Parkinson DiseaseNCT00802191
WiiMote Game Controller as a Device to Study Movement Disorders
An observational study of Parkinson Disease and Essential Tremor, run by Vanderbilt University at 1 site in United States.
Trial summary
Purpose of the study: The purpose of this study is to investigate the Wii remote game control device for use in the study of Movement Disorders. The term "Movement Disorders" refers to a group of abnormal medical conditions characterized by involuntary body movements. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Essential Tremor
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18 Years and older, females of childbearing potential, healthy volunteers and adults with movement disorders.
Who may be able to join
- Men and women, aged 18 or older, with abnormal movements (including tremor, chorea, dystonia, myoclonus, and tic) and normal controls (subjects without abnormal movements).
- Subjects must be willing and able to comply with study procedures.
- Patients must be willing and able to give meaningful, written informed consent.
Who cannot join
- 1. Significant cognitive impairment which, in the opinion of the Investigator, would interfere with the ability to complete all the tests required in the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2551
About this study
Purpose of the study:
The purpose of this study is to investigate the Wii remote game control device for use in the study of Movement Disorders. The term "Movement Disorders" refers to a group of abnormal medical conditions characterized by involuntary body movements. Current treatment of these disorders is primarily geared to improve symptoms. Rating scales are usually used to grade response to treatment. These rating scales require special training, take a lot of time, and often present with great variability. Thus, the development of a simple device to perform efficacy measurements offers a great advantage over current methods and is less costly.
Read the detailed description
The expected length of taking part in this study will depend on whether or not subjects are chosen for a group to look at the reproducibility of the data collected from the Wii remote. If subjects agree to take part in the study, basic data including age, gender, ethnicity, and medications will be collected. If subjects have been diagnosed with a movement disorder, that diagnosis will also be recorded. This data will be secured in a HIPAA compliant computer system and recorded data will be given a unique random code. During the Wii remote portion of the study, subjects will be asked to hold the Wii remote controller in several different positions and perform various movements with the controller.
These include:
- Holding the controller still with the elbow straight and then the elbow bent.
- Tapping the control button as fast as you can.
- Rotation of your wrist as fast as you can.
- Bending at the wrist and at the elbow as fast as you can.
- Walking 30 feet.
- Attaching the controller to your arm with a Velcro strap and repeating the motions performed while holding the controller.
These maneuvers will be done first with the right and then the left hand. We expect that this series will take about 5 minutes.
If subjects have Parkinson's disease they will also be asked to undergo Part III (Motor Sub-Scale) of the Unified Parkinson's Disease Rating Scale. This scale measures various aspects such as finger tapping, hand opening and closing and walking on a scale of 0 - 4. We expect that this portion of the examination will take about 5 minutes.
If subjects carry the diagnosis of Essential Tremor, they will be asked to undergo Standard Measure of EssentialTremor that includes drawing of spirals and pouring of water from one glass to another. Again, we estimate that this scale will take about 5 minutes.
If subjects carry the diagnosis of Parkinson's disease or Essential Tremor and have deep brain stimulation surgery, results of using the Wii™ Remote game controller (handheld or attached using a Velcro strap) will be done during a clinical programming appointment. The information obtained will not be used for any clinical use and will not interfere with the normal standard of care.
A sub-set of patients will be asked to repeat these measures at various times to see if there is either a learning curve, or if the measures are repeatable over time. Subjects may decline this at any point in time.
- Conditions
- Parkinson Disease, Essential Tremor
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Participants with no movement disorders. | |
| Movement Disorders Participants | Participants have a movement disorder |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startAug 2007
- Primary completionMay 2013
- Study completionAug 2014
Why it stopped: Lack of study participants, no data published.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Parkinson Foundation, Robertson County Parkinson Support Group
- Responsible party
- Principal investigator, Thomas L Davis, Vanderbilt University
- Investigators
- Thomas L Davis, MD, Principal investigator, Department of Neurology/Movement Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802191
- Sponsor's protocol ID
- TDavis Wii
- Status last verified
- Aug 2014
- First submitted
- 2 Dec 2008
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WiiMote Game Controller as a Device to Study Movement Disorders
- ClinicalTrials.gov ID
- NCT00802191
- Acronym / sponsor ID
- TDavis Wii
- Conditions
- Parkinson Disease, Essential Tremor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of study participants, no data published.
