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Stimulation With Wire Leads to Restore Cough

Sponsor
MetroHealth Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01659541
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
12
Enrollment
1
Location
1
Arm
76
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Expiratory muscle stimulator
  • Procedure: Implantation of device
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Spinal Cord Stimulation With Wire Leads to Restore Cough
Actual Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Procedure & Device

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

Device: 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.
Other Names:
  • Custom Finetech/Ardiem Sacral Anterior Root Stimulator

    • Procedure: 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

    Primary Outcome Measures

    1. Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough [2 years]

      Peak Expiratory Flow 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.

    2. Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough [2 years]

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

    Secondary Outcome Measures

    1. Assessment of Need for Caregiver Support for Secretion Management as Measured by a Caregiver Burden Inventory and Quality of Life Survey [2 years]

      The data prior to implantation (control) were compared with data obtained after implantation (Week #3, #7, #11, #15, #20, #24, #28, #40, #52,18-Mth and 24-Mth) of the cough system. Survey will assess time dependency, personal development, and physical, social, and emotional health of the caregiver, as well as assess specific need for caregiver's assistance in managing secretions. Objectives: To determine caregiver burden and quality of life of primary family caregivers before use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did providing assistance with managing the airway secretions of the person you care for cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much)

    2. Assessment of Ease in Expectoration of Secretions Using a Secretion Management Index [2 years]

      Survey will assess difficulty, frequency, and severity of subject's secretion management. Objectives: To determine the sputum index 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, 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty).

    3. Number of Respiratory Tract Infections Over the 2-year Period [2 years]

      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 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.

    4. Assessment of Quality of Life [2 years]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MetroHealth Medical Center Cleveland Ohio United States 44109

    Sponsors and Collaborators

    • MetroHealth Medical Center
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Anthony F. DiMarco, MD, MetroHealth Medical Center

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Anthony F. Dimarco, Professor, MetroHealth Medical Center
    ClinicalTrials.gov Identifier:
    NCT01659541
    Other Study ID Numbers:
    • IRB 15-00014
    • U01NS083696
    First Posted:
    Aug 8, 2012
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by Anthony F. Dimarco, Professor, MetroHealth Medical Center
    spinal cord injury
    paralysis
    cough
    cervical spinal cord injury
    thoracic spinal cord injury
    Additional relevant MeSH terms:
    Cough
    Spinal Cord Injuries
    Nervous System Diseases
    Paralysis
    Central Nervous System Diseases
    Spinal Cord Diseases
    Trauma, Nervous System
    Wounds and Injuries

    Study Results

    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.
    Pre-assignment Detail
    Arm/Group Title Spinal Cord Stimulation With Wire Leads to Restore Cough
    Arm/Group Description Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator 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.
    Period Title: Overall Study
    STARTED 12
    COMPLETED 11
    NOT COMPLETED 1

    Baseline Characteristics

    Arm/Group Title Clinical Trial: Spinal Cord Stimulation to Restore Cough
    Arm/Group Description Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator 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.
    Overall Participants 12
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    12
    100%
    >=65 years
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    12
    100%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    12
    100%
    Region of Enrollment (participants) [Number]
    United States
    12
    100%
    Pre-Implant - Spontaneous Effort - Airway Pressure (cmH2O) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cmH2O]
    26.2
    (14.6)

