Recruiting

Electrical Stimulation & Training

Sponsor:

University of Miami

Code:

NCT05745298

Conditions

Acute Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Xcite Clinical Station

Study Details

Brief summary:

The overall objective of this study is to improve unaided cough with abdominal and latissimus dorsi functional electrical stimulation in conjunction with respiratory muscle training in individuals with acute spinal cord injuries.

Conditions

Acute Spinal Cord Injury

Study ID

NCT05745298

Start date

Jul 21, 2023

Status verified date

Jul, 2026

Completion date

Sep 21, 2028

Anticipated

Primary completion date

Jul 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Traumatic and atraumatic C2- T12 Spinal cord injury (AIS A, B, and C motor incomplete and complete injuries) currently admitted to inpatient rehabilitation with an injury date < 12 months prior to enrollment
2. Positive response to electrical stimulation through a palpable contraction
3. Fluent in written and spoken English

Exclusion Criteria:

1. Individuals who do not meet inclusion criteria
2. Prisoners
3. Concurrent traumatic brain injury determined by Rancho level of cognitive functioning < VI
4. Individuals with open tracheostomy
5. Persons with pacemakers
6. Pregnant women
7. Persons with epilepsy
8. Open wounds or metal implants at site of electrode placement
9. Unresponsive to functional electrical stimulation
10. Current diagnosis or history of thoraco-abdomino-pelvic cancer

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AFES and RMT Paraplegia Group

Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.

experimental: AFES and RMT Tetraplegia Group

Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.

Interventions

Xcite Clinical Station

The abdominal functional electrical stimulation (AFES) will be conducted using the Xcite system. This is a battery-powered stimulator with up to 12 channels of cyclical stimulation. It is a task-specific modality to enhance mass practice during neurological re-education. The electrical stimulation will be applied to the abdominal and back muscles. In addition, participants will receive two specific respiratory muscle training exercises performed 3 days per week.

Primary outcome measure

  • Percentage change in peak cough flow (PCF) [ Time Frame: one week pre-intervention and up to 4 weeks post-intervention ]
  • Percentage change in peak expiratory flow [ Time Frame: one week pre-intervention and up to 4 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Gary J Farkas, PhD

305-243-4518gjf50@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Gary J Farkas, PhD

3052434518gjf50@med.miami.edu

Principal Investigator:

Stephane stephane.philippera@jhsmiami.org

More Information

Sponsor

University of Miami

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-17.