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This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for individuals with traumatic spinal cord injury. The study consists of a baseline evaluation and 1-week training period (Week 0), a 4-week stimulation period (Weeks 1-4), and a follow-up visit (Week 5), for a total expected duration of participation for each subject of six weeks.
During the first week of the study, baseline measurements will be recorded for each subject and all eligible subjects and their caregivers will participate in a 1-week "Training Phase." Subsequently, subjects will perform activities of daily living and/or home exercises in conjunction with the ExaStim over a 4-week period in the home setting. In each session, subjects will receive stimulation while performing therapist-prescribed home exercises or activities of daily living. Stimulation must be utilized for a maximum of 300 -minutes per week and a minimum of 125-minutes per week. The time spent using stimulation during home sessions, and the number of sessions that patients perform each week, is flexible and is intended to facilitate the use of ExaStim within each participant's daily routine. Subjects and Clinicians will participate in weekly telehealth check-ins throughout the 4-week period in the home setting and will return to the clinic within one week of the final treatment to complete the final assessments in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Spinal Stimulation in the home setting | Experimental | Subjects will perform activities of daily living in conjunction with the ExaStim over a 4-week period in the home setting. In each session, subjects will receive stimulation while performing therapist-prescribed activities of daily living. Stimulation must be utilized for a maximum of 300 -minutes per week and a minimum of 125-minutes per week. The time spent using stimulation during home sessions, and the number of sessions that patients perform each week, is flexible and is intended to facilitate the use of ExaStim within each participant's daily routine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExaStim Stimulation System | Device | Transcutaneous Spinal Cord Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of device related adverse events | Incidence of device related adverse events over the course of the trial. no scoring requirement | Occurrence over 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure | is an individualized, client-centered instrument designed to measure an individual's self-perception of physical functioning and satisfaction in the activities identified as important by the client. COPM score ranges from 0-50, higher scores mean a better outcome. | change from baseline to week-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craig Rehabilitation Hospital | Denver | Colorado | 80113 | United States | ||
| TryAbility Neurorecovery Center |
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| Patient Global Impression of Change (PGIC) |
The Patient Global Impression of Change Questionnaire is rated on a 10-point scale depicting a patient's rating of overall improvement. This self-reported scale reflects a patient's belief about the efficacy of treatment. score range from 0-10 with lower scores showing considerable imrpovement. |
| score at week 5 |
| Psychosocial Impact of Assistive Devices Scale | The PIADS Questionnaire is a 26-item self-reported questionnaire designed to assess the effects of an assistive device on functional independence, well-being and quality of life. Score range of 0-182 points with higher scores reflecting positive impact. | score at week 5 |
| Capabilities of Upper Extremity Test | The CUE-T is an objective performance measure to assess upper extremity functional limitations in spinal cord injury individuals. CUE-T score ranges from 0 to 140, higher scores mean a better outcome. | maintenance or change from baseline to week 5 |
| Upper Extremity Motor Score | UEMS is a sub score of the ISNSCSCI. The ISNCSCI exam is a standardized tool traditionally used in clinical trials to broadly assess motor and sensory changes in individuals after spinal cord injury. The UEMS, a sub score of the ISNCSCI exam, better reflects meaningful recovery in the arms and hands, an area of utmost importance to individuals living with tetraplegia. The UEMS grades on a scale of 0-50, higher scores mean a better outcome. | maintenance or change from baseline to week 5 |
| Downer Grove |
| Illinois |
| 60515 |
| United States |
| Internation Center for Spinal Cord Injury at the Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02138 | United States |
| Marquette University Neuro Recovery Clinic | Milwaukee | Wisconsin | 53233 | United States |