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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HD120505-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Montclair State University | OTHER |
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The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.
The main questions this study attempts to solve:
We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| participants with chronic SCIs. | Experimental | Participation in this study will take about 5 to 6 months and will include approximately 30 to 40 separate lab visits. Most visits will last about 2 hours, though some of the early visits may take longer. The study consists of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tilt test with stimulation (real-time effects): Intervention 1 | Device | While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation. | 1 month |
| Systolic blood pressure | changes in blood pressure drop with tilt (no stimulation) from baseline testing to tilt test (no stimulation) after 20 sessions of stimulation | Through study completion, an average of 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| duration in tilt test | how long the participant was able to stay in an orthostatic provocation (70 degrees tilt in tilt table) | Through study completion, an average of 5 months |
| Orthostatic symptoms questionnaire |
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Inclusion Criteria:
Individuals with a SCI ≥ 1 year after injury
Injury level ≥ T6 (thoracic level)
AIS grade A-C
Cardiovascular dysfunction characterized by one or more of the following:
Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LeighAnn Martinez, BA | Contact | 972-324-3557 | lmartinez@kesslerfoundation.org | |
| Einat Engel-Haber, MD | Contact | ehaber@kesslerfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Gail F Forrest, PhD | Kessler Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | West Orange | New Jersey | 07052 | United States |
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| 20 sessions of stimulation (Intervention 2) | Device | Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs |
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A designated questionnaire evaluates symptoms such as headaches, dizziness, blurred vision, nausea, weakness, confusion, fatigue, ringing in the ears, and feeling of passing out. Recorded every 5 minutes (or sooner if symptoms worsen). Participants rate each symptom on a scale of 0 to 10, with 10 indicating the highest severity.
| Through study completion, an average of 5 months |
| 24-hour ABPM OH events - taken at home | Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities and their time-points. Conducted before, halfway through, and after the intervention | Through study completion, an average of 5 months |
| Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores | 24-item self-reported tool designed for clinical practice and research to assess symptoms of BP instability. It evaluates the frequency and severity of symptoms during high and low BP events | Through study completion, an average of 5 months |
| Spinal cord injury - quality of life scores | A questionnaire was developed to address the shortage of psychometrically sound and relevant patient-reported outcome measures for clinical care and research in SCI rehabilitation | Through study completion, an average of 5 months |
| Canadian Occupational Performance Measure scores | A semi-structure interview where the individual identifies and measures their areas of difficulty, scoring their performance on the tasks and their satisfaction with their ability | Through study completion, an average of 5 months |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007022 | Hypotension |
| D007024 | Hypotension, Orthostatic |
| D013118 | Spinal Cord Diseases |
| D002318 | Cardiovascular Diseases |
| D020196 | Trauma, Nervous System |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D014652 | Vascular Diseases |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
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| ID | Term |
|---|---|
| D018667 | Tilt-Table Test |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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