Stimulation With Wire Leads to Restore Cough

MetroHealth Medical Center

Status: Completed

Conditions: Spinal Cord Injuries; Trauma, Nervous System; Cough; Central Nervous System Diseases; Spinal Cord Diseases; Wounds and Injuries; Paralysis

Treatments: Procedure: Implantation of device; Device: Expiratory muscle stimulator

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01659541

IRB 15-00014

U01NS083696 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this trial is to determine the efficacy of spinal cord stimulation, using wire leads, to produce an effective cough in patients with spinal cord injuries.

Full description

Patients with cervical 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. Expiratory muscles can be activated by electrical stimulation of the spinal roots to produce a functionally effective cough.

The purpose of this trial is to determine if electrical stimulation of the expiratory muscles by wire leads is capable of producing an effective cough on demand. According to the trial researchers, if successful, this technique will prevent the need for frequent patient suctioning - which often requires the constant presence of trained personnel. It will also allow spinal cord injured patients to clear their secretions more readily, thereby reducing the incidence of respiratory complications and associated illness and death.

In the trial, researchers will study 16 adults (18-75 years old) with cervical spinal injuries (C8 level or higher), at least 6 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have wire leads placed - by a routine, minimally invasive surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spinal cord injury C8 level or higher
• 12 months post-injury (if the American Spinal Injury Association (ASIA) Impairment Scale (AIS) incomplete) or 6 months post-injury (if AIS complete)
• Expiratory muscle weakness
• Between 18 and 75 years of age
• Adequate oxygenation

Exclusion criteria

• Untreated lung, cardiovascular or brain disease
• Scoliosis, chest wall deformity, or marked obesity
• Unmanaged hypertension (high blood pressure) or hypotension (low blood pressure)
• Low oxygenation
• Minor infection at the site of implantation requiring antibiotics within the past 3 weeks
• Serious infection requiring hospitalization within the past 6 weeks

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Procedure & Device

Experimental group

Description:

Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator

Treatment:

Device: Expiratory muscle stimulator

Procedure: Implantation of device