Carpal Tunnel Syndrome (CTS)Phase 3NCT00393549
NeuroPath Comparative Validation Study Plan
A Phase 3 study testing NeuroPath in people with Carpal Tunnel Syndrome (CTS), run by Excel-Tech Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- NeuroPath
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harmonex Neuroscience Research
Dothan, Alabama, 36303
SunCoast Neuroscience Associateion
St. Petersburg, Florida, 33701
About this study
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)
- Being tested
- NeuroPath
- Keywords
- Median Neuropathy at the wrist (MNW)
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroPathDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the NeuroPath
Secondary outcomes (1)
Accuracy of the NeuroPath
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startAug 2006
- Study completionDec 2006
Why it stopped: Sponsor decision to terminate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Excel-Tech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ron Kurtz, Study director, Excel-Tech Ltd. (XLTEK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393549
- Sponsor's protocol ID
- VALP-000986
- Status last verified
- Jun 2007
- First submitted
- 27 Oct 2006
- Last updated
- 6 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroPath Comparative Validation Study Plan
- ClinicalTrials.gov ID
- NCT00393549
- Acronym / sponsor ID
- VALP-000986
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Median Neuropathy at the wrist (MNW)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Excel-Tech Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroPath | Device | – |
Primary outcome
Validity of the NeuroPath
1 secondary outcome
Accuracy of the NeuroPath
Results and safety
The study was stopped early (reason given: Sponsor decision to terminate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Kurtz study director
Excel-Tech Ltd. (XLTEK)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NeuroPath in people with Carpal Tunnel Syndrome (CTS), run by Excel-Tech Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision to terminate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the NeuroPath. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2007; AzTrials last refreshed its copy on 27 Oct 2026.