    Outcome Measures

    1. Primary Outcome
    Title Measurements of Peak Expiratory Airflow Rate to Evaluate Efficacy of Cough
    Description Peak Expiratory Flow 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.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Pre-Implant - Spontaneous Effort Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Arm/Group Description Peak expiratory flow (L/s) during spontaneous efforts. Peak expiratory flow (L/s) during spinal cord stimulation (Use of the Cough System)
    Measure Participants 12 12
    Mean (Standard Error) [L/s]
    2.1
    (0.4)
    10.7
    (1.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pre-Implant - Spontaneous Effort, Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Comments Each patient was served as their own control; comparisons was made at various points in the study (Week #3, #7, #11, #15, #20, #24, #28, #40, #52, 18-Month and 24-Month).
    Type of Statistical Test Other
    Comments Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.
    Statistical Test of Hypothesis p-Value <0.05
    Comments A p value of < 0.05 was taken as indicating statistical significance.
    Method ANOVA
    Comments Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.
    2. Primary Outcome
    Title Measurements of Maximum Airway Pressure to Evaluate Efficacy of Cough
    Description Maximum Expiratory Pressure is the highest pressure that can be developed during a forceful expiratory effort against an occluded airway.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Pre-Implant - Spontaneous Effort Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Arm/Group Description Airway pressure generation during spontaneous efforts Airway pressure generation during spinal cord stimulation (use of the Cough System)
    Measure Participants 12 12
    Mean (Standard Error) [cmH2O]
    26
    (4)
    118
    (14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pre-Implant - Spontaneous Effort, Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Comments Each patient was served as their own control; comparisons were made at various points in the study (Week #3, #7, #11, #15, #20, #24, #28, #40, #52, 18-Month and 24-Month).
    Type of Statistical Test Other
    Comments Statistical analyses were performed using a repeated measures analysis of variance and Paired t test. A p value was calculated.
    Statistical Test of Hypothesis p-Value <0.05
    Comments A p value of < 0.05 was taken as indicating statistical significance.
    Method ANOVA
    Comments Statistical analyses will be performed using a repeated measures analysis of variance and Paired t test.
    3. Secondary Outcome
    Title Assessment of Need for Caregiver Support for Secretion Management as Measured by a Caregiver Burden Inventory and Quality of Life Survey
    Description The data prior to implantation (control) were compared with data obtained after implantation (Week #3, #7, #11, #15, #20, #24, #28, #40, #52,18-Mth and 24-Mth) of the cough system. Survey will assess time dependency, personal development, and physical, social, and emotional health of the caregiver, as well as assess specific need for caregiver's assistance in managing secretions. Objectives: To determine caregiver burden and quality of life of primary family caregivers before use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did providing assistance with managing the airway secretions of the person you care for cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much)
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Pre-Implantation Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Arm/Group Description Objectives: To determine caregiver burden and quality of life of primary family caregivers before use of the cough stimulation system (Cough System) Design: Prospective assessment via questionnaire responses Question: To what extent did providing assistance with managing the airway secretions of the person you care for cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much) Objectives: To determine caregiver burden and quality of life of primary family caregivers after use of the cough stimulation system (Cough System). Design: Prospective assessment via questionnaire responses. Question: To what extent did providing assistance with managing the airway secretions of the person you care for cause you stress? On a scale of 0-3 (0 = Not at all, 1 = a little, 2 = Quite a bit and 3 = Very much)
    Measure Participants 12 12
    Mean (Standard Error) [score on a scale]
    1.67
    (0.34)
    0.33
    (0.17)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pre-Implant - Spontaneous Effort, Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Comments The data prior to implantation (control) were compared with data obtained after implantation (Week #3, #7, #11, #15, #20, #24, #28, #40, #52,18-Mth and 24-Mth) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ±SEs.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments A p value of < 0.05 was taken as indicating statistical significance.
    Method nonparametric analog (Freidman Test)
    Comments
    4. Secondary Outcome
    Title Assessment of Ease in Expectoration of Secretions Using a Secretion Management Index
    Description Survey will assess difficulty, frequency, and severity of subject's secretion management. Objectives: To determine the sputum index 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, 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty).
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Pre-Implantation Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Arm/Group Description Objectives: To determine the sputum index 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, 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty). Objectives: To determine the sputum index 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, 1 = Mild (Rarely have difficulty), 2 = Moderate (Occasional difficulty) 3 = Marked (Frequent difficulty) and 4=Severe (Usually have great difficulty).
    Measure Participants 12 12
    Mean (Standard Error) [score on a scale]
    2.78
    (0.36)
    0.33
    (0.17)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pre-Implant - Spontaneous Effort, Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Comments The data prior to implantation (control) were compared with data obtained after implantation (Week #3, #7, #11, #15, #20, #24, #28, #40, #52,18-Mth and 24-Mth) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ±SEs.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments A p value of < 0.05 was taken as indicating statistical significance.
    Method nonparametric analog (Freidman Test)
    Comments
    5. Secondary Outcome
    Title Number of Respiratory Tract Infections Over the 2-year Period
    Description 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 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.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Number of Respiratory Tract Infections Over the 2-year Period - Pre-Implant Number of Respiratory Tract Infections Over the 2-year Period - Post-Implant
    Arm/Group Description 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.
    Measure Participants 12 12
    Mean (Standard Error) [Respiratory tract infections per year]
    2.25
    (0.30)
    0.09
    (0.09)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pre-Implant - Spontaneous Effort, Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Comments The data prior to implantation (control) were compared with data obtained after implantation (Week #3, #7, #11, #15, #20, #24, #28 ,#40, #52, 18-Mth and 24-Mth) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. Paired t test. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ±SEs.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments A p value of < 0.05 was taken as indicating statistical significance.
    Method nonparametric analog (Freidman Test)
    Comments
    6. Secondary Outcome
    Title Assessment of Quality of Life
    Description 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)
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Pre-Implantation Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Arm/Group Description 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) 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)
    Measure Participants 12 12
    Mean (Standard Error) [score on a scale]
    2.3
    (0.2)
    0.3
    (0.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Pre-Implant - Spontaneous Effort, Post-Implantation - After Use of the Cough Stimulation System (Cough System)
    Comments The data prior to implantation (control) were compared with data obtained after implantation (Week #3, #7, #11, #15, #20, #24, #28, #40, #52, 18-Mth and 24-Mth) of the cough system using a nonparametric analog (Friedman Test) to the standard repeated measures analysis of variance. A p value was calculated. This alpha level was chosen as a correlation for inflated type I error rates because of multiple comparisons. Results are reported as means ±SEs.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value <0.05
    Comments A p value of < 0.05 was taken as indicating statistical significance.
    Method nonparametric analog (Freidman Test)
    Comments

