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Sub-study to Spinal Cord Stimulation to Restore Cough

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ClinicalTrials.gov Identifier: NCT00995215
Recruitment Status : Completed
First Posted : October 15, 2009
Results First Posted : April 14, 2020
Last Update Posted : April 14, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Anthony F. Dimarco, MetroHealth Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Spinal Cord Injuries
Spinal Cord Diseases
Paralysis
Central Nervous System Diseases
Cough
Interventions Procedure: Spinal Cord Stimulation
Device: Expiratory Muscle Stimulator
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Spinal Cord Stimulation
Hide Arm/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

Spinal Cord Stimulation: 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.

Expiratory Muscle Stimulator: T

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Evaluation of Temporary, Intra-operative Wire Lead Placement i
Hide Arm/Group Description These studies were performed in subjects (n=6) undergoing surgery for permanent placement of disc electrodes to restore cough in our previous clinical trial
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
These studies were performed in subjects (n=6) undergoing surgery for permanent placement of disc electrodes to restore cough in our previous clinical trial.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
42.6
(20 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Patient with cervical spinal cord injury   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
6
 100.0%
[1]
Measure Description: The purpose of this study is to evaluate the efficacy of a wire electrode design temporarily placed during the surgical procedures for study 98-00091. The wire electrodes and the disc electrodes [currently in use] are each tested intra-operatively, and the results compared
1.Primary Outcome
Title The Effects of Electrical Spinal Cord Stimulation (SCS) on Airway Pressure Generation While Using Temporarily Placed Parallel Wire Leads and Implanted Disc Electrodes
Hide Description The effects of SCS with temporarily placed parallel wire leads and then with permanently implanted disc electrodes on airway pressure generation in each participant was evaluated in the operating room. The wire electrodes were temporarily placed (immediately prior to placement of disc electrodes as part of the current clinical trial) over the surface of the spinal cord on the lower back. These electrodes were activated, and the degree of expiratory muscle activation were assessed. The wire electrodes were then removed. Small, disc electrodes were then permanently implanted to stimulate expiratory muscles and restore cough. All measurements were repeated. Since SCS with the disc electrode leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.
Time Frame intra-operative
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with spinal cord injury with expiratory muscle paralysis.
Arm/Group Title Spinal Cord Stimulation (SCS) With Disc Electrodes Spinal Cord Stimulation (SCS) With Parallel Wire Leads
Hide Arm/Group Description:
Effects of electrical spinal cord stimulation with disc on airway pressure generation was evaluated.
Effects of electrical spinal cord stimulation (SCS) with parallel wire leads on airway pressure generation was evaluated.
Overall Number of Participants Analyzed 6 6
Mean (Standard Error)
Unit of Measure: cmH2O
56  (13) 54  (9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Spinal Cord Stimulation (SCS) With Disc Electrodes, Spinal Cord Stimulation (SCS) With Parallel Wire Leads
Comments The effects of electrical (spinal cord stimulation) SCS with disc electrode and wire leads on airway pressure generation were compared. Since SCS with the disc leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.
Type of Statistical Test Other
Comments Statistical analysis was performed using a repeated measures analysis of variance and paired t-test.
Statistical Test of Hypothesis P-Value 0.05
Comments A P value <0.05 was taken as indicative of statistical significance.
Method ANOVA
Comments [Not Specified]
Time Frame intra-operative
Adverse Event Reporting Description No Adverse Events reported
 
Arm/Group Title Spinal Cord Stimulation
Hide Arm/Group Description

Experimental: Spinal Cord Stimulation

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.

All-Cause Mortality
Spinal Cord Stimulation
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Serious Adverse Events
Spinal Cord Stimulation
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Spinal Cord Stimulation
Affected / at Risk (%)
Total   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anthony Dimarco
Organization: MetroHealth Medical Center
Phone: 216-778-3906
EMail: adimarco@metrohealth.org
Layout table for additonal information
Responsible Party: Anthony F. Dimarco, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00995215    
Other Study ID Numbers: IRB08-00269/IRB98-00091
IRB08-00269 ( Other Identifier: IRB )
IRB98-00091 ( Other Identifier: IRB )
First Submitted: October 14, 2009
First Posted: October 15, 2009
Results First Submitted: July 31, 2019
Results First Posted: April 14, 2020
Last Update Posted: April 14, 2020