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The overall goal is to develop new clinical approaches to restore limb function after spinal cord injury (SCI). Corticospinal tract (CST) axons are involved in controlling limb function. Paired pulse induced spike-timing dependent plasticity (STDP) enhances synaptic strength between residual CST axons and spinal motoneurons (SMNs) resulting in temporary improvements in limb function in humans with incomplete SCI. Motor training will be combined with paired-pulse STDP stimulation to further enhance plasticity and behavioral recovery.
To induce STDP with paired pulse, corticospinal volleys evoked by either transcranial magnetic stimulation over the primary motor cortex for upper extremities or electrical stimulation over the thoracic spine for lower extremities arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles, 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of corresponding peripheral nerves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STDP | Active Comparator | Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. |
|
| STDP + Training | Active Comparator | Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation. |
|
| Sham STDP + Training | Active Comparator | Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation. |
|
| Multisite-STDP + Training | Other | Prospective Single Cohort Multisite-Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STDP | Other | Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment | The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) assessment is a standardized test of functional abilities of the hand. We measure time required to complete the GRASSP test for upper extremity functional assessment. 10-m walk test is used to measure walking speed for lower extremity functional assessment. The time to complete the task is assessed in seconds for both measurements and normalized as percentage of Baseline. Normalization to baseline allows comparison across two different tasks. For STDP, STDP+Training, and Sham-STDP+Training groups, either GRASSP or 10-m walk test was performed in each participant depending on the targeted muscle. For Multisite-STDP + Training group, both GRASSP and 10-m walk test were performed in each participant and the average of two tests were reported below. | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline, after 20 and 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of Motor Evoked Potential (MEP) | We measure amplitude of a motor evoked potential evoked by transcranial magnetic stimulation (TMS) or thoracic spine stimulation. The amplitude of MEP is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is necessary to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury. |
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Inclusion Criteria:
Participants who are unimpaired healthy controls:
Participants who have had a spinal cord injury:
Exclusion Criteria:
Exclusion criteria for enrollment For SCI and Healthy Control Subjects (4-8 exclusion for non-invasive brain stimulation only):
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| Name | Affiliation | Role |
|---|---|---|
| Martin Oudega, PhD | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-5000 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | STDP | Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Participants will complete 10 STDP study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. |
| FG001 | STDP + Training | Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Training: The participant will be asked to perform exercises using their upper and lower extremities. Participants will complete 10 STDP + Training study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. |
| FG002 | Sham STDP + Training | Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation. Training: The participant will be asked to perform exercises using their upper and lower extremities. Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Participants will complete 10 Sham STDP + Training study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. |
| FG003 | Multisite-STDP + Training | Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation. Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Training: The participant will be asked to perform exercises using their upper and lower extremities. Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours. Baseline, post 20, and post 40 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Baseline and post 40 measurements will be collected for the following measurements: ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions. Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | STDP | Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Participants will complete 10 STDP study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. |
| 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 | Functional Assessment | The Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) assessment is a standardized test of functional abilities of the hand. We measure time required to complete the GRASSP test for upper extremity functional assessment. 10-m walk test is used to measure walking speed for lower extremity functional assessment. The time to complete the task is assessed in seconds for both measurements and normalized as percentage of Baseline. Normalization to baseline allows comparison across two different tasks. For STDP, STDP+Training, and Sham-STDP+Training groups, either GRASSP or 10-m walk test was performed in each participant depending on the targeted muscle. For Multisite-STDP + Training group, both GRASSP and 10-m walk test were performed in each participant and the average of two tests were reported below. | The number of participants analyzed is different from overall number of participants because some participants could not perform the GRASSP and/or 10-m walk test. Follow-up was performed only with available participants. | Posted | Mean | Standard Deviation | percentage of Baseline | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline, after 20 and 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
The adverse event data is collected from baseline to completion of study visits, an average of 2~3 weeks for Arms 1-3. The longer experiment, Arm 4, involves ~50 visits (40 sessions + baseline, post 20, post 40, and follow-up assessments). This gives a total of 10~15 weeks.
