NeuroPath Comparative Validation Study Plan

June 5, 2007 updated by: Excel-Tech Ltd.
The purpose of the study is to compare the performance of the NeuroPath automated nerve conduction test with the standard of care manual test in the diagnosis of entrapment neuropathies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Dothan,, Alabama, United States, 36303
        • Harmonex Neuroscience Research
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • SunCoast Neuroscience Associateion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Symptomatic Inclusion Criteria:

  • sensory symptoms (numbness and/or tingling) in at least 2 of digits 1,2,3 and 4, in at least one hand, for at least 1 month, prior to the start of the clinical study. The sensory symptoms may be intermittent or constant, but if constant, there must have been a period of time during which the symptoms were intermittent. The numbness and tingling may be accompanied by pain, but pain alone is not sufficient to meet this first inclusion criteria.
  • Sensory symptoms (numbness and/or tingling) aggravated by at least 1 of the following: sleep, sustained hand or arm positioning, or repetitive actions of the hand.
  • Sensory symptoms (numbness and/or tingling) mitigated by at least 1 of the following: changes in hand posture, shaking the hand, or use of a wrist splint.
  • If pain is present, the wrist, hand, and finger pain is greater than elbow, shoulder, or neck pain if there is pain in any or all of those locations.

Symptomatic Exclusion Criteria:

  • Sensory symptoms exclusive or predominatly in the little finger (D5) (ulnar neuropathy).
  • Neck pain or shoulder pain preceded the paresthesia in the digits (cervical radiculopathy and/or brachial plexopathy).
  • Numbness and/or tingling in the feet that preceded or accompanied the sensory symptoms in the hands (polyneuropathy).
  • Medical history and physical examination that indicates an explanation for the sensory symptoms which is more probable than CTS. For example, digital neuropathy, median nerve pathology proximal to the carpal tunnel, ulnar neuropathy, radical neuropathy, brachial plexopathy, cervical radiculopathy, spinal cord, brainstem or brain pathology, or a polyneuropathy.
  • Absence of 1st, 3rd, 4th or 5th digits
  • Open wounds at the measurement sites
  • Excessive sensitivity to electrical stimulation
  • Median nerve injection in the past 30 days
  • Prior carpal tunnel surgery
  • Patients who are susceptible to radio frequency noise - such as patients with pacemakers or patients that have electrical stimulators of any sort.

Control Subject Inclusion Criteria:

  • Normal neurological examination

Control Subject Exclusion Criteria:

  • Absence of 1st, 3rd or 5th digits
  • Open wounds at the measurement sites
  • Excessive sensitivity to electrical stimulation
  • Median nerve injection in the past 30 days
  • Prior carpal tunnel surgery
  • Reported history of CTS, polyneuropathy, diabetes,renal failure, thyroid disease or Vitamin B 12 deficiency
  • Patients who are susceptible to radio frequency noise-such as patients with pacemakers or patients that have electrical stimulators of any sort.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Validity of the NeuroPath

Secondary Outcome Measures

Outcome Measure
Accuracy of the NeuroPath

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Excel-Tech Ltd.

Investigators

  • Study Director: Ron Kurtz, Excel-Tech Ltd. (XLTEK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 27, 2006

First Submitted That Met QC Criteria

October 27, 2006

First Posted (Estimate)

October 29, 2006

Study Record Updates

Last Update Posted (Estimate)

June 6, 2007

Last Update Submitted That Met QC Criteria

June 5, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALP-000986

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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