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Autonomic Effects of Stimulation in SCI

Primary Purpose

Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DS8R
Arm Ergometry
Cool Environment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Orthostatic Hypotension, Exercise, Hypotension, Body Core Temperature, Blood Pressure

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: injury more than 1 year ago, non-ambulatory level of lesion C3-T1, AIS A or B stable prescription medication regimen for at least 30 days must be able to commit to study requirements of 7 visits within a 60-day period Exclusion Criteria: extensive history of seizures ventilator dependence or patent tracheostomy site history of neurologic disorder other than SCI history of moderate or severe head trauma contraindications to spine stimulation significant cardiovascular disease active psychological disorder recent history (within 3 months) of substance abuse open skin lesions over spine at levels targeted for stimulation (T7/8, T11/12) and pregnancy

Sites / Locations

  • James J. Peters VA Medical Center, Bronx, NYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Without stimulation

With stimulation

Arm Description

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation.

For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation.

Outcomes

Primary Outcome Measures

Electrode placement
Electrodes will be placed on the vertebral midline at the spinous process (T7/T8, T11/12). Determine the best electrode placement on the spine that increases blood pressure to around 120/80 mmHg in the seated position.
Amplitude of TSCS
Amplitude of the stimulation will start at 5mA and increase in increments of 5mA to determine the best amplitude to normalize blood pressure. The same spinous process sites (T7/T8, T11/12) will be used. The best amplitude will be used to increase blood pressure during Study 1 (arm ergometry) and Study 2 (cool environment).

Secondary Outcome Measures

Exercise Endurance Time
Determine if TSCS increases exercise endurance time compared to no stimulation.
Heart Rate Recovery Time
Determine if TSCS shortens the amount of time for HR recovery (return to baseline) compared to no stimulation.
Body Core Temperature
Determine if TSCS helps maintain body core temperature in a cool environment compared to no stimulation.
Subjective Reporting on Thermal Comfort and Thermal Sensation
To determine if TSCS helps improve subjective reporting on thermal comfort and thermal sensation compared to no stimulation.

Full Information

First Posted
December 15, 2022
Last Updated
July 26, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05664646
Brief Title
Autonomic Effects of Stimulation in SCI
Official Title
Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
July 30, 2026 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.
Detailed Description
This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment. The study will consist of 7 visits, that will be between 3-4 hours in duration, separated by no less than 3 days. Visit 1 will consist of determining baseline autonomic function and screening visit. The participant will undergo a sit up set to determine hypotension and orthostatic hypotension and complete a couple surveys. Visits 2 and 3 will determine which site the stimulation parameters should be on the spine, either T7-T8 or T11-12. The site that increases seated systolic blood pressure will be used for the rest of the study. Visits 4 and 5 will consists of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. Visits 6 and 7 will consist of assessing core temperature when in a cool environment with the stimulator on and off.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Orthostatic Hypotension, Exercise, Hypotension, Body Core Temperature, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will complete an orthostatic tilt without stimulation, then go through transcutaneous stimulation mapping sessions to determine the optimal parameters. During the study 1 visits, the participants will complete an arm ergometry exercise with the optimal stimulation parameters and without (sham). During study 2 visits, the participants' body core temperature will be measured about being exposed to a cool environment with stimulation and without (sham).
Masking
Participant
Masking Description
The visits during Study 1 (4&5) and Study 2 (6&7), the participants will be blinded to the order of completing the study with and without stimulation.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without stimulation
Arm Type
Sham Comparator
Arm Description
For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation.
Arm Title
With stimulation
Arm Type
Active Comparator
Arm Description
For study 1, exercise endurance time and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation.
Intervention Type
Device
Intervention Name(s)
DS8R
Other Intervention Name(s)
Transcutaneous Stimulation
Intervention Description
transcutaneous stimulation of the spinal cord.
Intervention Type
Other
Intervention Name(s)
Arm Ergometry
Other Intervention Name(s)
Arm cycling
Intervention Description
Study 1 will use the arm ergometry as a form of exercise.
Intervention Type
Other
Intervention Name(s)
Cool Environment
Intervention Description
Study 2 will be completed in a cool environment setting.
Primary Outcome Measure Information:
Title
Electrode placement
Description
Electrodes will be placed on the vertebral midline at the spinous process (T7/T8, T11/12). Determine the best electrode placement on the spine that increases blood pressure to around 120/80 mmHg in the seated position.
Time Frame
through study completion, up to 2 years
Title
Amplitude of TSCS
Description
Amplitude of the stimulation will start at 5mA and increase in increments of 5mA to determine the best amplitude to normalize blood pressure. The same spinous process sites (T7/T8, T11/12) will be used. The best amplitude will be used to increase blood pressure during Study 1 (arm ergometry) and Study 2 (cool environment).
Time Frame
through study completion, up to 2 years
Secondary Outcome Measure Information:
Title
Exercise Endurance Time
Description
Determine if TSCS increases exercise endurance time compared to no stimulation.
Time Frame
through study completion, up to 2 years
Title
Heart Rate Recovery Time
Description
Determine if TSCS shortens the amount of time for HR recovery (return to baseline) compared to no stimulation.
Time Frame
through study completion, up to 2 years
Title
Body Core Temperature
Description
Determine if TSCS helps maintain body core temperature in a cool environment compared to no stimulation.
Time Frame
through study completion, up to 2 years
Title
Subjective Reporting on Thermal Comfort and Thermal Sensation
Description
To determine if TSCS helps improve subjective reporting on thermal comfort and thermal sensation compared to no stimulation.
Time Frame
through study completion, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: injury more than 1 year ago, non-ambulatory level of lesion C3-T1, AIS A or B stable prescription medication regimen for at least 30 days must be able to commit to study requirements of 7 visits within a 60-day period Exclusion Criteria: extensive history of seizures ventilator dependence or patent tracheostomy site history of neurologic disorder other than SCI history of moderate or severe head trauma contraindications to spine stimulation significant cardiovascular disease active psychological disorder recent history (within 3 months) of substance abuse open skin lesions over spine at levels targeted for stimulation (T7/8, T11/12) and pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Wecht, EdD
Phone
(718) 584-9000
Ext
3122
Email
jm.wecht@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew T Maher, MS
Phone
(718) 584-9000
Ext
1732
Email
matthew.maher@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Wecht, EdD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468-3904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Wecht, EdD
Phone
718-584-9000
Ext
3122
Email
jm.wecht@va.gov
First Name & Middle Initial & Last Name & Degree
Matthew T Maher, MS
Phone
(718) 584-9000
Ext
1732
Email
matthew.maher@va.gov
First Name & Middle Initial & Last Name & Degree
Jill Wecht, EdD

12. IPD Sharing Statement

Plan to Share IPD
No

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Autonomic Effects of Stimulation in SCI

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