Trial Outcomes & Findings for Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy (NCT NCT04959929)
NCT ID: NCT04959929
Last Updated: 2026-07-20
Results Overview
Percent of interested individuals who enrolled.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Baseline
Results posted on
2026-07-20
Participant Flow
Participant milestones
| Measure |
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.
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).
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|---|---|
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Overall Study
STARTED
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13
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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.
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).
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Focal Vibration Therapy
n=13 Participants
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.
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).
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
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10 Participants
n=20 Participants
|
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Age, Categorical
>=65 years
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3 Participants
n=20 Participants
|
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Age, Continuous
|
55.5 years
STANDARD_DEVIATION 9.6 • n=20 Participants
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Sex: Female, Male
Female
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10 Participants
n=20 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
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1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
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9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
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Region of Enrollment
United States
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13 participants
n=20 Participants
|
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CIPN Persistence (yrs)
|
4.2 years
STANDARD_DEVIATION 3.4 • n=20 Participants
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Cancer Type
gynecological
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3 Participants
n=20 Participants
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Cancer Type
breast
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5 Participants
n=20 Participants
|
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Cancer Type
testicular
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1 Participants
n=20 Participants
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Cancer Type
hematological
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2 Participants
n=20 Participants
|
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Cancer Type
colorectal
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2 Participants
n=20 Participants
|
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Diabetes
diabetes
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4 Participants
n=20 Participants
|
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Diabetes
no diabetes
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9 Participants
n=20 Participants
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BMI
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29.2 kg/sq m
STANDARD_DEVIATION 5.7 • n=20 Participants
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PRIMARY outcome
Timeframe: BaselinePopulation: Overall Number of Participants Analyzed represents number of participants screened for study eligibility prior to enrollment.
Percent of interested individuals who enrolled.
Outcome measures
| Measure |
Focal Vibration Therapy
n=18 Participants
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.
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).
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|---|---|
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Feasibility of Enrollment
|
72 percentage of screened participants
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PRIMARY outcome
Timeframe: After 6-week interventionPopulation: Excluded 1 participant who did not return diary but reported full adherence in weekly check-ins.
Number of completed sessions the intervention was worn, as a percentage of the number of sessions prescribed.
Outcome measures
| Measure |
Focal Vibration Therapy
n=10 Participants
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.
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).
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|---|---|
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Adherence to Myovolt Focal Vibration
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96.4 percentage of sessions prescribed
Standard Deviation 5.8
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SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionPopulation: 0 (no change) was input for the 2 participants who did not complete the study.
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.
Outcome measures
| Measure |
Focal Vibration Therapy
n=13 Participants
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.
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).
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|---|---|
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Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory
|
-5 points
Interval -19.0 to 5.5
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SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionPopulation: 0 (no change) was input for the 2 participants who did not complete the study.
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.
Outcome measures
| Measure |
Focal Vibration Therapy
n=13 Participants
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.
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).
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|---|---|
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Neuropathy Total Symptom Score-6 (NTSS-6)
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-0.83 scores on a scale
Interval -6.5 to 1.7
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SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionPopulation: 0 (no change) was input for the 2 participants who did not complete the study.
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). Sensory and motor severity are rated separately.
Outcome measures
| Measure |
Focal Vibration Therapy
n=13 Participants
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.
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).
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|---|---|
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Patient Neurotoxicity Questionnaire (PNQ)
No Change in Sensory or Motor Ratings
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6 Participants
|
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Patient Neurotoxicity Questionnaire (PNQ)
Sensory Rating Improved 1 Level
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2 Participants
|
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Patient Neurotoxicity Questionnaire (PNQ)
Motor Rating Improved 1 Level
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2 Participants
|
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Patient Neurotoxicity Questionnaire (PNQ)
Motor Rating Improved 2 Levels
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1 Participants
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Patient Neurotoxicity Questionnaire (PNQ)
Sensory and Motor Rating Each Improved 1 Level
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2 Participants
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SECONDARY outcome
Timeframe: After 6-week interventionPopulation: 0 (no change) was input for the 2 participants who did not complete the study.
The GROC scale is a universal clinical outcome providing a simple but comprehensive "umbrella" patient-perspective of change. Scores on a 9-point ordinal scale centered around 0 (Unchanged) ranged from -4 (very much worse) to 0 (unchanged) to +4 (very much better).
Outcome measures
| Measure |
Focal Vibration Therapy
n=13 Participants
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.
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).
