Chemotherapy-induced Peripheral NeuropathyNCT04959929
Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
A study testing Focal vibration therapy in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Focal vibration therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center, OU Health
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the detailed 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.
- Being tested
- Focal vibration therapy
- Keywords
- focal vibration, wearable, in-home rehabilitation, chemotherapy-induced peripheral neuropathy, CIPN, lower extremity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal vibration therapyDevice
Also called Myovolt
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Focal vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment
Percent of interested individuals who enrolled.
Measured: Baseline
Adherence to Myovolt Focal Vibration
Number of completed sessions the intervention was worn, as a percentage of the number of sessions prescribed.
Measured: After 6-week intervention
Secondary outcomes (9)
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Symptom Inventory
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.
Measured: Change from Baseline after 6-week Intervention
Neuropathy Total Symptom Score-6 (NTSS-6)
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.
Measured: Change from Baseline after 6-week Intervention
Patient Neurotoxicity Questionnaire (PNQ)
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.
Measured: Change from Baseline after 6-week Intervention
Global Rating of Change (GROC) Scale
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).
Measured: After 6-week intervention
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale
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.
Measured: Change from Baseline after 6-week Intervention
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale
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.
Measured: Change from Baseline after 6-week Intervention
Manual Muscle Testing (MMT) of Toes
MMT 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.
Measured: Change from Baseline after 6-week Intervention
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.
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.
Measured: Change from Baseline after 6-week Intervention
Vibration Perception Threshold Using Biothesiometer
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.
Measured: Change from Baseline after 6-week Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start9 Feb 2023
- Primary completion22 Jul 2024
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Hile, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959929
- Sponsor's protocol ID
- 12621P
- Status last verified
- Jun 2026
- First submitted
- 29 Mar 2021
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified data might be shared with permission from the funder and PI per request.
Publications
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.
PubMed 28586243Monfort 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.
PubMed 28374323Miaskowski 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.
PubMed 29159795Murillo 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.
PubMed 24842220
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Focal Vibration for Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04959929
- Acronym / sponsor ID
- 12621P
- Keywords
- focal vibration, wearable, in-home rehabilitation, chemotherapy-induced peripheral neuropathy, CIPN, lower extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be assigned to a single group that will receive focal vibration therapy using Myovolt.
| Arm | Type | Receives |
|---|---|---|
| Focal vibration therapy | Experimental | Device: Focal vibration therapyMyovolt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal vibration therapyAlso: MyovoltMyovolt 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). | Device | Focal vibration therapy |
Primary outcome
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 sessions the intervention was worn, as a percentage of the number of sessions prescribed.
9 secondary outcomes
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
Neuropathy Total Symptom Score-6 (NTSS-6)
Time frame: Change from Baseline after 6-week Intervention
Patient Neurotoxicity Questionnaire (PNQ)
Time frame: Change from Baseline after 6-week Intervention
Global Rating of Change (GROC) Scale
Time frame: After 6-week intervention
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
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
Manual Muscle Testing (MMT) of Toes
Time frame: Change from Baseline after 6-week Intervention
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.
Time frame: Change from Baseline after 6-week Intervention
Vibration Perception Threshold Using Biothesiometer
Time frame: Change from Baseline after 6-week Intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28586243Winters-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.
- Background: PubMed 28374323Monfort 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.
- Background: PubMed 29159795Miaskowski 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.
- Background: PubMed 24842220Murillo 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.
- Individual participant dataSharing planned: Yes. The de-identified data might be shared with permission from the funder and PI per request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Hile, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal vibration therapy in people with Chemotherapy-induced Peripheral Neuropathy, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Enrollment (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04959929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.