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Parkinson Foundation, Robertson County Parkinson Support Group
- Study start
- Aug 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Dec 2008 (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.
Purpose of the study:
The purpose of this study is to investigate the Wii remote game control device for use in the study of Movement Disorders. The term "Movement Disorders" refers to a group of abnormal medical conditions characterized by involuntary body movements. Current treatment of these disorders is primarily geared to improve symptoms. Rating scales are usually used to grade response to treatment. These rating scales require special training, take a lot of time, and often present with great variability. Thus, the development of a simple device to perform efficacy measurements offers a great advantage over current methods and is less costly.
Detailed description
The expected length of taking part in this study will depend on whether or not subjects are chosen for a group to look at the reproducibility of the data collected from the Wii remote. If subjects agree to take part in the study, basic data including age, gender, ethnicity, and medications will be collected. If subjects have been diagnosed with a movement disorder, that diagnosis will also be recorded. This data will be secured in a HIPAA compliant computer system and recorded data will be given a unique random code. During the Wii remote portion of the study, subjects will be asked to hold the Wii remote controller in several different positions and perform various movements with the controller.
These include:
- Holding the controller still with the elbow straight and then the elbow bent.
- Tapping the control button as fast as you can.
- Rotation of your wrist as fast as you can.
- Bending at the wrist and at the elbow as fast as you can.
- Walking 30 feet.
- Attaching the controller to your arm with a Velcro strap and repeating the motions performed while holding the controller.
These maneuvers will be done first with the right and then the left hand. We expect that this series will take about 5 minutes.
If subjects have Parkinson's disease they will also be asked to undergo Part III (Motor Sub-Scale) of the Unified Parkinson's Disease Rating Scale. This scale measures various aspects such as finger tapping, hand opening and closing and walking on a scale of 0 - 4. We expect that this portion of the examination will take about 5 minutes.
If subjects carry the diagnosis of Essential Tremor, they will be asked to undergo Standard Measure of EssentialTremor that includes drawing of spirals and pouring of water from one glass to another. Again, we estimate that this scale will take about 5 minutes.
If subjects carry the diagnosis of Parkinson's disease or Essential Tremor and have deep brain stimulation surgery, results of using the Wii™ Remote game controller (handheld or attached using a Velcro strap) will be done during a clinical programming appointment. The information obtained will not be used for any clinical use and will not interfere with the normal standard of care.
A sub-set of patients will be asked to repeat these measures at various times to see if there is either a learning curve, or if the measures are repeatable over time. Subjects may decline this at any point in time.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Participants with no movement disorders. |
| Movement Disorders Participants | – | –Participants have a movement disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 Years and older, females of childbearing potential, healthy volunteers and adults with movement disorders.
Key inclusion criteria (3 listed)
- Men and women, aged 18 or older, with abnormal movements (including tremor, chorea, dystonia, myoclonus, and tic) and normal controls (subjects without abnormal movements).
- Subjects must be willing and able to comply with study procedures.
- Patients must be willing and able to give meaningful, written informed consent.
Key exclusion criteria (1 listed)
- 1. Significant cognitive impairment which, in the opinion of the Investigator, would interfere with the ability to complete all the tests required in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of study participants, no data published.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
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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.
Thomas L Davis, MD principal investigator
Department of Neurology/Movement Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Essential Tremor, run by Vanderbilt University 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Sep 2014. 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 was stopped early (reason given: Lack of study participants, no data published.). Results are not available in the source record.
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.
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 1 Sep 2014.