An interventional study of Tilt test with stimulation (real-time effects): Intervention 1 and 20 sessions of stimulation (Intervention 2) in Spinal Cord Injuries, Hypotension and Orthostatic Hypotension, sponsored by Kessler Foundation. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
Among 40 studies in Spinal Cord Injuries by Kessler Foundation — 21 open to participants now, 21 under way, none of them phase 3. Spinal Cord Injuries · Kessler Foundation.
Among the 40 studies in Spinal Cord Injuries by Kessler Foundation, this one is the 32nd largest by planned enrollment of the 37 interventional ones, is one of 4 that started in 2026, is one of 24 with no phase, reaches primary completion later than 16 of the 20 other live ones, and was the 38th registered.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 10 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →21 of the 40 studies in Spinal Cord Injuries by Kessler Foundation are open now, in 1 country. Each count lists the studies.
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →40 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 4 started in 2026.
Median enrollment 24 across the 37 interventional studies, 15 across the 3 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
Kessler Foundation is the lead sponsor of 175 studies on the registry; 61 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
5 of the studies in Spinal Cord Injuries by Kessler Foundation that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06841198Kessler FoundationCardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury | 2026-11 |
| NCT06698224Kessler FoundationPaired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI | 2026-11-01 |
| NCT04921592Kessler FoundationUpper Extremity Training for Chronic Cervical Spinal Cord Injury | 2027-06-15 |
| NCT06643312Kessler FoundationTPAD for Recovery of Standing After Severe SCI | 2027-10 |
| NCT06650202Kessler FoundationImproving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation | 2027-11 |
Among the 40 studies in Spinal Cord Injuries by Kessler Foundation, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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: 1. Baseline assessments, including a tilt test and various cardiovascular assessments 2. Mapping stimulation sessions - several days when different stimulation parameters and locations are tested in order to obtain the configurations for the most suitable blood pressure response. 3. Repeat tilt test, with stimulation (intervention 1), with continuous blood pressure monitoring 4. 20 stimulation sessions, each 30-min long, with participants in their wheelchairs (intervention 2) 5. Repeat baseline assessments
Device: Tilt test with stimulation (real-time effects): Intervention 1 · Device: 20 sessions of stimulation (Intervention 2)
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.
Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs
Systolic blood pressure
Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.
Time frame: 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
Time frame: Through study completion, an average of 5 months
duration in tilt test
how long the participant was able to stay in an orthostatic provocation (70 degrees tilt in tilt table)
Time frame: Through study completion, an average of 5 months
Orthostatic symptoms questionnaire
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, an average of 5 months
Plan to share: No
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