Parkinson's DiseaseNCT02523807
Tremor Monitoring Device
An observational study of Parkinson's Disease and Essential Tremor, run by Rambam Health Care Campus.
Trial summary
Patients with tremor may have varying degrees of tremor at different times. The amplitude and frequency of tremor may change. The investigators observational study is intended to document this tremor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Essential Tremor
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 30 Oct 2017
- 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: Patients with tremor due to Parkinson's disease or Essential tremor will be included
Who may be able to join
- Patients with tremor due to Parkinson's disease or Essential tremor
Who cannot join
- Severe dementia
About this study
Patients with tremor may have varying degrees of tremor at different times. The amplitude and frequency of tremor may change. The investigators observational study is intended to document this tremor.
- Conditions
- Parkinson's 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 |
|---|---|---|
| Patients with Parkinson's Disease | Patients with tremor due to Parkinson Disease | |
| Patients with Essential tremor | Patients with tremor due to Essential tremor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum linear acceleration of the forearm.
We will measure linear acceleration of the forearm in meter per second squared.
Measured: Linear acceleration of the forearm will be measured for 15-60 minutes.
Secondary outcomes (1)
Maximum angular velocity of the forearm.
We will measure angular velocityof the forearm in degrees per second.
Measured: Maximum angular velocity of the forearm will be measured for 15-60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Other
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, Ilana Schlesinger, Rambam Health Care Campus
- Investigators
- Ilana Schlesinger, M.D., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523807
- Sponsor's protocol ID
- 0486-14-RMB
- Status last verified
- Oct 2017
- First submitted
- 10 Aug 2015
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tremor Monitoring Device
- ClinicalTrials.gov ID
- NCT02523807
- Acronym / sponsor ID
- 0486-14-RMB
- Conditions
- Parkinson's Disease, Essential Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Sep 2015 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 14 Aug 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.
Patients with tremor may have varying degrees of tremor at different times. The amplitude and frequency of tremor may change. The investigators observational study is intended to document this tremor.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's Disease | – | –Patients with tremor due to Parkinson Disease |
| Patients with Essential tremor | – | –Patients with tremor due to Essential tremor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tremor due to Parkinson's disease or Essential tremor will be included
Key inclusion criteria (1 listed)
- Patients with tremor due to Parkinson's disease or Essential tremor
Key exclusion criteria (1 listed)
- Severe dementia
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
Maximum linear acceleration of the forearm.
Time frame: Linear acceleration of the forearm will be measured for 15-60 minutes.
We will measure linear acceleration of the forearm in meter per second squared.
1 secondary outcome
Maximum angular velocity of the forearm.
Time frame: Maximum angular velocity of the forearm will be measured for 15-60 minutes.
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 31 Oct 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.
Ilana Schlesinger, M.D. principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Essential Tremor, run by Rambam Health Care Campus.
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 1 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 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum linear acceleration of the forearm. (time frame: Linear acceleration of the forearm will be measured for 15-60 minutes.). 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 31 Oct 2017.