Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT07674511
Status
Not Yet Recruiting

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Conditions

  • Blood Pressure
  • Cardiovascular Diseases
  • Central Nervous System Disease
  • Hypotension
  • Nervous System Diseases
  • Orthostatic Hypotension
  • Spinal Cord Diseases
  • Spinal Cord Injuries
  • Trauma, Nervous System

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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

Study Details

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: 1. What are the immediate effects of spinal cord transcutaneous stimulation on BP? 2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: participants with chronic SCIs.
    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

Primary Outcome Measure

Systolic blood pressure [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
LeighAnn Martinez, BA
[email protected]
(973)324-3557
Einat Engel-Haber, MD
[email protected]
Gail F Forrest, PhD (PRINCIPAL_INVESTIGATOR)
Steven Kirshblum, MD (SUB_INVESTIGATOR)
Einat Engel-Haber, MD (SUB_INVESTIGATOR)

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By research site
Kessler Foundation· West Orange, NJ

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