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Neuromuscular Ultrasound for Focal Neuropathies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01394822
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date July 13, 2011
First Posted Date July 14, 2011
Last Update Posted Date November 6, 2017
Study Start Date September 2011
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2014)
Overall Neuropathy Sum Score [ Time Frame: 6 months ]
Neuropathy specific scale
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01394822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Neuromuscular Ultrasound for Focal Neuropathies
Official Title Neuromuscular Ultrasound for Focal Neuropathies
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals presenting to the Diagnostic Neurology Laboratory at Wake Forest Baptist Medical Center for evaluation of focal nerve disease.
Condition
  • Focal Neuropathies
  • Carpal Tunnel Syndrome
  • Cubital Tunnel Syndrome
  • Median Neuropathy
  • Ulnar Neuropathy
  • Peroneal Neuropathy
  • Radial Neuropathy
  • Sciatic Neuropathy
  • Tibial Neuropathy
Intervention Not Provided
Study Groups/Cohorts
  • Ultrasound results reported
  • Ultrasound results NOT reported
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 8, 2014)
120
Original Estimated Enrollment
 (submitted: July 13, 2011)
150
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Electrodiagnostic finding of focal nerve disease
  • Age 18 and older

Exclusion Criteria:

  • Skin lesions preventing ultrasound
  • Known ultrasound gel allergy
  • Unable to complete 6 months of follow-up
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01394822
Other Study ID Numbers NINDS-K23NS062892
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor Wake Forest University
Collaborators Not Provided
Investigators
Principal Investigator: Michael S Cartwright Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date December 2014