an account, you will be signed up with "Mood24/7" (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period.
Primary Outcome Measure Information:
Title
CSF Brain Derived Neurotrophic Factor (BDNF) Level
Description
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
Time Frame
Baseline
Title
CSF Brain Derived Neurotrophic Factor (BDNF) Level
Description
We will quantify levels of BDNF in the cerebrospinal fluid (CSF) using immunohistochemical quantification methods.
Time Frame
At 3 weeks
Secondary Outcome Measure Information:
Title
Mood Assessment
Description
We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7" (http://www.mood247.com).
Time Frame
3 weeks
Title
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Description
The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions.
Time Frame
Baseline
Title
CSF Growth Factor Quantification
Description
We will 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.
Time Frame
Baseline
Title
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Description
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Time Frame
Baseline
Title
Spasticity Testing Using the Modified Ashworth Scale (MAS)
Description
The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions.
Time Frame
At 3 weeks
Title
CSF Growth Factor Quantification
Description
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.
Time Frame
At 3 weeks
Title
Serum Brain Derived Neurotrophic Factor (BDNF) Level
Description
We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.
Time Frame
At 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of traumatic spinal cord injury sustained at least 6 months prior Complete spinal cord injury at any level American Spinal Injury Association (ASIA) impairment scale A No use of functional electrical stimulation within 3 months Medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues Legally able to make own health care decisions Exclusion Criteria: Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke, history of arrhythmia with hemodynamic instability Uncontrolled hypertension (resting systolic blood pressure (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 (2) CSF examinations (lumbar punctures) Presence of cardiac pacemaker and/or defibrillator Presence of cancer History of epileptic seizures Subjects having a Stage 2 or greater sacral decubitus ulcer Women who are pregnant Active drug or alcohol use or dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Becker, M.D.
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

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Study on Functional Electrical Stimulation (FES) Cycling Following Spinal Cord Injury

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