Central Nervous System Diseases, Cough, Paralysis, Spinal Cord Diseases, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injuries
Conditions
Keywords
spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury
Brief summary
The purpose of this trial is to determine the efficacy of spinal cord stimulation to produce an effective cough in patients with spinal cord injuries.
Detailed 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. 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 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 18 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation of medical history, a brief physical examination, and initial testing, participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough.
Interventions
PROCEDURESpinal Cord Stimulation to restore cough
Participants will have small electrodes (metal discs) placed - by a routine surgical procedure - over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are then activated at subsequent study visits using the external control unit.
The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords 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.
Sponsors
MetroHealth Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. | baseline (pre-implant) and 1 year follow up (post-implant) | Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant). |
| Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough. | baseline (pre-implant) and 1 year follow up (post-implant) | Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incident of Acute Respiratory Tract Infections | baseline (pre-implant) and 1 year follow up (post-implant) | 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 over the 2-year period prior to 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. After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually. |
| Trained Caregiver Support for Secretion Clearance | baseline (pre-implant) and 1 year follow up (post-implant) | The degree of caregiver support was determined as the number of times it was necessary for a caregiver to provide the subject with any form of assistive means of secretion clearance including suctioning, manually assisted cough or use of the insufflation-exsufflation device. Caregiver support was evaluated over a 2-week period prior to implantation of the cough stimulation system and continuously over the course of the initial year and again at the 1-year follow-up. |
Countries
United States
Participant flow
Recruitment details
Subjects were well informed of the details of the study, with particular interest to risks/benefits, and asked to review the Informed Consent before signing.They were given an opportunity to ask questions. Consent was obtained only after all questions and concerns have been addressed.
Participants by arm
| Arm | Count |
|---|---|
| Clinical Trial - Spinal Cord Stimulation Cough System Design: Clinical trial.
Participants: Subjects with cervical spinal cord injury and weak cough.
Interventions: A fully implantable electrical stimulation system was surgically placed in each subject. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Clinical Trial - Spinal Cord Stimulation Cough System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Race/Ethnicity, Customized Black or African American | 2 participants |
| Race/Ethnicity, Customized Caucasian | 15 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 3 / 17 |
| serious Total, serious adverse events | 1 / 17 |
Outcome results
Primary
Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough.
Peak airflow achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Population: Male - 14; Female - 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Implant - Spontaneous Effort | Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough. | 1.9 L/s | Standard Error 0.2 |
| Post-Implantation - Spinal Cord Stimulation (SCS) | Effectiveness of Expiratory Muscle Activation to Generate High Peak Airflows Characteristic of Normal Cough. | 7.7 L/s | Standard Error 0.9 |
Primary
Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough.
Airway pressure generation achieved with SCS cough system at the baseline (pre-implant) and 1 year follow up (post-implant).
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Population: Male - 14; Female - 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Implant - Spontaneous Effort | Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. | 25 cmH2O | Standard Error 3 |
| Post-Implantation - Spinal Cord Stimulation (SCS) | Effectiveness of Expiratory Muscle Activation to Generate Large Airway Pressures Characteristic of Normal Cough. | 121 cmH2O | Standard Error 14 |
Comparison: Each patient was served as their own control; comparisons was made at various points in the study. Clinical parameters was assessed before the study and also at several end points following the Reconditioning Phase.p-value: <0.05ANOVA
Secondary
Incident of Acute 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 over the 2-year period prior to 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. After implantation of the cough system, the incidence of acute respiratory tract infections was tracked continually.
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Population: Male - 14; Female - 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Implant - Spontaneous Effort | Incident of Acute Respiratory Tract Infections | 1.31 Intections per year | Standard Error 0.32 |
| Post-Implantation - Spinal Cord Stimulation (SCS) | Incident of Acute Respiratory Tract Infections | 0.29 Intections per year | Standard Error 0.11 |
Comparison: The data prior to implantation were compared with data obtained after implantation of the cough system using a nonparametric analog (Freidman Test) to the standard repeated measures analysis of variance. Statistical significance was assumed at P\<0.05. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ± SEs.p-value: <0.05nonparametric analog (Freidman Test)
Secondary
Trained Caregiver Support for Secretion Clearance
The degree of caregiver support was determined as the number of times it was necessary for a caregiver to provide the subject with any form of assistive means of secretion clearance including suctioning, manually assisted cough or use of the insufflation-exsufflation device. Caregiver support was evaluated over a 2-week period prior to implantation of the cough stimulation system and continuously over the course of the initial year and again at the 1-year follow-up.
Time frame: baseline (pre-implant) and 1 year follow up (post-implant)
Population: Male - 14; Female - 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-Implant - Spontaneous Effort | Trained Caregiver Support for Secretion Clearance | 23.4 times/week | Standard Error 7.3 |
| Post-Implantation - Spinal Cord Stimulation (SCS) | Trained Caregiver Support for Secretion Clearance | 7.7 times/week | Standard Error 4.1 |