Stroke
Conditions
Keywords
aneurysm, transient ischemic attack
Brief summary
The purpose of this research is to determine if functional muscle stimulation, directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect to be on study for approximately 4 months.
Detailed description
Ongoing research (NCT02098265) suggests that noninvasive EEG driven Brain Computer Interface (BCI) systems hold the potential for facilitating recovery in the chronic phase after stroke by synchronizing central or brain activity with peripheral movements and thereby harnessing brain plasticity. The specific aims of this study are: Aim 1: To investigate the efficacy of active FES vs. passive FES, as measured by changes in behavioral measures. The investigators hypothesize that improvements in motor function will be significantly greater using the active FES therapy than the passive FES therapy. Aim 2: To investigate the relationship between brain functional activation patterns and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain fMRI and EEG measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES. Aim 3: To investigate the relationship between brain white matter integrity and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain DTI measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.
Interventions
FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
A functional magnetic resonance image will be collected.
EEG electrodes will be attached to the subject's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.
Sponsors
Study design
Eligibility
Inclusion criteria
* New-onset ischemic stroke 12 months prior - chronic time frame; * Right hand dominant - affected arm; * Mild to moderate unilateral upper extremity impairment or severe unilateral upper extremity impairment; * No upper extremity injury or conditions that limited use prior to the stroke; * Must be able to provide informed consent on their own behalf.
Exclusion criteria
* Inability to competently participate in study procedures * Concurrent upper extremity therapy, other neurological or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Research Arm Test Scores | baseline, 7 weeks, 10 weeks, 4 months | The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. Scores will be reported for baseline, mid (\ 7 weeks), post (\ 10 weeks), and end of study, up to 4 months. |
| Stroke Impact Scale | baseline, 7 weeks, 10 weeks, 4 months | The Stroke Impact Scale, or SIS, was created to assess changes in impairments, activities and participation following a stroke. Scores on the SIS will provide an index of clinically meaningful change representing the change in the patient's mental and physical abilities concurrent with their performance on the verbal fluency and memory tasks. The 4 physical function domains (strength, hand function, activities of daily living (ADL)/instrumental activities of daily living (IADL), and mobility) will be collapsed to a physical function subscale. All domain scores range from 0 to 100 with 100 being the best. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nine Hole Peg Test (9HPT) | baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months | The 9-HPT is a quick and easy to administer tool for screening fine motor problems in participants. It is a timed test in which nine pegs are inserted and removed from nine holes in the pegboard with each hand. Measured at 5 time points over the length of the study. |
| Motor Activity Log (MAL): Amount of Use | baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months | The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study. The Amount of Use scoring is as follows (intermediate scores are possible, 0.5 between each whole number): * 0 - Did not use my weaker arm (not used). * 1 - Occasionally used my weaker arm, but only very rarely (very rarely). * 2 - Sometimes used my weaker arm but did the activity most of the time with my stronger arm (rarely). * 3 - Used my weaker arm about half as much as before the stroke (half pre-stroke). * 4 - Used my weaker arm almost as much as before the stroke (3/4 pre-stroke). * 5 - Used my weaker arm as often as before the stroke (same as pre-stroke). |
| Motor Activity Log (MAL): Quality of Movement | baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months | The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study. The Quality of Movement was scored as follows (intermediate scores 0.5 between whole numbers are possible): * 0 - The weaker arm was not used at all for that activity (never). * 1 - The weaker arm was moved during that activity but was not helpful (very poor). * 2 - The weaker arm was of some use during that activity but needed some help from the stronger arm or moved very slowly or with difficulty (poor). * 3 - The weaker arm was used for the purpose indicated but movements were slow or were made with only some effort (fair). * 4 - The movements made by the weaker arm were almost normal, but were not quite as fast or accurate as normal (almost normal). * 5 - The ability to use the weaker arm for that activity was as good as before the stroke (normal). |
| Signal Change in Functional Magnetic Resonance Imaging (MRI) | baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months | To compare the percent signal change in the functional MRI activations before and after functional stimulation. |
| Hand Grip Strength | baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months | Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study. |
| Center for Epidemiologic Studies Depression Scale (CES-D) | 4 months | The CES-D is a self-report scale and includes 20 items that survey mood, somatic complaints, interactions with others, and motor functioning in the past week. Total possible score 0-60, with the higher score indicating more symptoms of depression. Assessed at 5 time points over the length of the study. |
| Change in Modified Ashworth Scale (MAS) | 4 months | The MAS measures spasticity where 0 is no increase in muscle tone to 4 where affected part is in rigid in flexion or extension. Assessed at 5 time points over the length of the study. |
| Change in Electroencephalogram (EEG) Response Strength | baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months | EEG was recorded in microvolts (µV) from electrodes C4/C3 during periods of left arm imagery and right arm imagery. EEG Response strength is defined as the spectral power in the mu + beta frequency band (8-30 Hz), averaged over the BCI trials. For each participant and time point, a ratio was computed: Ratio = Power\_Left Imagery / Power\_Right Imagery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Passive FES Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment. | 42 |
| Active FES Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG. | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Passive FES | Total | Active FES |
|---|---|---|---|
| Age, Continuous | 67.38 years | 67.03 years | 66.67 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 83 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 78 Participants | 38 Participants |
| Region of Enrollment United States | 42 participants | 84 participants | 42 participants |
| Sex: Female, Male Female | 18 Participants | 39 Participants | 21 Participants |
| Sex: Female, Male Male | 24 Participants | 45 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
Action Research Arm Test Scores
The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. Scores will be reported for baseline, mid (\ 7 weeks), post (\ 10 weeks), and end of study, up to 4 months.
