Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
Study NCT ID:
NCT06019793
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-09
First Post:
2023-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrophysiological Recordings from Deep Brain Stimulation Electrodes for Pain
Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Organization:
Study Overview
Official Title:
Electrophysiological Recordings from Deep Brain Stimulation Electrodes for Pain
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-11
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:
EPR Pain
Brief Summary:
Over the last 30 years, deep brain stimulation (DBS) has allowed tens of thousands of patients to receive relief of neurological symptoms that were refractory to standard medical treatment. Furthermore, by providing a rare window into the electrophysiological activity of the awake, human brain, DBS has facilitated invaluable advances in scientific understanding. These advances have then, in turn, allowed for further therapies to be developed for an ever growing population of patients that benefit from DBS therapy. This study hopes to add to this growing body of knowledge by implanting leads within, and recording from, the sensory thalamus and periaqueductal gray (PAG) in patients with chronic pain. Specifically, we hope to establish the long-term safety of DBS leads within the periaqueductal gray and sensory thalamus for the treatment of chronic pain. Furthermore, by recording from the electrodes of DBS patients implanted for treatment of their chronic pain, we hope to understand how the pain network responds to sensory stimuli and how DBS changes this response.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: