CMT 1ANCT02357355
Driving Ability in Patients With CMT 1A
A study testing UIHC Driving Simulator in people with CMT 1A, run by Jerath U Nivedita at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- CMT 1A
- What is being tested?
- UIHC Driving Simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 1 Jul 2016
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have CMT 1A
- Have a valid driver's license
Who cannot join
- History of other types of neuropathy (other than CMT 1A)
- History of blindness, seizures, or stroke, dementia/cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- CMT 1A
- Being tested
- UIHC Driving Simulator
- Medical subject headings
- Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UIHC Driving SimulatorDevice
Also called SIREN 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.
| Study group | Role | What they receive |
|---|---|---|
| CMT 1A Group | Active comparator | Patients with CMT 1A will undergo a driving simulation study. The intervention will be the SIREN driving simulator. Receives: 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. Receives: Device: UIHC Driving Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Error Rate
Measured: 1 year
Secondary outcomes (3)
Deceleration speed
Measured: 1 year
Time to braking
Measured: 1 year
Time to apply steering maneuvers
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start1 Nov 2014
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMT 1AStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerath U Nivedita
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jerath U Nivedita, University of Iowa
- Investigators
- Nivedita U. Jerath, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357355
- Sponsor's protocol ID
- 201307807
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2015
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Ability in Patients With CMT 1A
- ClinicalTrials.gov ID
- NCT02357355
- Acronym / sponsor ID
- 201307807
- Conditions
- CMT 1A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jerath U NiveditaUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 6 Feb 2015 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMT 1A Group | Active comparator | Device: UIHC Driving SimulatorPatients with CMT 1A will undergo a driving simulation study. The intervention will be the SIREN driving simulator. |
| Control Group | Active comparator | Device: UIHC Driving SimulatorPatients without CMT 1A who are our normal controls will undergo a driving simulation study. The intervention will be the SIREN driving simulator. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Have CMT 1A
- Have a valid driver's license
Key exclusion criteria (2 listed)
- History of other types of neuropathy (other than CMT 1A)
- History of blindness, seizures, or stroke, dementia/cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UIHC Driving SimulatorAlso: SIREN Driving SimulatorThis is a driving simulator located in the basement of the hospital. A car will be facing a large video screen of a driving simulation. | Device | CMT 1A Group, Control Group |
Primary outcome
Driving Error Rate
Time frame: 1 year
3 secondary outcomes
Deceleration speed
Time frame: 1 year
Time to braking
Time frame: 1 year
Time to apply steering maneuvers
Time frame: 1 year
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 10 Mar 2017.
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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.
Nivedita U. Jerath, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UIHC Driving Simulator in people with CMT 1A, run by Jerath U Nivedita 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 2 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 10 Mar 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?
Driving Error Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2017.