Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116337
Status:
COMPLETED
Last Update Posted:
2020-05-04
First Post:
2005-06-28
Brief Title:
Spinal Cord Stimulation to Restore Cough
Sponsor:
MetroHealth Medical Center
Organization:
MetroHealth Medical Center
Study Overview
Official Title:
Spinal Cord Stimulation to Restore Cough
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 278855 | OTHER_GRANT | Neilsen Foundation | None |
| IRB 98-00091 | None | None | None |