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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 6-week intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My pain medication has been the same for the last two weeks and I agree not to change it during 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.
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I can stand up and walk around my house without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 6-week withdrawal period
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 6-week withdrawal period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to Myovolt focal vibration
Feasibility of enrollment
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
98,286 Total Patients Enrolled
Hongwu Wang, PhDPrincipal InvestigatorUniversity of Oklahoma
2 Previous Clinical Trials
4 Total Patients Enrolled
Elizabeth Hile, PhDPrincipal InvestigatorUniversity of Oklahoma

Media Library

Focal Vibration Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04959929 — N/A
Peripheral Neuropathy Research Study Groups: Focal vibration therapy
Peripheral Neuropathy Clinical Trial 2023: Focal Vibration Therapy Highlights & Side Effects. Trial Name: NCT04959929 — N/A
Focal Vibration Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04959929 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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~5 spots leftby Sep 2024