Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
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|ClinicalTrials.gov Identifier: NCT04959929|
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : February 22, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Peripheral Neuropathy||Device: Focal vibration therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.|
|Masking:||None (Open Label)|
|Official Title:||Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy|
|Actual Study Start Date :||February 9, 2023|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||September 30, 2023|
Experimental: Focal vibration therapy
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
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).
Other Name: Myovolt
- Feasibility of enrollment [ Time Frame: Baseline ]Percent of interested individuals who enrolled.
- Adherence to Myovolt focal vibration [ Time Frame: After 6-week intervention ]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.
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory [ Time Frame: Change from Baseline after 6-week Intervention ]The FACT-GOG/Ntx-12 is a composite measure of CIPN symptoms and functional impairments and related quality of life, scored from 0 to 48 where a higher score indicates worse neuropathy symptoms.
- Neuropathy Total Symptom Score-6 (NTSS-6) [ Time Frame: Change from Baseline after 6-week Intervention ]The NTSS-6 rates neuropathic symptoms (severity and frequency) in 6-categories. Scores range from 0 to 21.96, and higher scores indicate higher symptom burden.
- Patient Neurotoxicity Questionnaire (PNQ) [ Time Frame: Change from Baseline after 6-week Intervention ]The PNQ grades the extent of sensory and motor neuropathy in cancer cohorts scored from grade A (no neuropathy, also Grade 0) to grade E (severe neuropathy, also Grade 4) for both sensory and motor symptoms.
- Global Rating of Change (GROC) scale [ Time Frame: After 6-week withdrawal period ]The GROC scale is a universal clinical outcome providing a simple but comprehensive "umbrella" patient-perspective of change with scores ranging from -5 (very much worse) to 0 (unchanged) to +5 (completely recovered).
- Long-term retention [ Time Frame: After 6-week withdrawal period ]Number of enrolled individuals retained for long-term follow-up(after 6-week withdrawal period), and reasons for loss to follow-up, when available.
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale [ Time Frame: Change from Baseline after 6-week Intervention ]The FACT-GOG/Ntx-12 PWB subscale is a patient-report measure of physical symptoms and function. Scored from 0 to 28, higher scores indicate better well-being.
- Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale [ Time Frame: Change from Baseline after 6-week Intervention ]The FACT-GOG/Ntx-12 FWB subscale is a patient-report measure of functional well-being with questions about work, leisure and sleep, and a summary quality of life(QoL)rating. Scores range from 0 to 28, higher scores indicate better well-being and QoL.
- Manual Muscle Testing (MMT) of Toes [ Time Frame: Change from Baseline after 6-week Intervention ]MMT assesses muscle strength by an assessor applying pressure against the toes as the participant lifts or curls their toes and is rated from 0 (weakest) to 5 (strongest).
- Toe Strength using a quantifiable toe measurement device [ Time Frame: Change from Baseline after 6-week Intervention ]The toe strength quantifiable toe measurement device measures toe strength by reading force measurements when participants sit with foot strapped on a portable base of a load-cell prototype device of PI Dr. Hile and her team, with toe inserted into housing against which they pull up for a few seconds, or press down.
- Vibration Perception Threshold using Biothesiometer [ Time Frame: Change from Baseline after 6-week Intervention ]Vibratory threshold will be measured by a non-invasive vibrating probe (biothesiometer) placed on the skin. Vibration intensity is measured in frequency where the frequency is increased until the participant reports feeling it (eyes closed) from 0 to 50 Hz.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04959929
|Contact: Elizabeth Hile, PhDemail@example.com|
|Contact: Kathleen Moore, MDfirstname.lastname@example.org|
|United States, Oklahoma|
|Stephenson Cancer Center, OU Health||Recruiting|
|Oklahoma City, Oklahoma, United States, 73104|
|Contact: Elizabeth Hile, PhD 405-271-1529 email@example.com|
|Sub-Investigator: Kathleen Moore, PhD|
|Principal Investigator:||Elizabeth Hile, PhD||University of Oklahoma|
|Responsible Party:||University of Oklahoma|
|Other Study ID Numbers:||
|First Posted:||July 13, 2021 Key Record Dates|
|Last Update Posted:||February 22, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The de-identified data might be shared with permission from the funder and PI per request.|
Statistical Analysis Plan (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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
chemotherapy-induced peripheral neuropathy
Peripheral Nervous System Diseases
Nervous System Diseases