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|---|---|
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Global Rating of Change (GROC) Scale
Worse (Any Level: A Little, Somewhat, Quite a Bit, Very Much)
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0 Participants
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Global Rating of Change (GROC) Scale
Unchanged
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5 Participants
|
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Global Rating of Change (GROC) Scale
A Little Better
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4 Participants
|
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Global Rating of Change (GROC) Scale
Somewhat Better
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0 Participants
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Global Rating of Change (GROC) Scale
Quite A Bit Better
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3 Participants
|
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Global Rating of Change (GROC) Scale
Very Much Better
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1 Participants
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SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionPopulation: 0 (no change) was input for the 2 participants who did not complete the study.
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.
Outcome measures
| Measure |
Focal Vibration Therapy
n=13 Participants
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.
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).
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|---|---|
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Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale
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0.5 scores on a scale
Interval -4.0 to 12.5
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SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionPopulation: 0 (no change) was input for the 2 participants who did not complete the study.
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.
Outcome measures
| Measure |
Focal Vibration Therapy
n=13 Participants
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.
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).
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|---|---|
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Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale
|
0 scores on a scale
Interval -5.5 to 6.5
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SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionMMT assesses muscle strength by an assessor applying pressure against the hallux as the participant lifts and holds 1st metatarsophalangeal extension. Strength is rated from 0 (weakest) to 5 (strongest). Change of 1 grade from the baseline values is categorized as improvement or decline.
Outcome measures
| Measure |
Focal Vibration Therapy
n=11 Participants
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.
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).
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|---|---|
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Manual Muscle Testing (MMT) of Toes
At Least 1 Medical Research Council Grade Below Baseline Value
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0 Participants
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Manual Muscle Testing (MMT) of Toes
No Change (MMT within 1 Medical Research Council Grade) From Baseline Value
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10 Participants
|
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Manual Muscle Testing (MMT) of Toes
At Least 1 Medical Research Council Grade Above Baseline Value
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0 Participants
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Manual Muscle Testing (MMT) of Toes
Missing MMT (Completed Remote Visit - Questionnaires Only)
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1 Participants
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SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionPopulation: 1 participant completed a remote 6-week visit (questionnaires only).
QuHalEx(TM) measures toe strength by reading force measurements (higher is stronger) when participants sit with foot strapped on a portable base of a proprietary University of Oklahoma QuHalEx(TM) load-cell prototype device (U.S. Patent 11402284 issued to the University of Oklahoma on 08/02/2022, and provisional patent 63/627,850). With the great toe inserted into a cap, the participant pulls up and holds isometrically for a few seconds. The peak force is the highest value recorded over the hold time. We report the change in peak force from baseline to the 6-week visit.
Outcome measures
| Measure |
Focal Vibration Therapy
n=10 Participants
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.
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).
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|---|---|
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Change in Toe Strength Using a Proprietary Quantifiable Toe Measurement Device, Quantification of Hallux Extension Strength or QuHalEx(TM), U.S. Patent 11402284 Issued to the University of Oklahoma on 08/02/2022, and Provisional Patent 63/627,850.
|
-0.5 kg
Interval -1.2 to 0.5
|
SECONDARY outcome
Timeframe: Change from Baseline after 6-week InterventionPopulation: 1 participant completed a remote 6-week visit (questionnaires only).
Vibratory threshold is measured by a non-invasive vibrating probe (biothesiometer) placed on the skin and increased from 0 Hz until the amplitude when the participant first reports detection (eyes closed) or the maximum amplitude available on the biothesiometer scale (50 Volts). Higher indicates worse sensation.
Outcome measures
| Measure |
Focal Vibration Therapy
n=10 Participants
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.
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).
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|---|---|
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Vibration Perception Threshold Using Biothesiometer
|
0.5 Volts
Interval -13.0 to 18.0
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Adverse Events
Focal Vibration Therapy
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Focal Vibration Therapy
n=13 participants at risk
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.
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).
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|---|---|
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Skin and subcutaneous tissue disorders
Pruritis
|
7.7%
1/13 • Number of events 1 • 6 weeks
Weekly survey during the intervention period, Daily diaries
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.4%
2/13 • Number of events 2 • 6 weeks
Weekly survey during the intervention period, Daily diaries
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
15.4%
2/13 • Number of events 2 • 6 weeks
Weekly survey during the intervention period, Daily diaries
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
15.4%
2/13 • Number of events 2 • 6 weeks
Weekly survey during the intervention period, Daily diaries
|
|
Nervous system disorders
Paresthesia
|
23.1%
3/13 • Number of events 3 • 6 weeks
Weekly survey during the intervention period, Daily diaries
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • 6 weeks
Weekly survey during the intervention period, Daily diaries
|
Additional Information
Elizabeth Hile, PhD, PT
University of Oklahoma Health Campus
Phone: (405) 271-2273
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place