NCT02357355

Brief Summary

Charcot Marie Tooth 1A (CMT 1A) is a common inherited disorder of the nerves in the body. The disease can result in difficulties with strength and balance as well as in foot deformities such as high arches, hammer toes, and tight ankles. Because of these difficulties, the disease may affect driving, especially because driving requires quick responses at times such as slamming on the brakes or turning the steering wheel quickly. The following study determines driving performance in individuals who have CMT 1A.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

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

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

January 13, 2015

Last Update Submit

March 7, 2017

Conditions

CMT 1A

Outcome Measures

Primary Outcomes (1)

  • Driving Error Rate

    1 year

Secondary Outcomes (3)

  • Deceleration speed

    1 year

  • Time to braking

    1 year

  • Time to apply steering maneuvers

    1 year

Study Arms (2)

CMT 1A Group

ACTIVE COMPARATOR

Patients with CMT 1A will undergo a driving simulation study. The intervention will be the SIREN driving simulator.

Device: UIHC Driving Simulator

Control Group

ACTIVE COMPARATOR

Patients without CMT 1A who are our normal controls will undergo a driving simulation study. The intervention will be the SIREN driving simulator.

Device: UIHC Driving Simulator

Interventions

UIHC Driving SimulatorDEVICE

This is a driving simulator located in the basement of the hospital. A car will be facing a large video screen of a driving simulation.

Also known as: SIREN Driving Simulator
CMT 1A GroupControl Group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have CMT 1A
  • Have a valid driver's license

You may not qualify if:

  • History of other types of neuropathy (other than CMT 1A)
  • History of blindness, seizures, or stroke, dementia/cognitive dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor NeuropathyNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Nivedita U. Jerath, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 13, 2015

First Posted

February 6, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

US(1)