Arm 1 includes all participants who were monitored for adverse events even if they did not complete the study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STDP | Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Participants will complete 10 STDP study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reagan Morehouse | Hines VA | 312-238-2993 | rmorehouse@sralab.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2021 | Feb 14, 2022 | Prot_SAP_001.pdf |
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| 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 |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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participants will not know if they receive real or sham stimulation
|
| Training | Behavioral | The participant will be asked to perform exercises using their hands and arms. |
|
| Sham STDP | Other | Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. |
|
| Multisite-STDP | Other | Paired stimulation will be given to the brain bilaterally, thoracic spine, and several peripheral nerve so that the messages are received at the spinal cord at predetermined time. |
|
| Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group. |
| Maximum Voluntary Contraction | We measure maximum voluntary contraction (MVC) of muscles recorded by electromyography (EMG) in the targeted muscle(s). Average of muscles was reported for Multisite-STDP + Training group. The maximum voluntary contraction is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is needed to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury. | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group. |
| ISNCSCI-motor Scores | Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Motor part of the exam is completed through the testing of key muscle functions corresponding to 10 myotomes (C5-T1 and L2-S1) for right and left side separately. The strength of each muscle function is graded on a six-point scale ranging from 0 meaning complete paralysis to 5 meaning full strength. The total motor score is sum of all motor scores across 10 myotomes for both sides and therefore ranges from 0-100. Higher scores represent better outcome. We reported the total motor score. | ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training. |
| ISNCSCI-sensory Scores | Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Sensory part of the exam is completed through the testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body. At each of these key points, two aspects of sensation are examined: light touch and pin prick (sharp-dull discrimination). Appreciation of light touch and pin prick sensation at each of the key points is separately scored on a three-point scale; 0-absent, 1-altered, and 2-normal or intact. Therefore, 56 is the maximum score for both light touch and pin prick and the total sensory score ranges from 0 to 112. Higher scores represent better outcome. We reported the total sensory score. | ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training. |
| SCI-QOL-ambulation | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Ambulation subdomain assesses the ability to engage in walking activities in different locations that vary based on speed, time and condition and the ability to manage stairs under different conditions. Higher scores on Ambulation subdomain represent better outcome. | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
| SCI-QOL-self-care | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Self-care subdomain assesses an individual's ability to perform daily self-care activities such as eating, dressing, grooming, and bathing. Higher scores on Self-care subdomain represent better outcome. | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
| SCI-QOL- Bowel Management Difficulties | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bowel management difficulties subdomain measures a range of difficulties associated with bowel management, including an ability to carry out a bowel program; concerns about incontinence and bowel accidents; concerns about difficulty implementing a bowel program; and the impact of bowel management on everyday living. Higher scores on bowel management difficulties subdomain represent better outcome. | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
| SCI-QOL- Bladder Management Difficulties | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bladder management difficulties subdomain measures a range of difficulties associated with bladder management, including ability to carry out a bladder program; worry about bladder accidents; concerns about implementing one's bladder program; and impact on everyday living. Higher scores on bladder management difficulties subdomain represent better outcome. | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
| Some subjects were unable to commit to the training study. |
|
| BG001 | STDP + Training | Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Training: The participant will be asked to perform exercises using their upper and lower extremities. Participants will complete 10 STDP + Training study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. |
| BG002 | Sham STDP + Training | Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation. Training: The participant will be asked to perform exercises using their upper and lower extremities. Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Participants will complete 10 Sham STDP + Training study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. |
| BG003 | Multisite-STDP + Training | Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation. Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Training: The participant will be asked to perform exercises using their upper and lower extremities. Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours. Baseline, post 20, and post 40 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Baseline and post 40 measurements will be collected for the following measurements: ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions. Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Time post injury | Mean | Standard Deviation | years |
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| Secondary | Amplitude of Motor Evoked Potential (MEP) | We measure amplitude of a motor evoked potential evoked by transcranial magnetic stimulation (TMS) or thoracic spine stimulation. The amplitude of MEP is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is necessary to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury. | Follow up was done with available participants. | Posted | Mean | Standard Deviation | percentage of Baseline | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group. |
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| Secondary | Maximum Voluntary Contraction | We measure maximum voluntary contraction (MVC) of muscles recorded by electromyography (EMG) in the targeted muscle(s). Average of muscles was reported for Multisite-STDP + Training group. The maximum voluntary contraction is assessed in millivolts and normalized as percentage of Baseline. Normalization to baseline is needed to allow comparison across different muscles because the targeted muscle is different for each individual depending on the level of injury. | Follow-up was done only with available participants. | Posted | Mean | Standard Deviation | percentage of Baseline | Measured at baseline, after 10-20 sessions, and follow up (after 6 months) for STDP, STDP+Training, and Sham-STDP+Training groups . Measured at baseline and after 20 and 40 sessions for Multisite-STDP + Training group. |
