Trial Outcomes & Findings for Sub-study to Spinal Cord Stimulation to Restore Cough (NCT NCT00995215)

NCT ID: NCT00995215

Last Updated: 2020-04-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: intra-operative
• Results posted on: 2020-04-14

Participant Flow

Participant milestones

Measure	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 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
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sub-study to Spinal Cord Stimulation to Restore Cough

Baseline characteristics by cohort

Measure	Evaluation of Temporary, Intra-operative Wire Lead Placement i n=6 Participants 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 <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.6 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Patient with cervical spinal cord injury	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: intra-operative

Population: Patients with spinal cord injury with expiratory muscle paralysis.

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.

Outcome measures

Measure	Spinal Cord Stimulation (SCS) With Disc Electrodes n=6 Participants Effects of electrical spinal cord stimulation with disc on airway pressure generation was evaluated.	Spinal Cord Stimulation (SCS) With Parallel Wire Leads n=6 Participants Effects of electrical spinal cord stimulation (SCS) with parallel wire leads on airway pressure generation was evaluated.
The Effects of Electrical Spinal Cord Stimulation (SCS) on Airway Pressure Generation While Using Temporarily Placed Parallel Wire Leads and Implanted Disc Electrodes	56 cmH2O Standard Error 13	54 cmH2O Standard Error 9

Adverse Events

Spinal Cord Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anthony Dimarco

MetroHealth Medical Center

Phone: 216-778-3906

Email: adimarco@metrohealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place