Time frame: baseline, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data for all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Action Research Arm Test Scores | baseline | 28.10 score on a scale | Standard Deviation 17.84 |
| Passive FES | Action Research Arm Test Scores | 7 weeks | 29.95 score on a scale | Standard Deviation 17.3 |
| Passive FES | Action Research Arm Test Scores | 10 weeks | 32.53 score on a scale | Standard Deviation 16.97 |
| Passive FES | Action Research Arm Test Scores | 4 months | 31.78 score on a scale | Standard Deviation 16.85 |
| Active FES | Action Research Arm Test Scores | 4 months | 34.10 score on a scale | Standard Deviation 18.57 |
| Active FES | Action Research Arm Test Scores | baseline | 27.76 score on a scale | Standard Deviation 18.38 |
| Active FES | Action Research Arm Test Scores | 10 weeks | 32.83 score on a scale | Standard Deviation 18.6 |
| Active FES | Action Research Arm Test Scores | 7 weeks | 30.18 score on a scale | Standard Deviation 18.3 |
Stroke Impact Scale
The Stroke Impact Scale, or SIS, was created to assess changes in impairments, activities and participation following a stroke. Scores on the SIS will provide an index of clinically meaningful change representing the change in the patient's mental and physical abilities concurrent with their performance on the verbal fluency and memory tasks. The 4 physical function domains (strength, hand function, activities of daily living (ADL)/instrumental activities of daily living (IADL), and mobility) will be collapsed to a physical function subscale. All domain scores range from 0 to 100 with 100 being the best.
Time frame: baseline, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data at all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Stroke Impact Scale | 10 weeks | 69.97 score on a scale | Standard Deviation 22.64 |
| Passive FES | Stroke Impact Scale | 4 months | 59.86 score on a scale | Standard Deviation 14.5 |
| Passive FES | Stroke Impact Scale | 7 weeks | 70.29 score on a scale | Standard Deviation 19.81 |
| Passive FES | Stroke Impact Scale | baseline | 61.90 score on a scale | Standard Deviation 24.68 |
| Active FES | Stroke Impact Scale | 10 weeks | 67.35 score on a scale | Standard Deviation 21.24 |
| Active FES | Stroke Impact Scale | 7 weeks | 68.22 score on a scale | Standard Deviation 22 |
| Active FES | Stroke Impact Scale | 4 months | 78.49 score on a scale | Standard Deviation 14.61 |
| Active FES | Stroke Impact Scale | baseline | 66.07 score on a scale | Standard Deviation 23.32 |
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a self-report scale and includes 20 items that survey mood, somatic complaints, interactions with others, and motor functioning in the past week. Total possible score 0-60, with the higher score indicating more symptoms of depression. Assessed at 5 time points over the length of the study.
Time frame: 4 months
Population: CES-D data were not collected in order to reduce participant burden associated with completing multiple assessments during study visits. The protocol was not amended to reflect this.
