NeuroPath Comparative Validation Study Plan

This study has been terminated.
(Sponsor decision to terminate.)
Sponsor:
Information provided by:
Excel-Tech Ltd.
ClinicalTrials.gov Identifier:
NCT00393549
First received: October 27, 2006
Last updated: June 5, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Carpal Tunnel Syndrome (CTS)
Device: NeuroPath
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Excel-Tech Ltd.:

Primary Outcome Measures:
  • Validity of the NeuroPath

Secondary Outcome Measures:
  • Accuracy of the NeuroPath

Estimated Enrollment: 200
Study Start Date: August 2006
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393549

Locations
United States, Alabama
Harmonex Neuroscience Research
Dothan,, Alabama, United States, 36303
United States, Florida
SunCoast Neuroscience Associateion
St. Petersburg, Florida, United States, 33701
Sponsors and Collaborators
Excel-Tech Ltd.
Investigators
Study Director: Ron Kurtz Excel-Tech Ltd. (XLTEK)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00393549     History of Changes
Other Study ID Numbers: VALP-000986
Study First Received: October 27, 2006
Last Updated: June 5, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Excel-Tech Ltd.:
Median Neuropathy at the wrist (MNW)

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on July 28, 2014