Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy

NCT05041816 | Withdrawn FDA Device

• 1 other identifier: 13593
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.

Conditions

Diabetic Peripheral Neuropathy

Keywords

focal vibration; wearable; nerve conduction study; pain; mobility

Outcome Measures

Primary Outcomes (8)

• Changes in CMAP

  The peroneal compound muscle action potential (CMAP)

  Change from Baseline CMAP measures every 2 weeks for up to 6 weeks

• Changes in NCV

  The peroneal motor nerve conduction velocity

  Change from Baseline NCV measures every 2 weeks for up to 6 weeks

• Changes in SNAP

  The digital sensory nerve action potentials

  Change from Baseline SNAP measures every 2 weeks for up to 6 weeks

• Changes in BPI-DPN

  The Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy

  Change from Baseline BPI-DPN scores every 2 weeks for up to 6 weeks

• Changes in TUG

  Timed Up and Go (TUG) test

  Change from Baseline TUG scores every 2 weeks for up to 6 weeks

• Changes in NTSS-6

  The Neuropathy Total Symptom Score - 6-items (NTSS-6), which quantifies frequency and intensity of aching, burning, prickling and lancinating pain, numbness, and allodynia in patients' feet and legs.

  Change from Baseline NTSS-6 scores every 2 weeks for up to 6 weeks

• Changes in NSS

  The Neuropathy Symptom Score (NSS), which quantifies symptoms of motor, sensory, and autonomic deficits.

  Change from Baseline NSS scores every 2 weeks for up to 6 weeks

• Changes in NIS

  The Neurologic Impairment Score (NIS), composed of a sensory sub-score (which evaluates sensory perceptions to touch, prickling pain, vibration, joint position, and 1- and 10-g monofilaments in the upper and lower extremities) and a motor sub-score (which evaluates cranial nerves, muscle strength, muscle wasting, and deep tendon reflexes in the upper and lower extremities).

  Change from Baseline NIS scores every 2 weeks for up to 6 weeks

Study Arms (1)

Focal vibration group

EXPERIMENTAL

The Myovolt device used in our previous study will be used for focal vibration delivery during week three to six. Participants will wear Myovolt secured by an elastic band, at a location based on therapist and participants preference. During the four weeks of the FV therapy, participants will be asked to use the Myovolt device for up to 0.5-hour per session (each site 10 minutes per session, with one-minute intersession between sites), once in the morning and once in the evening each day, for five days a week. The dosing paradigm was chosen based on the safety and potential effectiveness of the FV therapy, and our preliminary study.

Device: Focal vibration therapy

Interventions

Focal vibration therapy DEVICE

Myovolt delivers vibration with a frequency between 60-300 Hz, and acceleration force between 1.8g to 19.1g peak to peak. Myovolt intensity will be set to \~up to 2X the participant's initial Myovolt perception threshold (however, the maximum intensity will be limited to 19.1g which is the maximum intensity the device can deliver). 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 group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetes for at least one year;
• Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested;
• Age 45-80 years old;
• Able to ambulate independently without assistive devices (e.g., walker or crutches) for 30 feet;
• No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions;
• Able to understand English instructions;
• Have normal or corrected vision.

You may not qualify if:

• With other non-diabetic causes of neuropathy by history;
• Symptomatic peripheral vascular disease, joint pain, swelling and/or limited range of motion in the lower extremities that interfere with walking;
• Other systemic or local diseases that could interfere with walking assessment
• Amputation in the lower extremities;
• Clinically diagnosed with dementia greater than mild (screened using Montreal Cognitive Assessment (MOCA) \<24)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

• Rippetoe J, Wang H, James SA, Dionne C, Block B, Beckner M. Improvement of Gait after 4 Weeks of Wearable Focal Muscle Vibration Therapy for Individuals with Diabetic Peripheral Neuropathy. J Clin Med. 2020 Nov 22;9(11):3767. doi: 10.3390/jcm9113767.

  PMID: 33266464 BACKGROUND

• Chandrashekhar R, Wang H, Dionne C, James S, Burzycki J. Wearable Focal Muscle Vibration on Pain, Balance, Mobility, and Sensation in Individuals with Diabetic Peripheral Neuropathy: A Pilot Study. Int J Environ Res Public Health. 2021 Mar 2;18(5):2415. doi: 10.3390/ijerph18052415.

  PMID: 33801216 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongwu Wang, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 6-week, single group, repeated measures with double baselines research design to characterize the changes in sensory and motor nerve performance in DPN, and examine the relations between these changes and changes in pain and mobility

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: September 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the 6 weeks study
• Access Criteria: Only de-identified data will be shared with permission from the funder and PI per request

Locations

US (1)