Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389721
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-25
Brief Title:
Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Cohort 1 To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy CIPN
Cohort 2 To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy CIPN and to test a certain type of experimental neuromodulation stimulation of the brain with a device called a closed-loop brain-computer interface clBCI to see if can help to prevent pain due to CIPN
Cohort 2 To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy CIPN and to test a certain type of experimental neuromodulation stimulation of the brain with a device called a closed-loop brain-computer interface clBCI to see if can help to prevent pain due to CIPN
Detailed Description:
Primary Objectives
Objective 1 Primary Objective to examine preliminary baseline and serial electrophysiological markers associated with the onset and development of CIPN by tracking brain activity and CIPN symptoms throughout chemotherapy treatment
Secondary Objectives
Objective 2 Secondary Objective To preliminarily evaluate whether a clBCI program can regulate changes in EEG that are associated with CIPN while participants are undergoing chemotherapy
Exploratory Objective Explore whether there are associations between change in brain function and subjective report of CIPN
Objective 1 Primary Objective to examine preliminary baseline and serial electrophysiological markers associated with the onset and development of CIPN by tracking brain activity and CIPN symptoms throughout chemotherapy treatment
Secondary Objectives
Objective 2 Secondary Objective To preliminarily evaluate whether a clBCI program can regulate changes in EEG that are associated with CIPN while participants are undergoing chemotherapy
Exploratory Objective Explore whether there are associations between change in brain function and subjective report of CIPN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2024-03672 | OTHER | NCI-CTRP Clinical Registry | None |