NeuroPath Comparative Validation Study Plan

NCT00393549 | Terminated Phase 3

• 1 other identifier: VALP-000986
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Median Neuropathy at the wrist (MNW)

Outcome Measures

Primary Outcomes (1)

• Validity of the NeuroPath

Secondary Outcomes (1)

• Accuracy of the NeuroPath

Interventions

NeuroPath DEVICE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Normal neurological examination
• 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

Sponsors & Collaborators

• Excel-Tech Ltd.: lead

Study Sites (2)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

SunCoast Neuroscience Associateion

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Ron Kurtz

  Excel-Tech Ltd. (XLTEK)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 27, 2006
• First Posted: October 30, 2006
• Study Start: August 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 6, 2007

Record last verified: 2007-06

Locations

US (2)