Trial Outcomes & Findings for Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury (NCT NCT03854214)

NCT ID: NCT03854214

Last Updated: 2025-03-10

Results Overview

Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Baseline

Results posted on

2025-03-10

Participant Flow

Participant milestones

Participant milestones
Measure
Functional Electric Stimulation Cycling
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 revolutions per minute (RPM). Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Overall Study
STARTED
9
5
Overall Study
COMPLETED
9
5
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of Brain Functional MRI as an Early Biomarker of Recovery in Individuals With Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Functional Electric Stimulation Cycling
n=9 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=5 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Total
n=14 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=99 Participants
5 Participants
n=107 Participants
12 Participants
n=206 Participants
Age, Categorical
>=65 years
2 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants
4 Participants
n=107 Participants
12 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=99 Participants
1 Participants
n=107 Participants
4 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
6 Participants
n=99 Participants
4 Participants
n=107 Participants
10 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
6 Participants
n=99 Participants
3 Participants
n=107 Participants
9 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Region of Enrollment
United States
9 participants
n=99 Participants
5 participants
n=107 Participants
14 participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline

Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=9 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=5 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
59.5 score on a scale
Standard Deviation 11.34
60.4 score on a scale
Standard Deviation 14.68

PRIMARY outcome

Timeframe: 2 weeks

Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=7 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=5 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
62.2 score on a scale
Standard Deviation 15.09
61 score on a scale
Standard Deviation 15.14

PRIMARY outcome

Timeframe: 4 weeks

Developed by the American Spinal Injury Association (ASIA), the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) provides an overall assessment of motor and sensory function following spinal cord injury. For this study, a single composite ISNCSCI score is reported, which ranges from 0 (indicating the worst overall function) to 324 (indicating normal overall function). The data table presents this composite score as the sole outcome measure for each Arm/Group.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=7 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=4 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
International Standard of Neurological Classification for Spinal Cord Injury (ISNCSCI) Score
64.4 score on a scale
Standard Deviation 13.49
63.5 score on a scale
Standard Deviation 14.12

PRIMARY outcome

Timeframe: Baseline

Resting state functional magnetic resonance imaging (RsfMRI) functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=9 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=5 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Resting State fMRI Functional Connectivity
0.556 Unitless (Pearson's correlation coeff)
Standard Deviation 0.152
0.587 Unitless (Pearson's correlation coeff)
Standard Deviation 0.152

PRIMARY outcome

Timeframe: 2 weeks

RsfMRI functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=7 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=5 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Resting State fMRI Functional Connectivity
0.496 Unitless (Pearson's correlation coeff)
Standard Deviation 0.119
0.493 Unitless (Pearson's correlation coeff)
Standard Deviation 0.143

PRIMARY outcome

Timeframe: 4 weeks

RsfMRI functional connectivity is defined as the temporal dependency of neuronal activation patterns (represented by the blood oxygenation level dependent (BOLD) signal time courses as measured using rsfMRI) of anatomically separated brain regions. There are number of methodologies one can use to characterize the degree and type of rsfMRI functional connectivity. One example is between-network-connectivity (BNC), which is defined as the degree of correlation between two time courses obtained from a pair of brain regions. Summary statistics of BNC (e.g., mean, variance), as well as the dynamic properties of BNC (e.g., dynamic functional connectivity) can be used to further summarize the characteristics of the functional connectivity in SCI population. Note that the BNC values reported in the Outcome Measure data table represent "Pearson's Correlation Coefficient" and not z-transformed Pearson's Correlation Coefficients.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=7 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=4 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Resting State fMRI Functional Connectivity
0.533 Unitless (Pearson's correlation coeff)
Standard Deviation 0.120
0.496 Unitless (Pearson's correlation coeff)
Standard Deviation 0.096

PRIMARY outcome

Timeframe: Baseline

Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel. RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=9 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=5 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
0.491 Unitless coefficient (dimensionless)
Standard Deviation 0.0880
0.4670 Unitless coefficient (dimensionless)
Standard Deviation 0.0914

PRIMARY outcome

Timeframe: 2 weeks

Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel. RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=7 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=5 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
0.813 Unitless coefficient (dimensionless)
Standard Deviation 0.119
0.484 Unitless coefficient (dimensionless)
Standard Deviation 0.0737

PRIMARY outcome

Timeframe: 4 weeks

Resting-state functional connectivity can also identify functionally homogeneous brain regions, or "parcels." By examining each parcel's properties, such as the center of mass and recruitment coefficient value, we can gain insights into the brain's functional reorganization. Given its importance in the SCI population, we focused on the sensorimotor network (SMN) parcel. RsfMRI data were collected and preprocessed. The brain data was then parcellated into 200 parcels. Next, a multi-layer community detection algorithm was applied to identify cohesive subnetworks over time, and the SMN Recruitment Coefficient was calculated - which is a dimensionless metric that quantifies how strongly the SMN parcels cohere, or preferentially connect, with one another compared to parcels in other networks. Higher values suggest a more internally cohesive SMN, indicating stronger functional segregation and potentially more intact sensorimotor function.

Outcome measures

Outcome measures
Measure
Functional Electric Stimulation Cycling
n=7 Participants
The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc) with stimulation on. Functional Electric Stimulation cycling: The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
Passive Cycling
n=4 Participants
The passive cycling group will use the same RT300 ergometer with stimulation off. Passive cycling: The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
Resting-State fMRI Brain Parcels Outcome Measure: Sensorimotor Network (SMN) Recruitment Coefficient
0.713 Unitless coefficient (dimensionless)
Standard Deviation 0.146
0.581 Unitless coefficient (dimensionless)
Standard Deviation 0.102

Adverse Events

Functional Electric Stimulation Cycling

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Passive Cycling

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ann S. Choe, Ph.D.

Kennedy Krieger Institute

Phone: 443-923-9500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place