Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

Status Recruiting

Clinical Trial Summary

This study will perform an early Phase I feasibility study with single-arm, double-baseline repeated measured design. The investigators will test the feasibility of using focal vibration to improve symptoms of persistent CIPN.

Clinical Trial Description

This is an initial Phase I single-site, single-arm, double-baseline repeated measures feasibility study of wearable focal vibration (FV with Myovolt) for persistent chemotherapy-induced peripheral neuropathy. We will enroll up to 15 cancer survivors who are cancer-free and meet all other inclusion/ exclusion criteria, including CIPN symptoms at least 3 months after final chemotherapy infusion. Participants will undergo baseline assessments (V1) of questionnaires and performance tests, and may repeat these tests within a few days as a double-baseline (V2). In addition, they complete 7-days of baseline symptom monitoring by diary before starting 6 weeks of daily at-home therapy with a Myovolt wearable FV device. A study coach will check in by phone or video calls during the intervention period. Participants undergo post-testing immediately after the 6-week intervention (V3), and after another 6 weeks without FV (V4). In total, participants attend 3-4 onsite study visits, a 6-week intervention period with weekly remote check-in contact from the study team, and a 6-week intervention-free follow-up period with at least one remote check-in. Participants will keep a provided daily symptom diary during the primary study period (i.e., 6 weeks), and at least weekly in the 6-week follow-up period. ;

Study Design

Related Conditions & MeSH terms

Chemotherapy-induced Peripheral Neuropathy
Peripheral Nervous System Diseases

Clinical Trial Details

NCT number	NCT04959929
Study type	Interventional
Source	University of Oklahoma
Contact	Josiah Rippetoe, BS
Phone	4052711529
Email	josiah-rippetoe@ouhsc.edu
Status	Recruiting
Phase	N/A
Start date	February 9, 2023
Completion date	December 31, 2024

View Details

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