Essential TremorNCT01978080
Continuous Tremor Assessment During Daily Activities
A study testing Kinesia HomeView in people with Essential Tremor, run by Great Lakes NeuroTechnologies Inc. at 2 sites in United States.
Trial summary
The specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Kinesia HomeView
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with essential tremor
- Currently taking medication to control tremor
Who cannot join
- Cognitive limitations that prevent comprehension or execution of study protocol
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: ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study
The specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone.
- Conditions
- Essential Tremor
- Being tested
- Kinesia HomeView
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesia HomeViewDevice
| Study group | Role | What they receive |
|---|---|---|
| Tremor reports provided | Experimental | Kinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician Receives: Device: Kinesia HomeView |
| Tremor reports not provided | Active comparator | Kinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician Receives: Device: Kinesia HomeView |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Change Scale score
Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment
Measured: End of Month 1, End of Month 2, End of Month 3
Secondary outcomes (3)
Clinical Global Impression-Severity Scale Score
Utilized to measure overall tremor severity
Measured: Enrollment, End of Month 1, End of Month 2, End of Month 3
Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale
Utilized to measure overall tremor severity
Measured: Enrollment, End of Month 1, End of Month 2, End of Month 3
Quality of Life in Essential Tremor Questionnaire
Utilized to measure the impact tremor has on overall quality of life
Measured: Enrollment, End of Month 1, End of Month 2, End of Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 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 Heldman, PhD, Principal investigator, Great Lakes NeuroTechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978080
- Sponsor's protocol ID
- 5R44AG034708-03
- Other IDs
- 5R44AG034708
- Status last verified
- Dec 2014
- First submitted
- 31 Oct 2013
- Last updated
- 10 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETSense: Adaptive Portable Essential Tremor Monitor - Symptomatic Impact Study
- ClinicalTrials.gov ID
- NCT01978080
- Acronym / sponsor ID
- 5R44AG034708-03
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 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
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 7 Nov 2013 (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 specific aim of this study is to evaluate if tremor severity and quality of life can be improved more using continuous home monitoring along with traditional assessments versus traditional assessments alone.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tremor reports provided | Experimental | Device: Kinesia HomeViewKinesia HomeView utilized to monitor tremor at home and reports provided to treating clinician |
| Tremor reports not provided | Active comparator | Device: Kinesia HomeViewKinesia HomeView utilized to monitor tremor at home and reports not provided to treating clinician |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with essential tremor
- Currently taking medication to control tremor
Key exclusion criteria (1 listed)
- Cognitive limitations that prevent comprehension or execution of study protocol
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 |
|---|---|---|
| Kinesia HomeView | Device | Tremor reports not provided, Tremor reports provided |
Primary outcome
Clinical Global Impression-Change Scale score
Time frame: End of Month 1, End of Month 2, End of Month 3
Utilized to measure any improvement or worsening of symptoms relative to a baseline state at enrollment
3 secondary outcomes
Clinical Global Impression-Severity Scale Score
Time frame: Enrollment, End of Month 1, End of Month 2, End of Month 3
Washington Heights Inwood Genetic Study of Essential Tremor (WHIGET) Tremor Rating Scale
Time frame: Enrollment, End of Month 1, End of Month 2, End of Month 3
Quality of Life in Essential Tremor Questionnaire
Time frame: Enrollment, End of Month 1, End of Month 2, End of Month 3
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 Dec 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.
Dustin Heldman, PhD principal investigator
Great Lakes NeuroTechnologies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesia HomeView in people with 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 2 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: finished, as of the sponsor's last update on 10 Dec 2014. 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?
Clinical Global Impression-Change Scale score (time frame: End of Month 1, End of Month 2, End of Month 3). 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 Dec 2014.