Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury

Summary

The goal of this clinical trial is to determine whether people with paralysis due to a spinal cord injury can benefit from breathing short intermittent bouts of air with low oxygen (O2) combined with slightly higher levels of carbon dioxide (CO2), interspaced by breathing room air. The technical name for this therapeutic air mixture is 'acute intermittent hypercapnic-hypoxia,' abbreviated as AIHH. Following exposure to the gas mixture, participants will receive non-invasive electrical stimulation to the spinal cord paired with specific and targeted exercise training.

The main question this trial aims to answer is: Can the therapeutic application of AIHH, combined with non-invasive electrical stimulation to the spinal cord plus exercise training, increase the strength of muscles involved in breathing and hand function in people with paralysis due to a spinal cord injury?

Participants will be asked to attend a minimum of five study visits, each separated by at least a week. During these visits, participants will be required to:

* Answer basic questions about their health
* Receive exposure to the therapeutic air mixture (AIHH)
* Undergo non-invasive spinal electrical stimulation
* Complete functional breathing and arm strength testing
* Undergo a single blood draw
* Provide a saliva sample

Researchers will compare the results of individuals without a spinal cord injury to those of individuals with a spinal cord injury to determine if the effects are similar.

Conditions

• Cervical Spinal Cord Injury

Interventions

OTHER

Acute Intermittent Hypercapnic Hypoxia

15 x \[1 min 9% O2, 4% CO2, and balance N2, followed by 1.5 min normoxia\];

OTHER

Transcutaneous spinal cord stimulation

Open-loop, continuous, high-frequency electrical stimulation at 150 Hz with a tolerable current amplitude of \~25-35 mA and a pulse width of 400 µsec, using a biphasic symmetric waveform. Paired with Respiratory Resistance Training and Hand Grip Strength Training.

OTHER

SHAM Acute Intermittent Hypercapnic Hypoxia

Normoxia for the amount of time AIHH is delivered.

OTHER

SHAM Transcutaneous spinal cord stimulation

Open-loop, continuous, high-frequency electrical stimulation at 150 Hz with a tolerable current amplitude of 0mA and a pulse width of 400 µsec,using a biphasic symmetric waveform. Paired with Respiratory Resistance Training and Hand Grip Strength Training.

Sponsors & Collaborators

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• Justine Dee, PT · Thomas Jefferson University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-16

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• United States

Study Locations