Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05411523
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-06-06
Brief Title:
Assessing Effect of Spinal Cord Stimulation on Pain and Quality of Life with Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Prospective Observational Study Assessing Efficacy of 10-kHz Spinal Cord Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This study examines how spinal cord stimulation SCS affects pain level and quality of life in patients experiencing chemotherapy-induced peripheral neuropathy CIPN CIPN is a nerve problem and one of the potential side effects of chemotherapy that causes pain numbness tingling swelling or muscle weakness in different parts of the body CIPN usually begins in the hands or feet and gets worse over time SCS is a type of therapy that has proven to be effective in treating numerous non-malignant pain disorders including failed back surgery syndrome refractory angina limb ischemia complex regional pain syndrome and diabetic peripheral neuropathy SCS may also be useful in patients with CIPN This study evaluates how SCS affects pain and quality of life in patients undergoing spinal cord stimulation for CIPN
Detailed Description:
PRIMARY OBJECTIVES
I To measure percentage of responders who had at least 50 reduction in lower extremity pain at 6 months
II To measure overall improvement in neurological assessment at 6 months III To measure secondary metrics including change in perceived global changesatisfaction health-related quality of life and sleep disturbance
IV To determine if there are any significant adverse events encountered with spinal cord stimulation SCS therapy for cancer-related pain
OUTLINE
Patients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3 6 and 12 months
I To measure percentage of responders who had at least 50 reduction in lower extremity pain at 6 months
II To measure overall improvement in neurological assessment at 6 months III To measure secondary metrics including change in perceived global changesatisfaction health-related quality of life and sleep disturbance
IV To determine if there are any significant adverse events encountered with spinal cord stimulation SCS therapy for cancer-related pain
OUTLINE
Patients receiving spinal cord stimulation therapy complete questionnaires over 30 minutes at baseline and at 3 6 and 12 months
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-2022-02976 | REGISTRY | CTRP Clinical Trial Reporting Program | None |