Ignite Creation Date:
2024-05-06 @ 8:22 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02722434
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2016-03-23
Brief Title:
MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
MC15C1 Randomized Scrambler Therapy vs TENS for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2021-06
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 randomized clinical trial studies how well MC5-A scrambler therapy or transcutaneous electrical nerve stimulation TENS therapy work in treating patients with chemotherapy-induced peripheral neuropathy a nerve problem that causes pain numbness tingling swelling or muscle weakness in different parts of the body MC5-A scrambler therapy is a type of treatment for nerve pain that uses electrodes placed on the skin where electricity is carried from the electrodes through the skin and blocks the pain TENS is a procedure in which mild electric currents are applied to some areas of the skin It is not yet known whether TENS therapy is more effective than MC5-A scrambler therapy in treating chemotherapy-induced peripheral neuropathy
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the efficacy of scrambler therapy MC5-A scrambler therapy compared to TENS therapy for pain andor tingling related to chemotherapy-induced peripheral neuropathy CIPN
II Evaluate the tolerability of scrambler therapy and compare it to TENS therapy in this population
III Evaluate whether scrambler therapy compared to TENS therapy can decrease the use of pain medication for CIPN
IV Explore whether messenger ribonucleic acid mRNA gene expression before and after scrambler therapy shows similar findings to what Starkweather et al observed
V Utilizing high-field magnetic resonance imaging MRI to define alterations in functional differences using resting state blood-oxygen-level dependent BOLD measures to measure differences in functional connectivity in treated with the scrambler device in the setting of chemotherapy induced peripheral neuropathy pain
VI Explore whether scrambler therapy will alter sensation
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays
ARM II Patients undergo TENS therapy over 30 minutes daily for 14 days
Patients in both Arms may crossover to the opposite Arm for an additional 2 weeks of treatment if they elect
After completion of study treatment patients are followed up weekly for 8 weeks
I Evaluate the efficacy of scrambler therapy MC5-A scrambler therapy compared to TENS therapy for pain andor tingling related to chemotherapy-induced peripheral neuropathy CIPN
II Evaluate the tolerability of scrambler therapy and compare it to TENS therapy in this population
III Evaluate whether scrambler therapy compared to TENS therapy can decrease the use of pain medication for CIPN
IV Explore whether messenger ribonucleic acid mRNA gene expression before and after scrambler therapy shows similar findings to what Starkweather et al observed
V Utilizing high-field magnetic resonance imaging MRI to define alterations in functional differences using resting state blood-oxygen-level dependent BOLD measures to measure differences in functional connectivity in treated with the scrambler device in the setting of chemotherapy induced peripheral neuropathy pain
VI Explore whether scrambler therapy will alter sensation
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients undergo MC5-A scrambler therapy over 30 minutes for 10 consecutive weekdays
ARM II Patients undergo TENS therapy over 30 minutes daily for 14 days
Patients in both Arms may crossover to the opposite Arm for an additional 2 weeks of treatment if they elect
After completion of study treatment patients are followed up weekly for 8 weeks
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 |
|---|---|---|---|
| NCI-2016-00368 | REGISTRY | None | None |
| MC15C1 | OTHER | None | None |
| P30CA015083 | NIH | Mayo Clinic | httpsreporternihgovquickSearchP30CA015083 |