Transcutaneous Stimulation in Spinal Cord Injury

NCT ID: NCT05180227

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-07-31

Brief Summary

Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.

Detailed Description

Although life expectancies have improved in the SCI population, longevity remains below the general population, due to increased incidence of cardiovascular disease, which is the leading cause of mortality in individuals with chronic SCI. Autonomic nervous system dysfunction and blood pressure instability contribute to the increased cardiovascular disease risk in the SCI population; however, because a majority of individuals with SCI remain asymptomatic the diagnosis and treatment of blood pressure instability is not a clinical priority. This is due, in part, to lack of safe and effective interventions, even though mounting evidence strongly supports adverse effects of blood pressure instability on the cerebral circulation, cognitive function, and quality of life. Identifying individualized transcutaneous stimulation parameters that safely and effectively increase and stabilize blood pressure in hypotensive individuals with SCI will provide the foundational evidence to support eventual wide-spread clinical utility throughout the VA healthcare system. 10 participants who are cleared, will go through multiple mapping sessions to find out the most appropriate electrode placement to increase seated blood pressure. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Without Stimulation

Seated blood pressure without transcutaneous spinal cord stimulation will be assessed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

With Stimulation

Seated blood pressure with transcutaneous spinal cord stimulation will be assessed.

Group Type: ACTIVE_COMPARATOR

DS8R

Intervention Type: DEVICE

transcutaneous stimulation of the spinal cord.

Interventions

DS8R

transcutaneous stimulation of the spinal cord.

Intervention Type: DEVICE

Other Intervention Names

Transcutaneous Stimulation

Eligibility Criteria

Inclusion Criteria

• above the age of 18 years old
• individuals with traumatic spinal cord injuries at or above T6

• duration of injury if more than 1 year
• non-ambulatory
• American spinal injury association scale A, B or C
• able to provide consent
• non-ventilator
• hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)

Exclusion Criteria

• acute illness or infection
• documented history of controlled or uncontrolled diabetes
• any other neurological disease other than spinal cord injury
• cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke)
• present of history of thrombosis in the last 12 months, severe contractures
• pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caitlyn Peters, PhD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Locations

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Countries

United States

References

Peters CG, Harel NY, Weir JP, Wu YK, Murray LM, Chavez J, Fox FE, Cardozo CP, Wecht JM. Transcutaneous Spinal Cord Stimulation to Stabilize Seated Systolic Blood Pressure in Persons With Chronic Spinal Cord Injury: Protocol Development. Neurotrauma Rep. 2023 Dec 19;4(1):838-847. doi: 10.1089/neur.2023.0063. eCollection 2023.

Reference Type: DERIVED

PMID: 38156073 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IK1RX003706

Identifier Type: NIH

Identifier Source: secondary_id

View Link

B3706-M

Identifier Type: -

Identifier Source: org_study_id