Change in Electroencephalogram (EEG) Response Strength
EEG was recorded in microvolts (µV) from electrodes C4/C3 during periods of left arm imagery and right arm imagery. EEG Response strength is defined as the spectral power in the mu + beta frequency band (8-30 Hz), averaged over the BCI trials. For each participant and time point, a ratio was computed: Ratio = Power\_Left Imagery / Power\_Right Imagery.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data at all time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Change in Electroencephalogram (EEG) Response Strength | Baseline 2 | 0.855 ratio | Standard Deviation 0.228 |
| Passive FES | Change in Electroencephalogram (EEG) Response Strength | 10 weeks | 0.957 ratio | Standard Deviation 0.171 |
| Passive FES | Change in Electroencephalogram (EEG) Response Strength | 7 weeks | 0.970 ratio | Standard Deviation 0.205 |
| Passive FES | Change in Electroencephalogram (EEG) Response Strength | 4 months | 1.125 ratio | Standard Deviation 0.131 |
| Passive FES | Change in Electroencephalogram (EEG) Response Strength | Baseline 1 | 1.120 ratio | Standard Deviation 0.119 |
| Active FES | Change in Electroencephalogram (EEG) Response Strength | 4 months | 1.228 ratio | Standard Deviation 0.083 |
| Active FES | Change in Electroencephalogram (EEG) Response Strength | Baseline 1 | 0.882 ratio | Standard Deviation 0.09 |
| Active FES | Change in Electroencephalogram (EEG) Response Strength | Baseline 2 | 1.145 ratio | Standard Deviation 0.126 |
| Active FES | Change in Electroencephalogram (EEG) Response Strength | 7 weeks | 1.236 ratio | Standard Deviation 0.113 |
| Active FES | Change in Electroencephalogram (EEG) Response Strength | 10 weeks | 1.328 ratio | Standard Deviation 0.234 |
Change in Modified Ashworth Scale (MAS)
The MAS measures spasticity where 0 is no increase in muscle tone to 4 where affected part is in rigid in flexion or extension. Assessed at 5 time points over the length of the study.
Time frame: 4 months
Population: MAS data were not collected in order to reduce participant burden associated with completing multiple assessments during study visits. The protocol was not amended to reflect this.
Hand Grip Strength
Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data at all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Hand Grip Strength | baseline 2 | 32.86 kilograms | Standard Deviation 19.01 |
| Passive FES | Hand Grip Strength | 10 weeks | 37.45 kilograms | Standard Deviation 17.43 |
| Passive FES | Hand Grip Strength | 7 weeks | 34.66 kilograms | Standard Deviation 18.11 |
| Passive FES | Hand Grip Strength | 4 months | 37.37 kilograms | Standard Deviation 16.68 |
| Passive FES | Hand Grip Strength | baseline 1 | 32.95 kilograms | Standard Deviation 18.69 |
| Active FES | Hand Grip Strength | 4 months | 38.68 kilograms | Standard Deviation 17.32 |
| Active FES | Hand Grip Strength | baseline 1 | 31.54 kilograms | Standard Deviation 18.61 |
| Active FES | Hand Grip Strength | baseline 2 | 31.10 kilograms | Standard Deviation 18.82 |
| Active FES | Hand Grip Strength | 7 weeks | 34.78 kilograms | Standard Deviation 17.92 |
| Active FES | Hand Grip Strength | 10 weeks | 37.29 kilograms | Standard Deviation 18.56 |
Motor Activity Log (MAL): Amount of Use
The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study. The Amount of Use scoring is as follows (intermediate scores are possible, 0.5 between each whole number): * 0 - Did not use my weaker arm (not used). * 1 - Occasionally used my weaker arm, but only very rarely (very rarely). * 2 - Sometimes used my weaker arm but did the activity most of the time with my stronger arm (rarely). * 3 - Used my weaker arm about half as much as before the stroke (half pre-stroke). * 4 - Used my weaker arm almost as much as before the stroke (3/4 pre-stroke). * 5 - Used my weaker arm as often as before the stroke (same as pre-stroke).
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data at all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Motor Activity Log (MAL): Amount of Use | baseline 2 | 1.052 score on a scale | Standard Deviation 0.2902 |
| Passive FES | Motor Activity Log (MAL): Amount of Use | 10 weeks | 1.631 score on a scale | Standard Deviation 0.2813 |
| Passive FES | Motor Activity Log (MAL): Amount of Use | 7 weeks | 1.413 score on a scale | Standard Deviation 0.3252 |
| Passive FES | Motor Activity Log (MAL): Amount of Use | 4 months | 1.750 score on a scale | Standard Deviation 0.3137 |
| Passive FES | Motor Activity Log (MAL): Amount of Use | baseline 1 | 0.9888 score on a scale | Standard Deviation 0.3004 |
| Active FES | Motor Activity Log (MAL): Amount of Use | 4 months | 2.603 score on a scale | Standard Deviation 0.3151 |
| Active FES | Motor Activity Log (MAL): Amount of Use | baseline 1 | 1.280 score on a scale | Standard Deviation 0.3071 |
| Active FES | Motor Activity Log (MAL): Amount of Use | baseline 2 | 1.452 score on a scale | Standard Deviation 0.3665 |
| Active FES | Motor Activity Log (MAL): Amount of Use | 7 weeks | 1.750 score on a scale | Standard Deviation 0.2934 |
| Active FES | Motor Activity Log (MAL): Amount of Use | 10 weeks | 2.048 score on a scale | Standard Deviation 0.2766 |
Motor Activity Log (MAL): Quality of Movement
The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study. The Quality of Movement was scored as follows (intermediate scores 0.5 between whole numbers are possible): * 0 - The weaker arm was not used at all for that activity (never). * 1 - The weaker arm was moved during that activity but was not helpful (very poor). * 2 - The weaker arm was of some use during that activity but needed some help from the stronger arm or moved very slowly or with difficulty (poor). * 3 - The weaker arm was used for the purpose indicated but movements were slow or were made with only some effort (fair). * 4 - The movements made by the weaker arm were almost normal, but were not quite as fast or accurate as normal (almost normal). * 5 - The ability to use the weaker arm for that activity was as good as before the stroke (normal).
