Have you or your loved ones been diagnosed with central nervous system diseases?

You may be eligible to participate in a central nervous system diseases clinical trial.

Have you or your loved ones been diagnosed with central nervous system diseases? You may be eligible to participate in a central nervous system diseases clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Central Nervous System Diseases Clinical Trial in Cleveland OH

NCT01659541 | Interventional

Have you or your loved ones been diagnosed with central nervous system diseases?

You may be eligible to participate in a central nervous system diseases clinical trial.

Have you or your loved ones been diagnosed with central nervous system diseases? You may be eligible to participate in a central nervous system diseases clinical trial.

Completed

Male & Female

18 - 75

Years old

This study has recruited 12 Participants

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.

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Details for the study

Brief Title

Stimulation With Wire Leads to Restore Cough

Official Title

Spinal Cord Stimulation With Wire Leads to Restore Cough

Brief Summary

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

Detailed 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.

Treatments and/or Procedures

Expiratory muscle stimulator

The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.

Implantation of device

The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box to stimulate the expiratory muscles and restore cough.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough

Maximum expiratory pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.

52 weeks (1 year)

Primary

Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough.

Peak Expiratory airflow rate is a person's maximum speed of expiration. Peak expiratory flow rate is the maximum flow rate generated during a forceful exhalation, starting from full inspiration. It was measured after release of airway occlusion after peak airway pressure was achieved.

52 weeks (1 year)

Secondary

Secretion Management Episodes

This assessment allowed to characterize the severity of secretion management episodes and subjective assessment of the need for secretion management before and after use of the Cough System. Design: Prospective assessment via questionnaire responses Question: How significant were your needs for assistance with managing your airway secretions on a typical day during the past week? 0 None - Unaware of need Mild - Did not interfere with usual daily activities Moderate - Most stop activity during need Marked - Most stop activity for brief period (10-30 min) after need Severe - Most stop activity for prolonged period (> 30 min) after need, may be accompanied by dizziness, headache and/or pain in upper chest

52 weeks (1 year)

Secondary

Difficulty Raising Sputum

Survey to assess difficulty raising sputum Objectives: To determine the difficulty raising sputum before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: How much difficulty have you had with managing your airway secretions? On a scale of 0-4 (0 = None (No secretions), 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty).

52 weeks (1 year)

Secondary

Number of Respiratory Tract Infections

Form covers frequency, type, severity, and antibiotic use for respiratory tract infections. The incidence of acute respiratory tract infections, defined by a change in the character, color, or amount of respiratory secretions and requiring antibiotic administration was tracked before and after implantation of the cough system. The occurrence of respiratory tract infections was determined by subject history and corroborated by review of medical records, when available.

52 weeks (1 year)

Secondary

Life Quality Assessment -Stress Level

Survey will assess the subject's quality of life at home and in social situations, as well as assess specific need for managing secretions. Objectives: Life Quality Assessment before and after use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did managing your airway secretions cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much)

52 weeks (1 year)

Study Criteria

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