Wearable Focal Vibration for Peripheral Neuropathy

Recruiting at 1 trial location

Overseen By Abby Cha, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Non-chemotherapy neuropathy, Musculoskeletal injury, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You don't have to stop taking your current medications, but your pain medication must be stable for two weeks before joining the study, and you should avoid making big changes to it during the study.

What data supports the effectiveness of the treatment Focal Vibration Therapy for Peripheral Neuropathy?

A study on wearable focal muscle vibration therapy showed significant improvements in pain, mobility, and sensation for people with diabetic peripheral neuropathy after four weeks of treatment. Participants reported less pain and better walking ability, and they were highly satisfied with the therapy. ^{1 2 3 4 5}

Is wearable focal vibration therapy safe for humans?

Wearable focal vibration therapy has been studied in people with diabetic peripheral neuropathy and showed improvements in pain, mobility, and sensation without any reported safety concerns. Participants in these studies were satisfied with the therapy and fully complied with the treatment, suggesting it is generally safe for human use. ^{1 3 4 6 7}

How is Focal Vibration Therapy different from other treatments for peripheral neuropathy?

Focal Vibration Therapy is unique because it uses a wearable device to deliver targeted vibrations to specific muscles, which can improve pain, balance, mobility, and sensation in people with diabetic peripheral neuropathy. Unlike standard treatments, which are limited, this therapy is non-invasive and can be done at home, offering a novel approach to managing symptoms. ^{1 3 4 5 6}

Research Team

Elizabeth Hile, PhD

Principal Investigator

University of Oklahoma

Eligibility Criteria

This trial is for adults over 18 with painful or function-affecting nerve damage in the feet due to chemotherapy, stable for at least 3 months. Participants must have a consistent pain medication regimen and be able to stand and walk short distances unaided. They should not have neuropathy from other causes, lower limb loss, recent injuries affecting movement, or be pregnant.

Inclusion Criteria

I understand and remember the key points of the study.

My pain medication has been the same for the last two weeks and I agree not to change it during the study.

I have had painful or severe nerve pain in my feet from chemotherapy for over 3 months.

Exclusion Criteria

I have a recent injury affecting my physical ability.

I have neuropathy not caused by chemotherapy or diabetes.

I am not pregnant nor planning to be in the next 6 months, but will inform the study team if I become pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments of questionnaires and performance tests, and may repeat these tests within a few days as a double-baseline

1 week

1-2 visits (in-person)

Treatment

Participants complete 6 weeks of daily at-home therapy with a Myovolt wearable FV device, with weekly remote check-ins

6 weeks

Weekly remote check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment, with at least one remote check-in

6 weeks

At least 1 remote check-in

Treatment Details

Interventions

• Focal Vibration Therapy

Trial Overview The study is testing focal vibration therapy as a treatment for persistent symptoms of chemotherapy-induced peripheral neuropathy (CIPN). It's an early Phase I trial with a single group of participants who will receive the therapy to see if it helps improve their CIPN symptoms.

Participant Groups

Group I: Focal vibration therapy Experimental Treatment 1 Intervention

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 is already approved in European Union, United States for the following indications:

Approved in European Union as Focal Vibration Therapy for:

• Musculoskeletal conditions
• Neurological rehabilitation
• Spasticity management

Approved in United States as Focal Vibration Therapy for:

• Chronic pain management
• Rehabilitation after stroke
• Peripheral neuropathy

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Findings from Research

Local calf vibration therapy significantly improved balance in patients with diabetic peripheral neuropathy (DPN), as indicated by an increase in the Brief BESTest scores from 14.06 to 17.35 after treatment.

The therapy also led to a notable increase in common peroneal nerve conduction velocity in the treated leg compared to the control leg, suggesting potential benefits for nerve function in DPN patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of local calf vibration on balance, blood flow, and nerve conductivity in patients with diabetic peripheral neuropathy: a pilot study. Fateh, HR., Nakhostin Ansari, N., Nakhostin-Ansari, A., et al.[2023]

In a study involving 32 participants (17 with diabetic neuropathy and 15 nondisabled), vibrating insoles improved standing balance in individuals with neuropathy, but only when they were distracted by an attention-demanding task.

No balance improvement was observed in nondisabled subjects, suggesting that the vibrating insoles may specifically benefit those with balance issues related to neuropathy, highlighting the need for further development to enhance their effectiveness in daily use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibrating insoles on standing balance in diabetic neuropathy. Hijmans, JM., Geertzen, JH., Zijlstra, W., et al.[2022]

Whole body vibration (WBV) therapy significantly improves pain, neuropathy disability, balance, and quality of life in patients with painful diabetic peripheral neuropathy (PDPN) after six weeks of treatment, as shown in a study of 26 participants.

The study found that WBV therapy led to notable improvements in various measures, including pain ratings and vibration perception, compared to a control group receiving standard care, highlighting its potential as an effective adjunct therapy for PDPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. Jamal, A., Ahmad, I., Ahamed, N., et al.[2022]

A 4-week study involving 23 participants with diabetic peripheral neuropathy showed that wearable focal muscle vibration (FMV) therapy significantly reduced pain levels and improved mobility, with participants reporting high satisfaction and compliance.

While balance and sensation improvements were noted, they were not statistically significant; however, there was a trend suggesting that better balance may correlate with reduced pain levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. Chandrashekhar, R., Wang, H., Dionne, C., et al.[2021]

An 8-week program of low-frequency plantar vibration training significantly improved nerve conduction velocity in the feet of 12 patients with diabetic peripheral neuropathy (DPN).

Participants also experienced enhanced postural stability and a reduction in pain and tingling sensations, indicating the training's potential benefits for managing DPN symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive effects of plantar vibration training for the treatment of diabetic peripheral neuropathy: A pilot study. Stambolieva, K., Petrova, D., Irikeva, M.[2018]

Focal muscle vibration at 80 Hz and amplitudes of 0.3 mm and 0.5 mm effectively inhibits the H-reflex in healthy subjects, suggesting potential benefits for reducing spasticity in patients with lower limb issues.

The study indicates that using focal vibration as an adjuvant therapy during gait rehabilitation could be beneficial for patients with calf muscle spasticity, warranting further clinical trials to explore its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Focal Muscle Vibration on Calf Muscle Spasticity: A Proof-of-Concept Study. Seo, HG., Oh, BM., Leigh, JH., et al.[2022]

Focal vibratory treatment (FVT) applied to muscles can lead to significant improvements in muscle force and power in healthy adults, with effects lasting for several months after treatment.

The most effective FVT involves applying vibrations at a frequency of approximately 100 Hz to voluntarily contracted muscles, repeated multiple times over three to five days, showing comparable benefits to traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the Focal Muscle Vibration an Effective Motor Conditioning Intervention? A Systematic Review. Fattorini, L., Rodio, A., Pettorossi, VE., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of local calf vibration on balance, blood flow, and nerve conductivity in patients with diabetic peripheral neuropathy: a pilot study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of vibrating insoles on standing balance in diabetic neuropathy. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Positive effects of plantar vibration training for the treatment of diabetic peripheral neuropathy: A pilot study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Focal Muscle Vibration on Calf Muscle Spasticity: A Proof-of-Concept Study. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Is the Focal Muscle Vibration an Effective Motor Conditioning Intervention? A Systematic Review. [2023]