    Adverse Events

    Time Frame 2 years
    Adverse Event Reporting Description
    Arm/Group Title Post-Implantation; Spinal Cord Stimulation With Wire Leads to Restore Cough
    Arm/Group Description Procedure/Surgery: Implantation of device; Device: Expiratory Muscle Stimulator The expiratory muscle stimulator (Cough System) 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. Use of the spinal cord stimulation (SCS) Cough System was associated with some side effects, most notably increases in blood pressure and decreases in heart rate, consistent with autonomic dysreflexia (AD). AD was limited to the early phase of SCS and occurred in a total of 6 subjects. Over a period of several weeks of daily SCS however, this response gradually abated and eventually resolved in each subject. Mild back and leg jerking without associated discomfort was also observed in some subjects. This effect was well controlled by reducing the intensity of SCS. There was no evidence of bowel or bladder leakage. The Cough System have had to be explanted in one participant due increase in frequency and severity of muscle spasm.
    All Cause Mortality
    Post-Implantation; Spinal Cord Stimulation With Wire Leads to Restore Cough
    Affected / at Risk (%) # Events
    Total 0/12 (0%)
    Serious Adverse Events
    Post-Implantation; Spinal Cord Stimulation With Wire Leads to Restore Cough
    Affected / at Risk (%) # Events
    Total 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Post-Implantation; Spinal Cord Stimulation With Wire Leads to Restore Cough
    Affected / at Risk (%) # Events
    Total 6/12 (50%)
    Nervous system disorders
    Hemodynamic effect - Initial increases in blood pressure and decreases in heart rate 6/12 (50%) 6
    Muscle spasm 1/12 (8.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Anthony F. DiMarco, MD
    Organization MetroHealth Medical Center
    Phone 216-778-3906
    Email afd3@case.edu
    Responsible Party:
    Anthony F. Dimarco, Professor, MetroHealth Medical Center
    ClinicalTrials.gov Identifier:
    NCT01659541
    Other Study ID Numbers:
    • IRB 15-00014
    • U01NS083696
    First Posted:
    Aug 8, 2012
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Jul 1, 2022