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Wearable Focal Vibration for Peripheral Neuropathy

N/A

Recruiting

Led By Hongwu Wang, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sufficient cognition to consent, confirmed by recall of key study points

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)

Must not have

Lower limb deficiency/amputations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 6-week intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how vibration can reduce nerve pain in cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an early-phase feasibility study focusing on focal vibration therapy, specific side effects are not detailed but may include discomfort at the site of application or temporary increase in neuropathic symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand and remember the key points of the study.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a missing limb or part of a limb below my waist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to Myovolt focal vibration

Feasibility of enrollment

Secondary study objectives

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Functional Well-Being Subscale

Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity-12 (FACT-GOG/NTX-12) Physical Well-Being Subscale

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

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Focal vibration therapyExperimental Treatment1 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.

0 / 4Eligibility criteria met