Health TrialsbyHealthPanel

Abdominal Stimulation to Improve Cough After Spinal Cord Injury

ConditionsSpinal Cord Injuries (SCI)Respiratory Insufficiency
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorLiberate Medical

About this trial

The goal of this clinical trial is to learn if abdominal functional electrical stimulation (FES) using the VentFree Respiratory Muscle Stimulator improves cough strength in adults with a new spinal cord injury (SCI). It will also learn about the safety of abdominal FES in this population. The main questions it aims to answer are:

Does abdominal FES improve cough peak flow (a measure of cough strength) compared to cough training alone? Does abdominal FES reduce the number of respiratory complications (such as pneumonia or atelectasis)? What medical problems do participants have when receiving abdominal FES?

Researchers will compare abdominal FES (active treatment) to supervised cough training without stimulation (control) to see if abdominal FES improves cough function after spinal cord injury.

Participants will:

Receive abdominal FES or perform supervised cough training 5 days per week for up to 6 weeks during inpatient rehabilitation Have cough strength and breathing function measured at the start of the study and every week during treatment Complete quality of life and bowel function questionnaires at multiple time points Have a follow-up visit or phone call 4 weeks after completing treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥ 22 years of age) admitted to rehabilitation with a new SCI.

New non-progressive SCI occurring in the past 3 to 8 weeks.

Neurological level of injury of C1-T5.

American Spinal Injuries Association Impairment Scale A to C.

Disqualifiers

Respiratory complications in previous 24 hours (screening out iatrogenic complications).

Chronic respiratory disease.

No contraction of the abdominal wall muscles in response to abdominal NMES.

Open abdominal surgery ≤ 4 weeks prior to enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Respiratory Muscle Stimulator

    Device

    Transcutaneous neuromuscular electrical stimulation (NMES) device that applies abdominal functional electrical stimulation (FES) to the abdominal wall muscles in synchrony with the expiratory phase of breathing. The device consists of a control unit, nasal-oral cannula (used to detect breathing phase), disposable transcutaneous stimulation electrodes, and power supply. Electrodes are placed posterolaterally to activate the transversus abdominis and internal and external oblique muscles. Stimulation parameters are 30 Hz / 350 µs during quiet breathing and 50 Hz / 400 µs during coughing. Stimulation amplitude is titrated per session to achieve a strong visible abdominal wall contraction without discomfort, expected to be between 50 mA and 100 mA. Stimulation electrodes and nasal-oral cannula are replaced every five days of treatment.

  • Supervised Cough Training

    Behavioral

    Supervised volitional cough training performed without any active stimulation or device assistance. Participants perform 3 sets of 10 coughs per day with approximately 7 seconds between each cough and 3 to 5 minutes between sets, delivered by a trained research team member at the participant's bedside with the participant sitting upright.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Abdominal Functional Electrical Stimulation (Active Treatment)Experimental treatment 1 intervention
Group B: Supervised Cough Training (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cough Peak Flow (CPF)

Cough peak flow measured in liters per minute (L/min) using the PneumotracTM (Vitalograph; Lenexa, KS) bedside respiratory muscle strength system, following European Respiratory Society (ERS) guidelines. Measurements are recorded with the participant seated upright in a chair/wheelchair or at 90 degrees in bed, breathing through a mouthpiece or tracheostomy valve piece with a nose clip in place. The participant is instructed to breathe in deeply to total lung capacity then cough as hard as possible. The test is performed 3 times and the greatest value is used for analysis. A CPF of less than 160 L/min indicates an ineffective cough, and a CPF of less than 270 L/min has been shown to be associated with decreased secretion clearance and increased respiratory complications in spinal cord injury.

Time frame
baseline and weekly post randomization for 6 weeks or until hospital discharge, whatever comes first.

Secondary outcomes

1

Effectiveness of Cough

Proportion of participants achieving a cough peak flow greater than 160 L/min, measured using the PneumotracTM (Vitalograph; Lenexa, KS), indicating attainment of an effective cough threshold.

Time frame
At 6 weeks or hospital discharge, whatever comes first
2

Number of Participants with Respiratory Complications

roportion of participants sustaining a respiratory complication, defined as meeting 2 out of 3 of the following criteria: symptoms and signs suggestive of infection; respiratory symptoms or signs consistent with acute respiratory infection; chest X-ray infiltrates if available; AND receiving therapy for respiratory infection. Includes atelectasis, pneumonia, pleural effusion, and respiratory failure requiring mechanical ventilation. Extracted from medical records during treatment and through participant self-reporting at follow-up.

Time frame
From enrollment to the end of the 4 week follow-up visit
3

Forced Vital Capacity (FVC)

Forced vital capacity measured in liters using the PneumotracTM (Vitalograph; Lenexa, KS) with the participant seated upright, following ATS/ERS guidelines. Three reproducible maneuvers within 10% of each other are required and the greatest value is used for analysis.

Time frame
At 6 weeks or hospital discharge, whatever comes first
4

Forced Expiratory Volume in One Second (FEV1)

Forced expiratory volume in one second measured in liters using the PneumotracTM (Vitalograph; Lenexa, KS) with the participant seated upright, following ATS/ERS guidelines. Three reproducible maneuvers within 10% of each other are required and the greatest value is used for analysis.

Time frame
At 6 weeks or hospital discharge, whatever comes first

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Liberate Medical

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

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