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Spinal Cord Transcutaneous Stimulation for Blood Pressure in Acute Spinal Cord Injury

This study is looking at how transcutaneous spinal cord stimulation (using a device called Biostim-5) affects blood pressure in people who have had a spinal cord injury recently (within 7 to 30 days). Many people with new spinal cord injuries experience a sudden drop in blood pressure when they sit up or stand, called orthostatic hypotension, which can make rehabilitation difficult. Researchers want to find the best way to use this stimulation to increase blood pressure and reduce symptoms like dizziness during a "sit-up test." They will be looking for the best places on the spine and the best settings for the stimulation. The study is for individuals aged 18-75 with specific types of spinal cord injuries and blood pressure issues. The study aims to enroll 12 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved
You would undergo mapping sessions to find optimal stimulation sites, followed by testing with both active and "sham" (inactive) stimulation. This process is expected to take an average of two weeks.
Compensation
Not stated in the trial record.
Follow-up
Blood pressure measurements will be taken throughout the experiment, which averages two weeks.

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NCT05731986

Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)

Recruiting
NAAges 18–75InterventionalTreatment
Kessler Foundation
~12 participants
Updated 2025-09-02 on ClinicalTrials.gov
What's tested:Orthostatic challengeBiostim-5 transcutaneous spinal stimulation - MappingBiostim-5 transcutaneous spinal stimulation - "Optimal" testingBiostim-5 transcutaneous spinal stimulation - "Sham" testing

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Optimal stimulation sites
Measured over Through Mapping and testing sessions, average of 2 weeks
+3 more outcomes measured

Conditions

Spinal Cord Injuries
Spinal Cord Diseases
Trauma, Nervous System
Nervous System Diseases
Central Nervous System Diseases
Hypotension
Orthostatic Hypotension
Cardiovascular Diseases
Acute Spinal Cord Injury
Blood Pressure

Explore related trials

Orthostatic HypotensionSpinal Cord Injury

Where it's being run

1 sites across 1 states
New Jersey1

Study leadership

  • Gail F Forrest, PhD · PRINCIPAL_INVESTIGATOR · Kessler Foundation

Who to contact

LeighAnn Martinez, BA
[email protected]
(973)324-3557
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

7-30 days after injury
Injury level ≥T2 (thoracic level)
American Spinal Injury Association Impairment Scale (AIS) A-C
Exhibits at least one of the following hypotensive symptoms:

Exclusion

Current illness (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
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
Initiated on new cardiac medications within the past 5 days
Insufficient mental capacity to understand and independently provide consent
Pregnancy
Cancer
Deemed unsuitable by study physician

What this trial measures

  • Optimal stimulation sitesThrough Mapping and testing sessions, average of 2 weeks

    Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).

  • Optimal stimulation frequencyThrough Mapping and testing sessions, average of 2 weeks

    Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).

  • Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BPThroughout the experiment, average of 2 weeks

    A comparison of systolic blood pressure with no stimulation, sham or optimal stimulation during an orthostatic challenge will be performed to assess the efficacy of stimulation.

  • Change in Orthostatic symptoms when stimulation is appliedWill be performed every 5 minutes during the orthostatic tests, average of 2 weeks

    A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), using a scale of 1-10 (10 being the most severe), will be conducted during an orthostatic test to assess the efficacy of stimulation and compare the effects of optimal and sham stimulation.