Focal NeuropathiesNCT01394822
Neuromuscular Ultrasound for Focal Neuropathies
An observational study of Focal Neuropathies and Carpal Tunnel Syndrome, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this study is to determine if a new diagnostic technique, called neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Neuropathies, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals presenting to the Diagnostic Neurology Laboratory at Wake Forest Baptist Medical Center for evaluation of focal nerve disease.
Who may be able to join
- Electrodiagnostic finding of focal nerve disease
- Age 18 and older
Who cannot join
- Skin lesions preventing ultrasound
- Known ultrasound gel allergy
- Unable to complete 6 months of follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
The purpose of this study is to determine if a new diagnostic technique, called neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease.
- Conditions
- Focal Neuropathies, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Median Neuropathy, Ulnar Neuropathy, Peroneal Neuropathy
- Medical subject headings
- Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Median Neuropathy, Ulnar Neuropathies, Peroneal Neuropathies, Radial Neuropathy, Sciatic Neuropathy, Tibial Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound results reported | Not described | |
| Ultrasound results NOT reported | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Neuropathy Sum Score
Neuropathy specific scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal NeuropathiesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Cartwright, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394822
- Sponsor's protocol ID
- NINDS-K23NS062892
- Status last verified
- Dec 2014
- First submitted
- 13 Jul 2011
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mandeville R, Wali A, Park C, Groessl E, Walker FO, Cartwright MS. Cost-effectiveness of neuromuscular ultrasound in focal neuropathies. Neurology. 2019 Jun 4;92(23):e2674-e2678. doi: 10.1212/WNL.0000000000007602. Epub 2019 May 3.
PubMed 31053668
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Ultrasound for Focal Neuropathies
- ClinicalTrials.gov ID
- NCT01394822
- Acronym / sponsor ID
- NINDS-K23NS062892
- Conditions
- Focal Neuropathies, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Median Neuropathy, Ulnar Neuropathy, Peroneal Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Jul 2011 (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 this study is to determine if a new diagnostic technique, called neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound results reported | – | – |
| Ultrasound results NOT reported | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting to the Diagnostic Neurology Laboratory at Wake Forest Baptist Medical Center for evaluation of focal nerve disease.
Key inclusion criteria (2 listed)
- Electrodiagnostic finding of focal nerve disease
- Age 18 and older
Key exclusion criteria (3 listed)
- Skin lesions preventing ultrasound
- Known ultrasound gel allergy
- Unable to complete 6 months of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Neuropathy Sum Score
Time frame: 6 months
Neuropathy specific scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 31053668Mandeville R, Wali A, Park C, Groessl E, Walker FO, Cartwright MS. Cost-effectiveness of neuromuscular ultrasound in focal neuropathies. Neurology. 2019 Jun 4;92(23):e2674-e2678. doi: 10.1212/WNL.0000000000007602. Epub 2019 May 3.
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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.
Michael S Cartwright principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Neuropathies and Carpal Tunnel Syndrome, run by Wake Forest University at 1 site 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?
The sponsor lists 2 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Neuropathy Sum Score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01394822, which also lists 1 linked publication.
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 Nov 2017.