Autonomic Effects of Stimulation in SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2026-07-30

Brief Summary

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This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output 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.

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Detailed Description

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This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise power output 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. Study 1 (arm cycle ergometry) will consist of 2 visits that will be between 2-3 hours in duration, separated by no less than 3 days, and will consist 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. Study 2 (cool environment) will consist of 2 visits that will be between 3-4 hours in duration, separated by no less than 3 days, and will consist of assessing core temperature when in a cool environment with the stimulator on and off.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

During both Study 1 and Study 2, the participants will be blinded to the order of completing the study with and without stimulation.

Study Groups

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Without stimulation

For study 1, exercise power output 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.

Group Type SHAM_COMPARATOR

Arm Ergometry

Intervention Type OTHER

Study 1 will use the arm ergometry as a form of exercise.

Cool Environment

Intervention Type OTHER

Study 2 will be completed in a cool environment setting.

With stimulation

For study 1, exercise power output 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.

Group Type ACTIVE_COMPARATOR

DS8R

Intervention Type DEVICE

transcutaneous stimulation of the spinal cord.

Arm Ergometry

Intervention Type OTHER

Study 1 will use the arm ergometry as a form of exercise.

Cool Environment

Intervention Type OTHER

Study 2 will be completed in a cool environment setting.

Interventions

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DS8R

transcutaneous stimulation of the spinal cord.

Intervention Type DEVICE

Arm Ergometry

Study 1 will use the arm ergometry as a form of exercise.

Intervention Type OTHER

Cool Environment

Study 2 will be completed in a cool environment setting.

Intervention Type OTHER

Other Intervention Names

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Transcutaneous Stimulation Arm cycling

Eligibility Criteria

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Inclusion Criteria

* injury more than 1 year ago, non-ambulatory
* level of lesion C3-T6, AIS A, B, or C
* 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 (L1/L2) and pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No