NCT01394822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 6, 2017

Status Verified

December 1, 2014

Enrollment Period

2.5 years

First QC Date

July 13, 2011

Last Update Submit

November 2, 2017

Conditions

Focal NeuropathiesCarpal Tunnel SyndromeCubital Tunnel SyndromeMedian NeuropathyUlnar NeuropathyPeroneal NeuropathyRadial NeuropathySciatic NeuropathyTibial Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Overall Neuropathy Sum Score

    Neuropathy specific scale

    6 months

Study Arms (2)

Ultrasound results reported

Ultrasound results NOT reported

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals presenting to the Diagnostic Neurology Laboratory at Wake Forest Baptist Medical Center for evaluation of focal nerve disease.

You may qualify if:

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

You may not qualify if:

  • Skin lesions preventing ultrasound
  • Known ultrasound gel allergy
  • Unable to complete 6 months of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • 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.

    PMID: 31053668DERIVED

MeSH Terms

Conditions

Carpal Tunnel SyndromeCubital Tunnel SyndromeMedian NeuropathyUlnar NeuropathiesPeroneal NeuropathiesRadial NeuropathySciatic NeuropathyTibial Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesUlnar Nerve Compression Syndromes

Study Officials

  • Michael S Cartwright

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 14, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 6, 2017

Record last verified: 2014-12

Locations

US(1)