NeuroPath Comparative Validation Study Plan

NCT ID: NCT00393549

Last Updated: 2007-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome (CTS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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NeuroPath

Intervention Type DEVICE

Eligibility Criteria

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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.


* Normal neurological examination

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.


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Excel-Tech Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ron Kurtz

Role: STUDY_DIRECTOR

Excel-Tech Ltd. (XLTEK)

Locations

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Harmonex Neuroscience Research

Dothan, Alabama, United States

Site Status

SunCoast Neuroscience Associateion

St. Petersburg, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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VALP-000986

Identifier Type: -

Identifier Source: org_study_id