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

NCT07674511 | Not Yet Recruiting

• 2 other identifiers: R-1323-261R03HD120505-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

transcutaneous spinal cord stimulation; spinal stimulations; orthostatic hypotension; blood pressure; neuromodulation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• duration in tilt test

  Through study completion, an average of 5 months

• Orthostatic symptoms questionnaire

  Through study completion, an average of 5 months

• 24-hour ABPM OH events - taken at home

  Through study completion, an average of 5 months

• Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores

  Through study completion, an average of 5 months

• Spinal cord injury - quality of life scores

  Through study completion, an average of 5 months

Study Arms (1)

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: 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)

Interventions

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

participants with chronic SCIs.

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.

participants with chronic SCIs.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Persistent hypotension (SBP \< 90mmHg)
• Orthostatic hypotension (OH, a drop of 20/10 mmHg in SBP/DBP within 5 minutes of standing/upright positioning).
• Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.

You may not qualify if:

• Current illness (e.g., infection, a pressure injury that might interfere with the intervention)
• Ventilator-dependent
• History of implanted brain/spine/nerve stimulators
• Cardiac pacemaker/defibrillator or intra-cardiac lines
• Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
• History of seizures
• pregnancy
• Insufficient mental capacity to understand and independently provide consent
• Deemed unsuitable by the study physician

Sponsors & Collaborators

• Kessler Foundation: lead
• Montclair State University: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension; Hypotension, Orthostatic; Spinal Cord Diseases; Cardiovascular Diseases; Trauma, Nervous System; Central Nervous System Diseases; Nervous System Diseases

Interventions

Tilt-Table Test

Condition Hierarchy (Ancestors)

Wounds and Injuries; Vascular Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gail F Forrest, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LeighAnn Martinez, BA

CONTACT

972-324-3557; lmartinez@kesslerfoundation.org

Einat Engel-Haber, MD

CONTACT

ehaber@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research scientist

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)