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| Secondary | ISNCSCI-motor Scores | Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Motor part of the exam is completed through the testing of key muscle functions corresponding to 10 myotomes (C5-T1 and L2-S1) for right and left side separately. The strength of each muscle function is graded on a six-point scale ranging from 0 meaning complete paralysis to 5 meaning full strength. The total motor score is sum of all motor scores across 10 myotomes for both sides and therefore ranges from 0-100. Higher scores represent better outcome. We reported the total motor score. | We performed ISNCSCI exam only for "Multiside-STDP+training" group but not in the other groups ("STDP", "STDP + Training" and "Sham STDP + Training"). Therefore the results were provided only for "Multiside-STDP+training" group. | Posted | Mean | Standard Deviation | scores on a scale | ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training. |
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| Secondary | ISNCSCI-sensory Scores | Neurological recovery was measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam. Sensory part of the exam is completed through the testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body. At each of these key points, two aspects of sensation are examined: light touch and pin prick (sharp-dull discrimination). Appreciation of light touch and pin prick sensation at each of the key points is separately scored on a three-point scale; 0-absent, 1-altered, and 2-normal or intact. Therefore, 56 is the maximum score for both light touch and pin prick and the total sensory score ranges from 0 to 112. Higher scores represent better outcome. We reported the total sensory score. | We performed ISNCSCI exam only for "Multiside-STDP+training" group but not in the other groups ("STDP", "STDP + Training" and "Sham STDP + Training"). Therefore the results were provided only for "Multiside-STDP+training" group. | Posted | Mean | Standard Deviation | scores on a scale | ISNCSCI was performed at baseline and after 40 sessions of Multisite-STDP+Training. |
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| Secondary | SCI-QOL-ambulation | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Ambulation subdomain assesses the ability to engage in walking activities in different locations that vary based on speed, time and condition and the ability to manage stairs under different conditions. Higher scores on Ambulation subdomain represent better outcome. | We performed SCI-QOL exam only for "Multiside-STDP+training" group but not in the other groups ("STDP", "STDP + Training" and "Sham STDP + Training"). Therefore the results were provided only for "Multiside-STDP+training" group. Follow up was done with available participants. | Posted | Mean | Standard Deviation | T-scores | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
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| Secondary | SCI-QOL-self-care | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Self-care subdomain assesses an individual's ability to perform daily self-care activities such as eating, dressing, grooming, and bathing. Higher scores on Self-care subdomain represent better outcome. | We performed SCI-QOL exam only for "Multiside-STDP+training" group but not in the other groups ("STDP", "STDP + Training" and "Sham STDP + Training"). Therefore the results were provided only for "Multiside-STDP+training" group. Follow up was done with available participants. | Posted | Mean | Standard Deviation | T-scores | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
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| Secondary | SCI-QOL- Bowel Management Difficulties | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bowel management difficulties subdomain measures a range of difficulties associated with bowel management, including an ability to carry out a bowel program; concerns about incontinence and bowel accidents; concerns about difficulty implementing a bowel program; and the impact of bowel management on everyday living. Higher scores on bowel management difficulties subdomain represent better outcome. | We performed SCI-QOL exam only for "Multiside-STDP+training" group but not in the other groups ("STDP", "STDP + Training" and "Sham STDP + Training"). Therefore the results were provided only for "Multiside-STDP+training" group. Follow up was done with available participants. | Posted | Mean | Standard Deviation | T-scores | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
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| Secondary | SCI-QOL- Bladder Management Difficulties | We used questionnaire to assess changes in quality of life. The name of the questionnaire is Spinal Cord Injury Quality of Life (SCI-QOL) and we used four subdomains: ambulation, self-care, bowel management difficulties, and bladder management difficulties. Scores on all subdomains of SCI-QOL use a standardized T metric, with a mean of 50 and a standard deviation of 10. Bladder management difficulties subdomain measures a range of difficulties associated with bladder management, including ability to carry out a bladder program; worry about bladder accidents; concerns about implementing one's bladder program; and impact on everyday living. Higher scores on bladder management difficulties subdomain represent better outcome. | We performed SCI-QOL exam only for "Multiside-STDP+training" group but not in the other groups ("STDP", "STDP + Training" and "Sham STDP + Training"). Therefore the results were provided only for "Multiside-STDP+training" group. Follow up was done with available participants. | Posted | Mean | Standard Deviation | T-scores | Measured at baseline, after 40 sessions, and follow up (after 9 months) for Multisite-STDP + Training group. |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | STDP + Training | Paired stimulation (STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. STDP: Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time. Training: The participant will be asked to perform exercises using their upper and lower extremities. Participants will complete 10 STDP + Training study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Sham STDP + Training | Sham or fake paired stimulation (Sham STDP) will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Motor training will follow stimulation. Training: The participant will be asked to perform exercises using their upper and lower extremities. Sham STDP: Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times. Participants will complete 10 Sham STDP + Training study visits each lasting ~2 hours. Baseline and post 10 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Follow-up measurements will be done after 6 months with available participants for MEPs, MVC, and functional measurements. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Multisite-STDP + Training | Prospective Single Cohort Multisite-Paired stimulation (Multisite-STDP) will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Motor training will follow paired stimulation. Multisite-STDP: Paired stimulation will be given to the brain, spinal cord and peripheral nerves so that the messages are received at the spinal cord at predetermined time. Training: The participant will be asked to perform exercises using their upper and lower extremities. Participants will complete 40 multisite-STDP + Training study visits each lasting ~2 hours. Baseline, post 20, and post 40 measurements will be collected for the following measurements: Changes in TMS measurements in the form of motor evoked potentials (MEPs). Changes in the maximum voluntary contraction (MVC) will be measured using surface EMG. Functional measurements: GRASSP, will measure changes in the time it takes to complete hand tasks; 10-m walk test, will measure changes in walking speed. Baseline and post 40 measurements will be collected for the following measurements: ISNCSCI, will measure neurologic and functional recovery; SCI-QOL, will measure changes in quality of life functions. Follow-up measurements will be done after 9 months with available participants for GRASSP, 10-m walk test, and SCI-QOL. | 0 | 13 | 0 | 13 | 0 | 13 |
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