Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-25 @ 7:06 PM
Study NCT ID:
NCT02722434
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2016-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MC5-A Scrambler Therapy or TENS Therapy in Treating Patients With Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Mayo Clinic
Organization:
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 and/or 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 and/or 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2016-00368 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MC15C1 | OTHER | Mayo Clinic | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |