Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJames J. Peters Veterans Affairs Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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"

Disqualifiers

You have a history of seizures

You have an acute illness or infection

You have diabetes

You have untreated thyroid disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Transcutaneous Spinal Cord Stimulation (TSCS)

    Other intervention

    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

    Other intervention

    This is designed to appear like transcutaneous spinal cord stimulation without actually delivering the stimulation.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Transcutaneous Spinal Cord StimulationExperimental treatment 1 intervention
Group B: Sham Transcutaneous Spinal Cord StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise Endurance Time

Total time (minutes) the participant is able to exercise during the submaximal arm cycle ergometry test.

Time frame
During procedures (30 minutes)
2

Recovery Heart Rate

Total time (minutes) for heart rate to return to baseline levels after submaximal exertion.

Time frame
During procedures (60 minutes)
3

Tcore

This outcome measure is measured in degrees Celsius.

Time frame
During procedures (90 minutes)
4

Thermal Comfort

Feeling of comfort from: +3 (very comfortable) to -3 (very uncomfortable).

Time frame
During procedures (90 minutes)

Secondary outcomes

1

Workload

This outcome is measured in Watts (highest watt obtained)

Time frame
End of exercise (30 minutes)
2

Rate of Perceived Exhaustion

This is measured on the Borg scale (06-20) higher number = harder perceived exertion

Time frame
End of exercise (30 minutes)

Other outcomes

Sponsors and contacts

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