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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this research is to test the effectiveness of a new therapy, called Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS), for improving walking in people with an incomplete spinal cord injury (SCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) | Experimental | Subjects will participate in the therapy for up to 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCI-TSCS | Other | BCI-TSCS therapy, completed 3-4 times per week, that will include activity-based training, with TSCS activated by BCI system detecting movement attempt. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of related neurological deterioration (LEMS) | Lower Extremity Motor Score (LEMS) to assess lower limb muscle function following the American Spinal Injury Association Impairment Scale (ASIA) guidelines. The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function). | up to 12 months |
| Number of treatment related incidence of adverse events (AEs) | Safety will be reported as the incidence of treatment related AEs as assessed by the study doctor | up to 12 months |
| Number of subjects that complete the study | Safety will be determined by number of subjects that complete the study, as designed. | up to 12 months |
| Walking function using 10 meter walk test (10MWT) | This is a test of short-distance walking function. The subject will be asked to walk at a comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway. Time is measured in meters per seconds. | up to 12 months |
| Walking function using 6 minute walk test (6MWT) | The object of the test is to walk as far as possible for 6 minutes. The subject will walk at a normal pace around a marked course for 6 minutes. The subject may stop to rest and begin again at will. The distance covered indicates aerobic fitness. The further a subject walks, the better their cardiovascular condition. Units are measured in meters. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility measured by Timed Up and Go (TUG) Test | The Timed Up and Go test or TUG test is used to help evaluate mobility. It measures, in seconds, how long it takes subjects to stand up, walk 10 feet, turn around, walk back, and sit down. | up to 12 months. |
| Balance measured by the Berg Balance Scale (BBS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Thruston, DPT | Contact | (305) 243-9301 | cst58@med.miami.edu | |
| Matija Milosevic, PhD | Contact | (305) 243-3572 | mmilosevic@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Matija Milosevic, PhD | University of Miami - MSOM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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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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BBS is an assessment to determine balance. The BBS consists of 14 items scored on a 5-point ordinal scale, ranging from 0 to 4 (0 indicates lowest level of function; 4 indicates highest level of function), with a maximum total score of 56. |
| up to 12 months. |
| Muscular spasticity measured by the Modified Ashworth Scale (MAS) | The Modified Ashworth Scale is a 6-point scale. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity. | up to 12 months. |
| Muscular spasticity measured by the Pendulum Test | The Pendulum Test will be used to measure muscular spasticity. During the pendulum test, the participant will be lying on a therapy mat with the lower leg hanging off the edge of the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. This test will be video recorded and the movement of the knee joint will be measured using software on the computer. Muscular spasticity will be calculated by the number of the Relaxation index (R1 and R2) and compared to norms. | up to 12 months. |
| Walking assistance measured by the Walking Index for Spinal Cord Injury Scale (WISCI II) | WISCI II is an ordinal scale using a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former. | up to 12 months |
| Independence as measured by Spinal Cord Independence Measure (SCIM III) | SCIM III assesses performance in activities of daily living Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence. | up to 12 months |
| Quality of Life using the International Spinal Cord Injury - Quality of Life (ISCI-QOL) | ISCI-QOL consists of three single items on satisfaction with life as a whole, physical health and psychological health using a 0-10 scale where 0=complete dissatisfaction; 10=complete satisfaction. | up to 12 months |
| Quality of Life measured by the Reintegration to Normal Living (RNL) questionnaires | RNL is a self-report questionnaire that assesses a person's satisfaction with performance in life activities. The RNL index assesses mobility, self-care, daily activity, recreational activity, and family roles. The RNL includes 11 declarative statements and a composite score will be calculated. Minimum Score = 0; Maximum Score = 100. Higher scores indicate greater reintegration. | up to 12 months |
| D014947 | Wounds and Injuries |