Abdominal Stimulation to Improve Cough After Spinal Cord Injury

NCT07626931 | Not Yet Recruiting FDA Device

• 2 other identifiers: LM-SCI-P1HT9425-25-1-0187
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Spinal Cord Injuries (SCI); Respiratory Insufficiency

Keywords

Spinal Cord Injuries; Functional Electrical Stimulation; Cough Peak Flow; Respiratory Muscles; Abdominal Muscles; Tetraplegia; Rehabilitation; Muscle Strength

Outcome Measures

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.

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

Secondary Outcomes (11)

• Effectiveness of Cough

  At 6 weeks or hospital discharge, whatever comes first

• Number of Participants with Respiratory Complications

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

• Forced Vital Capacity (FVC)

  At 6 weeks or hospital discharge, whatever comes first

• Forced Expiratory Volume in One Second (FEV1)

  At 6 weeks or hospital discharge, whatever comes first

• Peak Expiratory Flow (PEF)

  At 6 weeks or hospital discharge, whatever comes first

Study Arms (2)

Abdominal Functional Electrical Stimulation (Active Treatment)

EXPERIMENTAL

Participants receive abdominal FES using the VentFree Respiratory Muscle Stimulator 5 days per week for up to 6 weeks or until hospital discharge, whichever comes first. Abdominal FES is applied during 3 sets of 10 coughs (approximately 7 seconds between each cough, 3 to 5 minutes between sets) followed by 30 minutes of quiet breathing. Stimulation is delivered at 30 Hz / 350 µs during quiet breathing and 50 Hz / 400 µs during coughing, with amplitude titrated to achieve a strong visible abdominal wall contraction without discomfort. Treatment is delivered at the participant's bedside with the participant sitting upright. Active treatment is applied as an adjunct to standard of care.

Device: Respiratory Muscle Stimulator

Supervised Cough Training (Control)

ACTIVE COMPARATOR

Participants perform 3 sets of 10 supervised volitional coughs per day (approximately 7 seconds between each cough, 3 to 5 minutes between sets), 5 days per week for up to 6 weeks or until hospital discharge, whichever comes first. No active stimulation is applied. Training is delivered at the participant's bedside with the participant sitting upright. Control treatment is applied as an adjunct to standard of care.

Behavioral: Supervised Cough Training

Interventions

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.

Abdominal Functional Electrical Stimulation (Active 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.

Supervised Cough Training (Control)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• CPF of \<160 L/min (Note: A CPF of \<270 L/min has been shown to be associated with decreased secretion clearance and increased respiratory complications, while a CPF of \<160 L/min has been shown to lead to an ineffective cough).
• Not dependent on mechanical ventilation (people dependent on mechanical ventilation are at greatly increased risk of respiratory complications and are excluded due to this heterogeneity).
• Able to sit upright.
• Expected to remain in rehabilitation for at least another 3 weeks.

You may not qualify if:

• 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.
• Have yet to undergo spinal surgery to stabilize injury, where required.
• Body mass index \>40 kg/m2.
• Pacemaker (external or internal) or implanted electronic device (e.g., a defibrillator).
• Known or expected to be pregnant.
• Placed on a palliative/supportive care only pathway.
• Receiving any of the following as standard of care:
• Abdominal FES
• Inspiratory or Expiratory muscle training
• Transcutaneous or implanted thoracolumbar spinal stimulation
• Participating in any of the following:
• A study with the same or similar primary endpoint

Sponsors & Collaborators

• Liberate Medical: lead
• United States Department of Defense: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries; Respiratory Insufficiency; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angus Mclachlan, PhD

  Liberate Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director of Clinical Operations

CONTACT

833-203-4663; senen@liberatemedical.com

Head of Clinical Affairs

CONTACT

833-203-4663; christopher@liberatemedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share