Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy

NCT04959929 | Active Not Recruiting FDA Device

• 1 other identifier: 12621
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

focal vibration; wearable; in-home rehabilitation; chemotherapy-induced peripheral neuropathy; CIPN; lower extremity

Outcome Measures

Primary Outcomes (2)

• Feasibility of enrollment

  Percent of interested individuals who enrolled.

  Baseline

• Adherence to Myovolt focal vibration

  Number of completed days and sessions of Number of days (or sessions) the intervention was worn, as a percentage of the number of days (or sessions) the device was prescribed.

  After 6-week intervention

Secondary Outcomes (10)

• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory

  Change from Baseline after 6-week Intervention

• Neuropathy Total Symptom Score-6 (NTSS-6)

  Change from Baseline after 6-week Intervention

• Patient Neurotoxicity Questionnaire (PNQ)

  Change from Baseline after 6-week Intervention

• Global Rating of Change (GROC) scale

  After 6-week withdrawal period

• Long-term retention

  After 6-week withdrawal period

Study Arms (1)

Focal vibration therapy

EXPERIMENTAL

Myovolt delivers vibration with a frequency between 50-80 Hz. Myovolt intensity will be set to \~up to 2X the participant's initial Myovolt perception threshold. If the stimulation does not feel strong, the participant will be asked to manually increase the intensity until it feels strong but comfortable.

Device: Focal vibration therapy

Interventions

Focal vibration therapy DEVICE

Myovolt is a wearable rehabilitative device that delivers vibration to the region of the body where the motors are worn. Participants are asked to apply the vibration to specific leg locations twice a day, for about 30 minutes at a time, and to record their response using a provided log. They may be asked to try applying the device at different location or using different vibration parameters (pulse frequency or intensity).

Also known as: Myovolt

Focal vibration therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Cancer patients with current symptoms of chemotherapy induced peripheral neuropathy affecting the feet, persisting for at least 3 months after completion of chemotherapy, and not substantially improving in recent weeks. The CIPN must be painful, or severe enough to interfere with function, activities, or participation (generally NCI-CTCAE Grade II)
• Clinically stable to participate in study assessments and the intervention (at a minimum, able to stand independently from a chair and walk household distances without help from another person)
• Able to read and speak English, give a voluntary written consent
• Sufficient cognition to consent, confirmed by recall of key study points
• Use of pain medications (opioids, anti-convulsants, and antidepressants) must be stable in the two weeks prior to study enrollment, and the participant must agree to avoid significant changes in pain medication regimen during the period of active study participation, and to notify the study team if medications change

You may not qualify if:

• Neuropathy (known or suspected) of any etiology other than chemotherapy or diabetes (for example, due to alcohol, vitamin deficiency, autoimmune disorder, CMT, idiopathic
• Unsafe/unable to self-apply the focal vibration intervention for any reason (for example, insufficient hand dexterity or cognitive executive function
• Recent or fluctuating musculoskeletal injury or lesion that would impact physical performance
• Lower limb deficiency/amputations
• Pregnant, or planning to get pregnant in the next 6 months. Pre-menopausal females who enroll agree to notify the study team as soon as possible should they become pregnant

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Stephenson Cancer Center, OU Health

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (4)

• Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.

  PMID: 28586243 BACKGROUND

• Monfort SM, Pan X, Patrick R, Ramaswamy B, Wesolowski R, Naughton MJ, Loprinzi CL, Chaudhari AMW, Lustberg MB. Gait, balance, and patient-reported outcomes during taxane-based chemotherapy in early-stage breast cancer patients. Breast Cancer Res Treat. 2017 Jul;164(1):69-77. doi: 10.1007/s10549-017-4230-8. Epub 2017 Apr 3.

  PMID: 28374323 BACKGROUND

• Miaskowski C, Mastick J, Paul SM, Abrams G, Cheung S, Sabes JH, Kober KM, Schumacher M, Conley YP, Topp K, Smoot B, Mausisa G, Mazor M, Wallhagen M, Levine JD. Impact of chemotherapy-induced neurotoxicities on adult cancer survivors' symptom burden and quality of life. J Cancer Surviv. 2018 Apr;12(2):234-245. doi: 10.1007/s11764-017-0662-8. Epub 2017 Nov 20.

  PMID: 29159795 BACKGROUND

• Murillo N, Valls-Sole J, Vidal J, Opisso E, Medina J, Kumru H. Focal vibration in neurorehabilitation. Eur J Phys Rehabil Med. 2014 Apr;50(2):231-42.

  PMID: 24842220 BACKGROUND

Study Officials

• Elizabeth Hile, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: July 13, 2021
• Study Start: February 9, 2023
• Primary Completion: July 22, 2024
• Study Completion: July 1, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion and publication of primary outcomes
• Access Criteria: Only de-identified data will be shared with permission from the funder and PI per request

Locations

US (1)