Transcutaneous Stimulation in Spinal Cord Injury

Spinal Cord Injury Clinical Trial

— SCI  

Official title:

Targeted Transcutaneous Stimulation to Restore Autonomic Cardiovascular Health in Veterans With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180227
• Other study ID #: B3706-M
• Secondary ID: IK1RX003706
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Caitlyn Peters, PhD
• Phone: (718) 584-9000
• Email: Caitlyn.Katzelnick[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 blood pressure and then will perform an orthostatic provocation on a tilt table during stimulation to determine differences with stim and without. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• DS8R
transcutaneous stimulation of the spinal cord.

Diagnostic Test:
• Orthostatic tilt
perform an orthostatic tilt without and with stimulation.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrode placement	Electrodes will be placed on the vertebral midline at the spinous process (T7/T8, T9/10, T11/12, L1/L2). Determine the best electrode placement on the spine that increases blood pressure between 110-120 mmHg for males and 100-120 mmHg for females in the seated position. The best electrode placement will be used to increase blood pressure during an orthostatic tilt.	through study completion, up to 2 years
Primary	Amplitude of TSCS	Amplitude of the stimulation will start at 0mA and increase in increments between 1 - 10mA to determine the best amplitude to increase systolic blood pressure between 110-120 mmHg for males and 100-120 mmHg for females. The same spinous process sites (T7/T8, T9/10, T11/12, L1/L2) will be used. The best amplitude will be used to increase blood pressure during an orthostatic tilt.	through study completion, up to 2 years
Secondary	Systolic blood pressure	Determine the differences in systolic blood pressure during an orthostatic tilt without stimulation and with optimal stimulation.	through study completion, up to 2 years
Secondary	Concentration of Norepinephrine	Determine the differences in norepinephrine during an orthostatic tilt without stimulation and with optimal stimulation.	through study completion, up to 2 years
Secondary	Velocity of Arterial stiffness	Determine the differences in arterial stiffness during an orthostatic tilt without stimulation and with optimal stimulation. Arterial stiffness will be measured using pulse wave velocity of the carotid and femoral arteries. The unit of measure is velocity.	through study completion, up to 2 years
Secondary	Concentration of Renin	Determine the differences in renin during an orthostatic tilt without stimulation and with optimal stimulation.	through study completion, an average of 2 years
Secondary	Concentration of Aldosterone	Determine the differences in aldosterone during an orthostatic tilt without stimulation and with optimal stimulation.	through study completion, an average of 2 years