Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Orthostatic Hypotension Clinical Trial

Official title:

Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960448
• Other study ID #: 1727500
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: August 2023
• Source: James J. Peters Veterans Affairs Medical Center
• Contact: Matthew T Maher, MS
• Phone: (718) 584-9000
• Email: Matthew.Maher[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are:

• What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI?

• What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS.

Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study.

Please note that there no expected long term benefits of this study.

Description:

The purpose of the first part of this research study is to determine the effects of active transcutaneous spinal cord stimulation (TSCS) targeted for blood pressure (BP) control on exercise endurance time and heart rate (HR) recovery time during an arm cycle test. The results will help guide experimental studies aimed at improving exercise, rehabilitation, health, and longevity in the SCI population. If the participant chooses to participate in part one of this study, the participant will be asked to visit the laboratory for 2 visits that take about 3-4 hours each.

The purpose of part two of this study is to compare the effects of electricity being delivered through surface electrodes (sticky pads on the participants skin), called active transcutaneous spinal cord stimulation (TSCS), compared to sham TSCS (sticky pads with electricity initially turned on but then turned off) on the participants ability to 1) keep the participants body temperature stable and 2) feel comfortable, while in a cool environment (cool room at 64° F) for 90 minutes. The investigators will assess the participant thermal sensation by asking the participant if overall they feel cold, cool, neutral, warm, or hot and their comfort level by asking the participant to grade their thermal comfort (how comfortable or how uncomfortable they feel) when the participant is seated in a thermoneutral room (80° F) and again in the cool room with active TSCS compared to the cool room with sham TSCS. The results will help guide experimental studies aimed at improving health and longevity in the population with SCI. If the participant chooses to participate in this study, there will be 2 study visits that last about 3-4 hours each.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• You are above the age of 18 years old

• You have an SCI between C3-T6

• You have been injured longer than 1 year

• You participated in a prior experiment "Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury"

• You have an American Spinal Injury Association injury classification scale (AIS) A, B, C

• Your prescription medications have not changed for at least 30 days

Exclusion Criteria:

• You have a history of seizures

• You have an acute illness or infection

• You have diabetes

• You have untreated thyroid disease

• You have a neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.)

• You have a history of heart or vascular disease (coronary artery disease, congestive heart failure, peripheral artery disease,)

• You have a history of moderate or severe head trauma (TBI) or diagnosed with cognitive impairment

• You have a present or history of a psychological disorder

• You have contraindications to electricity over your spine

• You are dependent on a ventilator to breathe or have an open tracheostomy site

• You have a recent history of substance abuse (within the past 3 months)

• You have open wounds over the spine at the level targeted for stimulation

• You are pregnant

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Spinal Cord Injuries

Intervention

Other:
• Transcutaneous Spinal Cord Stimulation (TSCS)
This is electrical stimulation delivered to the spinal cord through the skin and tissue using a cathode electrode to deliver the stimulation and anode electrodes to ground the circuit.
• Sham Transcutaneous Spinal Cord Stimulation
This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.

Locations

Country	Name	City	State
United States	James J Peters VAMC	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
James J. Peters Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Endurance Time	Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.	During procedures (30 minutes)
Primary	Recovery Heart Rate	Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.	During procedures (60 minutes)
Primary	Tcore	This outcome measure is measured in degrees Celsius.	During procedures (90 minutes)
Primary	Thermal Comfort	Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).	During procedures (90 minutes)
Secondary	Workload	This outcome is measured in Watts (highest watt obtained)	End of exercise (30 minutes)
Secondary	Rate of Perceived Exhaustion	This is measured on the Borg scale (06-20) higher number = harder perceived exertion	End of exercise (30 minutes)