Study Results
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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TERMINATED
PHASE3
200 participants
INTERVENTIONAL
2006-08-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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NeuroPath
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Excel-Tech Ltd.
INDUSTRY
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
SunCoast Neuroscience Associateion
St. Petersburg, Florida, United States
Countries
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Other Identifiers
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VALP-000986
Identifier Type: -
Identifier Source: org_study_id