Sub-study to Spinal Cord Stimulation to Restore Cough

MetroHealth Medical Center

Status: Completed

Conditions: Spinal Cord Injuries; Cough; Central Nervous System Diseases; Spinal Cord Diseases; Paralysis

Treatments: Procedure: Spinal Cord Stimulation; Device: Expiratory Muscle Stimulator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00995215

IRB08-00269 (Other Identifier)

IRB08-00269/IRB98-00091

IRB98-00091

Details and patient eligibility

About

Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough

Full description

Patients with cervical and thoracic spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. In fact, pneumonia is a major cause of death in this patient population.

In a recent clinical trial, we have shown that the expiratory muscles can be electrically activated by spinal cord stimulation (SCS), a technique which involves the surgical placement of disc electrodes on the surface of the spinal cord. This method is successful in achieving an effective means of expiratory muscle activation, as demonstrated by the generation of large airway pressures and peak airflow rates. Importantly, SCS facilitates secretion removal, reduces the need for caregiver support, reduces the incidence of respiratory tract infections and improves life quality. This method therefore has the potential to reduce health care costs and improve survival in spinal cord injured subjects.

The purpose of this trial is to directly compare activation of the expiratory muscles using wire electrodes, which can be inserted percutaneously through a needle, with the previously employed disc electrodes.

In this trial, researchers will study 6 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation including medical history, a brief physical examination, and initial testing, each participant will undergo a surgical procedure to implant small electrodes (metal discs) over the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. Prior to permanent implantation of this system, wire and disc electrodes will be compared by assessing the degree of expiratory muscle activation with each electrode type. The disc electrodes will then be permanently implanted, allowing the participant to have use of a fully functioning stimulation system to restore an effective cough.

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stable spinal cord injury T5 level or higher
• Expiratory muscle weakness

Exclusion criteria

• Significant cardiovascular disease
• Active lung disease
• Brain disease
• Scoliosis, chest wall deformity, or marked obesity

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Spinal Cord Stimulation

Experimental group

Description:

The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.

Treatment:

Procedure: Spinal Cord Stimulation

Device: Expiratory Muscle Stimulator