Diabetic Peripheral NeuropathyNCT05041816
Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy
A study testing Focal vibration therapy in people with Diabetic Peripheral Neuropathy, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetic 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the detailed description
Peripheral nerve impairments are highly prevalent in patients with diabetic peripheral neuropathy (DPN) and are associated with pain and poor mobility. While peripheral sensorimotor nerve function is implicated in neuropathy, the mechanism associated with both pain and mobility is not well understood. Even less understood is the interplay between, and responses to, sensory and motor fibers of the affected peripheral nerve. In our previous study, focal vibration (FV) was effective in reducing pain and improving mobility for only a subgroup of participants with DPN. Because FV stimulates both motor and sensory peripheral nerve fibers, when combined with nerve conduction testing, it offers a unique opportunity to study both the sensory and motor peripheral nerve performance and their contribution to pain and mobility in patients with DPN. We are proposing a single group, repeated measured study to: characterize the changes in sensory and motor peripheral nerve functions; examine the association(s) between these changes and changes in pain and mobility, using FV. If successful, this study will provide us with a better understanding of the role played by sensory and motor nerve impairments in pain and mobility for DPN, and support larger clinical studies to optimize nerve function performance and the FV parameters. We will also explore how changes in the peripheral nerve function associate with severity of DPN.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Focal vibration therapy
- Keywords
- focal vibration, wearable, nerve conduction study, pain, mobility
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal vibration therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Focal vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in CMAP
The peroneal compound muscle action potential (CMAP)
Measured: Change from Baseline CMAP measures every 2 weeks for up to 6 weeks
Changes in NCV
The peroneal motor nerve conduction velocity
Measured: Change from Baseline NCV measures every 2 weeks for up to 6 weeks
Changes in SNAP
The digital sensory nerve action potentials
Measured: 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
Measured: Change from Baseline BPI-DPN scores every 2 weeks for up to 6 weeks
Changes in TUG
Timed Up and Go (TUG) test
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from Baseline NIS scores every 2 weeks for up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Sep 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Why it stopped: The PI resigned and the recruitment had not been started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic 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
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwu Wang, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041816
- Sponsor's protocol ID
- 13593
- Status last verified
- Mar 2024
- First submitted
- 3 Sep 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- 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
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.
PubMed 33266464Chandrashekhar 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.
PubMed 33801216
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05041816
- Acronym / sponsor ID
- 13593
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- focal vibration, wearable, nerve conduction study, pain, mobility
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI resigned and the recruitment had not been started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peripheral nerve impairments are highly prevalent in patients with diabetic peripheral neuropathy (DPN) and are associated with pain and poor mobility. While peripheral sensorimotor nerve function is implicated in neuropathy, the mechanism associated with both pain and mobility is not well understood. Even less understood is the interplay between, and responses to, sensory and motor fibers of the affected peripheral nerve. In our previous study, focal vibration (FV) was effective in reducing pain and improving mobility for only a subgroup of participants with DPN. Because FV stimulates both motor and sensory peripheral nerve fibers, when combined with nerve conduction testing, it offers a unique opportunity to study both the sensory and motor peripheral nerve performance and their contribution to pain and mobility in patients with DPN. We are proposing a single group, repeated measured study to: characterize the changes in sensory and motor peripheral nerve functions; examine the association(s) between these changes and changes in pain and mobility, using FV. If successful, this study will provide us with a better understanding of the role played by sensory and motor nerve impairments in pain and mobility for DPN, and support larger clinical studies to optimize nerve function performance and the FV parameters. We will also explore how changes in the peripheral nerve function associate with severity of DPN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Focal vibration group | Experimental | Device: Focal vibration therapyThe 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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)
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 therapyMyovolt 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. | Device | Focal vibration group |
Primary outcome
Changes in CMAP
Time frame: Change from Baseline CMAP measures every 2 weeks for up to 6 weeks
The peroneal compound muscle action potential (CMAP)
Changes in NCV
Time frame: Change from Baseline NCV measures every 2 weeks for up to 6 weeks
The peroneal motor nerve conduction velocity
Changes in SNAP
Time frame: Change from Baseline SNAP measures every 2 weeks for up to 6 weeks
The digital sensory nerve action potentials
Changes in BPI-DPN
Time frame: Change from Baseline BPI-DPN scores every 2 weeks for up to 6 weeks
The Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy
Changes in TUG
Time frame: Change from Baseline TUG scores every 2 weeks for up to 6 weeks
Timed Up and Go (TUG) test
Changes in NTSS-6
Time frame: Change from Baseline NTSS-6 scores every 2 weeks for up to 6 weeks
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.
Changes in NSS
Time frame: Change from Baseline NSS scores every 2 weeks for up to 6 weeks
The Neuropathy Symptom Score (NSS), which quantifies symptoms of motor, sensory, and autonomic deficits.
Changes in NIS
Time frame: Change from Baseline NIS scores every 2 weeks for up to 6 weeks
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 33266464Rippetoe 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.
- Background: PubMed 33801216Chandrashekhar 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.
- 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.
Hongwu Wang, 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 Diabetic 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 7 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: withdrawn, as of the sponsor's last update on 6 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Changes in CMAP (time frame: Change from Baseline CMAP measures every 2 weeks for up to 6 weeks). The study lists 8 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 NCT05041816, which also lists 2 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 6 Mar 2024.