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data at all timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Motor Activity Log (MAL): Quality of Movement | baseline 2 | 1.073 score on a scale | Standard Deviation 0.313 |
| Passive FES | Motor Activity Log (MAL): Quality of Movement | 10 weeks | 1.557 score on a scale | Standard Deviation 0.2645 |
| Passive FES | Motor Activity Log (MAL): Quality of Movement | 7 weeks | 1.363 score on a scale | Standard Deviation 0.36 |
| Passive FES | Motor Activity Log (MAL): Quality of Movement | 4 months | 1.854 score on a scale | Standard Deviation 0.2726 |
| Passive FES | Motor Activity Log (MAL): Quality of Movement | baseline 1 | 0.9564 score on a scale | Standard Deviation 0.2786 |
| Active FES | Motor Activity Log (MAL): Quality of Movement | 4 months | 2.541 score on a scale | Standard Deviation 0.348 |
| Active FES | Motor Activity Log (MAL): Quality of Movement | baseline 1 | 1.219 score on a scale | Standard Deviation 0.3305 |
| Active FES | Motor Activity Log (MAL): Quality of Movement | baseline 2 | 1.372 score on a scale | Standard Deviation 0.369 |
| Active FES | Motor Activity Log (MAL): Quality of Movement | 7 weeks | 1.846 score on a scale | Standard Deviation 0.2713 |
| Active FES | Motor Activity Log (MAL): Quality of Movement | 10 weeks | 2.164 score on a scale | Standard Deviation 0.3438 |
Nine Hole Peg Test (9HPT)
The 9-HPT is a quick and easy to administer tool for screening fine motor problems in participants. It is a timed test in which nine pegs are inserted and removed from nine holes in the pegboard with each hand. Measured at 5 time points over the length of the study.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Nine Hole Peg Test (9HPT) | Baseline visit 2 | 59.53 seconds | Standard Deviation 4.629 |
| Passive FES | Nine Hole Peg Test (9HPT) | 10 weeks | 59.07 seconds | Standard Deviation 5.047 |
| Passive FES | Nine Hole Peg Test (9HPT) | 7 weeks | 59.65 seconds | Standard Deviation 3.681 |
| Passive FES | Nine Hole Peg Test (9HPT) | 4 months | 58.15 seconds | Standard Deviation 5.236 |
| Passive FES | Nine Hole Peg Test (9HPT) | Baseline visit 1 | 59.89 seconds | Standard Deviation 4.78 |
| Active FES | Nine Hole Peg Test (9HPT) | 4 months | 56.29 seconds | Standard Deviation 3.935 |
| Active FES | Nine Hole Peg Test (9HPT) | Baseline visit 1 | 59.07 seconds | Standard Deviation 4.656 |
| Active FES | Nine Hole Peg Test (9HPT) | Baseline visit 2 | 59.24 seconds | Standard Deviation 4.676 |
| Active FES | Nine Hole Peg Test (9HPT) | 7 weeks | 58.52 seconds | Standard Deviation 5.066 |
| Active FES | Nine Hole Peg Test (9HPT) | 10 weeks | 58.64 seconds | Standard Deviation 5.565 |
Signal Change in Functional Magnetic Resonance Imaging (MRI)
To compare the percent signal change in the functional MRI activations before and after functional stimulation.
Time frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Population: Some participants did not provide data at all time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Passive FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | Baseline 2 | 1.003 percent signal change | Standard Deviation 0.459 |
| Passive FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | 10 weeks | 1.117 percent signal change | Standard Deviation 0.581 |
| Passive FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | 7 weeks | 1.130 percent signal change | Standard Deviation 0.518 |
| Passive FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | 4 months | 1.121 percent signal change | Standard Deviation 0.423 |
| Passive FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | Baseline 1 | 1.136 percent signal change | Standard Deviation 0.466 |
| Active FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | 4 months | 1.192 percent signal change | Standard Deviation 0.482 |
| Active FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | Baseline 1 | 1.203 percent signal change | Standard Deviation 0.461 |
| Active FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | Baseline 2 | 1.153 percent signal change | Standard Deviation 0.44 |
| Active FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | 7 weeks | 1.108 percent signal change | Standard Deviation 0.461 |
| Active FES | Signal Change in Functional Magnetic Resonance Imaging (MRI) | 10 weeks | 1.156 percent signal change | Standard Deviation 0.583 |