Essential TremorNCT01602042
Adaptive Portable Essential Tremor Monitor
An observational study of Essential Tremor, run by Great Lakes NeuroTechnologies Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Nov 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Essential tremor
Who may be able to join
- Aged 18 years or older
- Clinical diagnosis of essential tremor
- Able to provide informed consent
Who cannot join
- Significant medical or psychiatric illness
- Not capable of following the required clinical instructions
- Serious medical conditions that compromise safety
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: Phase II Study: Adaptive Portable Essential Tremor Monitor
The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.
- Conditions
- Essential Tremor
- Keywords
- essential tremor, motion sensors, tremor
- Medical subject headings
- Essential Tremor, Tremor
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor ratings during activities of daily living versus standardized tasks.
Measured: 10 hours each day the sensor is worn.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center, Baylor College of Medicine, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dustin A Heldman, PhD, Principal investigator, CleveMed Inc. also dba Great Lakes NeuroTechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602042
- Sponsor's protocol ID
- 2R44AG034708-02A1
- Status last verified
- Dec 2012
- First submitted
- 16 May 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Adaptive Portable Essential Tremor Monitor
- ClinicalTrials.gov ID
- NCT01602042
- Acronym / sponsor ID
- 2R44AG034708-02A1
- Conditions
- Essential Tremor
- Keywords
- essential tremor, motion sensors, tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Great Lakes NeuroTechnologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Rush University Medical Center, Baylor College of Medicine, National Institute on Aging (NIA)
- Study start
- May 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 18 May 2012 (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.
The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Essential tremor
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Clinical diagnosis of essential tremor
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Significant medical or psychiatric illness
- Not capable of following the required clinical instructions
- Serious medical conditions that compromise safety
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
Tremor ratings during activities of daily living versus standardized tasks.
Time frame: 10 hours each day the sensor is worn.
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 4 Dec 2012.
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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.
Dustin A Heldman, PhD principal investigator
CleveMed Inc. also dba Great Lakes NeuroTechnologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, run by Great Lakes NeuroTechnologies Inc. at 2 sites 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 3 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 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Tremor ratings during activities of daily living versus standardized tasks. (time frame: 10 hours each day the sensor is worn.). 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 4 Dec 2012.