Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05960448

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

Led by James J. Peters Veterans Affairs Medical Center · Updated on 2024-10-01

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of transcutaneous spinal cord stimulation (TSCS) on exercise ability and core body temperature regulation in people with chronic spinal cord injury (SCI). This interventional crossover study aims to compare active TSCS targeting blood pressure control with sham TSCS. The study focuses on exercise endurance during arm cycling and heart rate recovery, as well as body temperature responses and comfort in a cool environment. Participants receive both active and sham TSCS delivered through surface electrodes placed on the skin, with stimulation parameters tailored to each individual. The active stimulation lasts 30 minutes, while sham stimulation is applied for only one minute to simulate the experience without therapeutic effect. The study has two parts: one involving arm cycling exercise and another involving exposure to a cool room at 64°F for 90 minutes. Participants may choose to join one or both parts. During the study visits, participants undergo exercise tests and remain seated in controlled temperature rooms while their responses to stimulation are recorded. Assessments include exercise endurance time, heart rate recovery, core body temperature, and thermal comfort ratings. Each part involves two laboratory visits lasting 3-4 hours each. The researchers also measure workload and perceived exhaustion after exercise. The total participation time depends on the parts chosen. There are no expected long-term benefits from participation.

CONDITIONS

Brief Title

Autonomic Effects of Spinal Cord Stimulation in Spinal Cord Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • You are above the age of 18 years old
  • You have a spinal cord injury between C3 and 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, or C
  • Your prescription medications have not changed for at least 30 days
Not Eligible

You will not qualify if you...

  • 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 spinal cord injury (such as Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease)
  • You have a history of heart or vascular disease (including coronary artery disease, congestive heart failure, peripheral artery disease)
  • You have a history of moderate or severe head trauma or 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 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 targeted stimulation level
  • You are pregnant

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - Two visits lasting about 3 to 4 hours each

Participants receive transcutaneous spinal cord stimulation (TSCS) or sham TSCS to assess effects on blood pressure control, exercise endurance, heart rate recovery, body temperature stability, and thermal comfort.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

James J Peters VAMC

The Bronx, New York, United States, 10468

Actively Recruiting

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Research Team

M

Matthew T Maher, MS

F

Fiona E Fox, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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