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Trial record 2 of 329 for:    CMT

Driving Ability in Patients With CMT 1A

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: NCT02357355
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jerath U Nivedita, University of Iowa

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.

Condition or disease Intervention/treatment Phase
CMT 1A Device: UIHC Driving Simulator Not Applicable

Detailed Description:
Individuals with CMT 1A will drive in a driving simulator, which involves a car located in a room in the University of Iowa Hospitals and Clinics (UIHC). Individuals will drive in the car as if they are driving in real life and the whole experience is like playing a car video game with a big animated screen. The driving results will be compared to similar aged patients who don't have CMT 1A and have also taken the driving test. If patients with CMT 1A do have driving difficulties compared to those who do not have CMT 1A, the results of the study will try to help patients with CMT1A drive better by ultimately creating devices that might help them use the steering wheel or brake pedal in a safer way.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Driving Ability in Patients With CMT 1A
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 1, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CMT 1A Group
Patients with CMT 1A will undergo a driving simulation study. The intervention will be the SIREN driving simulator.
Device: UIHC Driving Simulator
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.
Other Name: SIREN Driving Simulator

Active Comparator: Control Group
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
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.
Other Name: SIREN Driving Simulator




Primary Outcome Measures :
  1. Driving Error Rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Deceleration speed [ Time Frame: 1 year ]
  2. Time to braking [ Time Frame: 1 year ]
  3. Time to apply steering maneuvers [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357355


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52246
Sponsors and Collaborators
Jerath U Nivedita
Investigators
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Principal Investigator: Nivedita U. Jerath, MD University of Iowa

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Responsible Party: Jerath U Nivedita, PI, University of Iowa
ClinicalTrials.gov Identifier: NCT02357355     History of Changes
Other Study ID Numbers: 201307807
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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4-des-dimethylaminotetracycline
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action