NeuroPath Comparative Validation Study Plan
Primary Purpose
Carpal Tunnel Syndrome (CTS)
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NeuroPath
Sponsored by
About this trial
This is an interventional diagnostic trial for Carpal Tunnel Syndrome (CTS) focused on measuring Median Neuropathy at the wrist (MNW)
Eligibility 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.
Sites / Locations
- Harmonex Neuroscience Research
- SunCoast Neuroscience Associateion
Outcomes
Primary Outcome Measures
Validity of the NeuroPath
Secondary Outcome Measures
Accuracy of the NeuroPath
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00393549
Brief Title
NeuroPath Comparative Validation Study Plan
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to terminate.
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Excel-Tech Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome (CTS)
Keywords
Median Neuropathy at the wrist (MNW)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
NeuroPath
Primary Outcome Measure Information:
Title
Validity of the NeuroPath
Secondary Outcome Measure Information:
Title
Accuracy of the NeuroPath
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Kurtz
Organizational Affiliation
Excel-Tech Ltd. (XLTEK)
Official's Role
Study Director
Facility Information:
Facility Name
Harmonex Neuroscience Research
City
Dothan,
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
SunCoast Neuroscience Associateion
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
12. IPD Sharing Statement
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NeuroPath Comparative Validation Study Plan
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