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Neubie Direct Current Electrical Stimulation Device for Neuropathy

N/A

Waitlist Available

Research Sponsored by NeuFit - Neurological Fitness and Education

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial will compare two types of electrical stimulation to see which is more effective in treating neuropathy. Outcomes will be measured by pain, ability to feel vibration, and score on a neuropathy scale.

Eligible Conditions

Neuropathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Distal Latency

Fibular Motor Nerve Conduction Velocity

H-Reflex

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transcutaneous Electrical Nerve StimulationExperimental Treatment1 Intervention

The control group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min footbath with TENS and 15-min of various physical therapy exercises.

Group II: Neubie Direct Current Electrical StimulationExperimental Treatment1 Intervention

The experimental group subjects follow with 12 sessions of physical therapy over a 6-week period which include: a 30-min foot bath session using the Neubie and 15-min of various physical therapy exercises.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS

2011

Completed Phase 2

~2040

Neubie Direct Current Electrical Stimulation Device

2022

N/A

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NeuFit - Neurological Fitness and EducationLead Sponsor

2 Previous Clinical Trials

6 Total Patients Enrolled

Ramona von Leden, PhDStudy DirectorNeuFit - Neurological Fitness and Education

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for individuals to join this medical experiment?

"Affirmative. Clinicaltrials.gov data shows that this clinical trial is recruiting participants, having been posted August 1st of 2022 and last updated October 10th of the same year. 150 patients are needed across 10 separate medical sites."

Answered by AI

Are there many medical facilities in North America engaged with this clinical trial?

"Currently, this trial is recruiting from 10 different sites located across the US. These range from Fort Myers to Clearwater and Astoria with several more in between; it's advisable to select a location close by to reduce the amount of travelling required if you decide to join."

Answered by AI

What is the capacity of this clinical trial in regards to participants?

"This research study necessitates 150 suitable participants. Those who meet the requirements may join from various physical therapy facilities such as APEX Physical Therapy in Fort Myers, FL and Catalyst Physical Therapy in Clearwater, OK."

Answered by AI

Who else is applying?

What state do they live in?

Oklahoma

California

Virginia

How old are they?

18 - 65

What site did they apply to?

Courcier Physical Therapy

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I ve seen a PCP, Podiatrist, Physiatrist, Neurologist and an Orthopaedic surgeon, All with the same results. Here are some meds for pain. I would rather see a more holistic approach.

PatientReceived 2+ prior treatments

I was diagnosed with peripheral neuropathy about 30 years ago. Now it is getting bad, mainly affecting my lower legs and feet and my foot-balance for about three years. I am 80 years old. I suffered an Ischemic stroke in 2026. My stroke affected mainly my speech center of activity and extremely short-term memory, 4-8 seconds. I am functionally not able to speak. I have severe apraxia and lesser extent aphasia. (Apraxia is motor planning to make the right sound.) (The short-term memory loss is particularly problematic for writing. It took me about half an hour to write “Why did you apply to this trial?” with the help of writing aid software.) I lost a minor amount of strength on my left side, say about 20%. I used to be athletic. I won the national championships two times in wildwater canoeing, taking the gold. I am a motivated person.

PatientReceived 2+ prior treatments

Recent research and studies

International Wound JournalJournal

Update from the Diabetic Foot Global Conference (dfcon) 2007

Rogers, Lee C, George Andros, and David G Armstrong. 2007. “Update from the Diabetic Foot Global Conference (dfcon) 2007”. International Wound Journal. Wiley. doi:10.1111/j.1742-481x.2007.00377.x.

The Journal of PainJournal

Transcutaneous Electrical Nerve Stimulation: Basic Science Mechanisms and Clinical Effectiveness

Sluka, Kathleen A., and Deirdre Walsh. 2003. “Transcutaneous Electrical Nerve Stimulation: Basic Science Mechanisms and Clinical Effectiveness”. The Journal of Pain. Elsevier BV. doi:10.1054/jpai.2003.434.

DiabetologiaJournal

Effective Treatment of Symptomatic Diabetic Polyneuropathy by High-frequency External Muscle Stimulation

Reichstein, L., S. Labrenz, D. Ziegler, and S. Martin. 2005. “Effective Treatment of Symptomatic Diabetic Polyneuropathy by High-frequency External Muscle Stimulation”. Diabetologia. Springer Science and Business Media LLC. doi:10.1007/s00125-005-1728-0.

Neural Regeneration ResearchJournal