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Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Primary Purpose

Orthostatic Hypotension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Spinal Cord Stimulation (TSCS)
Sham Transcutaneous Spinal Cord Stimulation
Sponsored by
James J. Peters Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthostatic Hypotension focused on measuring neuromodulation, stimulation, exercise, hand bike, thermoregulation, cold room

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James J Peters VAMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcutaneous Spinal Cord Stimulation

Sham Transcutaneous Spinal Cord Stimulation

Arm Description

The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.

The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.

Outcomes

Primary Outcome Measures

Exercise Endurance Time
Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.
Recovery Heart Rate
Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.
Tcore
This outcome measure is measured in degrees Celsius.
Thermal Comfort
Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).

Secondary Outcome Measures

Workload
This outcome is measured in Watts (highest watt obtained)
Rate of Perceived Exhaustion
This is measured on the Borg scale (06-20) higher number = harder perceived exertion

Full Information

First Posted
July 17, 2023
Last Updated
August 11, 2023
Sponsor
James J. Peters Veterans Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05960448
Brief Title
Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury
Official Title
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2023 (Actual)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
James J. Peters Veterans Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
neuromodulation, stimulation, exercise, hand bike, thermoregulation, cold room

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
The participant will not know whether or not they are receiving spinal stimulation at any given session
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.
Arm Title
Sham Transcutaneous Spinal Cord Stimulation
Arm Type
Sham Comparator
Arm Description
The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Spinal Cord Stimulation (TSCS)
Other Intervention Name(s)
transcutaneous spinal stimulation (TSS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Transcutaneous Spinal Cord Stimulation
Other Intervention Name(s)
Sham Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Stimulation, Placebo Transcutaneous Spinal Cord Stimulation
Intervention Description
This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.
Primary Outcome Measure Information:
Title
Exercise Endurance Time
Description
Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.
Time Frame
During procedures (30 minutes)
Title
Recovery Heart Rate
Description
Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.
Time Frame
During procedures (60 minutes)
Title
Tcore
Description
This outcome measure is measured in degrees Celsius.
Time Frame
During procedures (90 minutes)
Title
Thermal Comfort
Description
Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).
Time Frame
During procedures (90 minutes)
Secondary Outcome Measure Information:
Title
Workload
Description
This outcome is measured in Watts (highest watt obtained)
Time Frame
End of exercise (30 minutes)
Title
Rate of Perceived Exhaustion
Description
This is measured on the Borg scale (06-20) higher number = harder perceived exertion
Time Frame
End of exercise (30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew T Maher, MS
Phone
(718) 584-9000
Ext
1706
Email
Matthew.Maher@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona E Fox, BS
Phone
(718) 584-9000
Ext
3128
Email
fefox16@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill M Wecht, EdD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J Peters VAMC
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew T Maher, MS
Phone
718-584-9000
Ext
1706
Email
Matthew.Maher@va.gov
First Name & Middle Initial & Last Name & Degree
Jill M Wecht, EdD

12. IPD Sharing Statement

Plan to Share IPD
No

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Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

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