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

October 27, 2006
June 5, 2007
August 2006
Not Provided
Validity of the NeuroPath
Same as current
Complete list of historical versions of study NCT00393549 on ClinicalTrials.gov Archive Site
Accuracy of the NeuroPath
Same as current
Not Provided
Not Provided
 
NeuroPath Comparative Validation Study Plan
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Carpal Tunnel Syndrome (CTS)
Device: NeuroPath
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
December 2006
Not Provided

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00393549
VALP-000986
Not Provided
Not Provided
Excel-Tech Ltd.
Not Provided
Study Director: Ron Kurtz Excel-Tech Ltd. (XLTEK)
Excel-Tech Ltd.
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP