Transcutaneous Stimulation in Spinal Cord Injury

NCT05180227 | Completed Results FDA Device

• 2 other identifiers: B3706-MIK1RX003706
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Blood pressure; Orthostatic hypotension; Transcutaneous stimulation; Cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Seated Systolic Blood Pressure

  Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg.

  From enrollment to the end of the last study visit, approximately 30 days.

Study Arms (2)

Without Stimulation

NO INTERVENTION

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

With Stimulation

ACTIVE COMPARATOR

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

Device: DS8R

Interventions

DS8R DEVICE

transcutaneous stimulation of the spinal cord.

Also known as: Transcutaneous Stimulation

With Stimulation

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Related Publications (1)

• 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.

  PMID: 38156073 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Hypotension, Orthostatic; Cardiovascular Diseases

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Jill Maria Wecht
• Organization: James J Peters VA Medical Center

JM.Wecht@va.gov

(718) 584-9000

Study Officials

• Caitlyn Peters, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to which stimulation parameters they are receiving.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: All participants will complete transcutaneous stimulation mapping sessions to determine the optimal parameters to increase and maintain systolic blood pressure between 110-130 mmHg.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 6, 2022
• Study Start: June 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: September 22, 2025
• Results First Posted: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)