Essential TremorNCT01334814
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
A study of Essential Tremor, run by Mayo Clinic.
Trial summary
The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Essential Tremor
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Jan 2010
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals with essential tremor who are at least 6 months status-post thalamic stimulator placement
- maintained a consistent chronic or intermittent stimulation schedule for at least 4 consecutive weeks prior to study enrollment
- no changes in stimulation parameters for at least 2 consecutive months prior to study enrollment
Who cannot join
- patients with clinically significant dementia (i.e., a score less than 24 out of 30 on the Mini Mental Status Exam14)
- women who are not post-menopausal
- patients with other significant neurological or psychiatric disease other than essential tremor
- patients treated with pallidotomy or thalamotomy
- patients with significant psychiatric disturbance as determined by Diagnostic and Statistical Manual-IV criteria which would make informed consent/cooperation problematic
About this study
The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation.
Read the detailed description
The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation. The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9. The study includes outcome measures of tremor, stimulation-induced side effects, sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.
- Conditions
- Essential Tremor
- Being tested
- Deep Brain Stimulation (Model 7438 Therapy Controller)
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (Model 7438 Therapy Controller)Device
Also called Model 7438 Therapy Controller
Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9.
Measured: 10 weeks
Secondary outcomes (2)
measures of tremor,voltage threshold for optimal tremor control
Measured: 10 weeks
Side effects
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startJan 2002
- Primary completionSep 2005
- Study completionJan 2010
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Ryan Uitti, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334814
- Sponsor's protocol ID
- 1324-02
- Status last verified
- Jan 2012
- First submitted
- 9 Mar 2010
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor
- ClinicalTrials.gov ID
- NCT01334814
- Acronym / sponsor ID
- 1324-02
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Apr 2011 (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 proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation.
Detailed description
The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation. The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9. The study includes outcome measures of tremor, stimulation-induced side effects, sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individuals with essential tremor who are at least 6 months status-post thalamic stimulator placement
- maintained a consistent chronic or intermittent stimulation schedule for at least 4 consecutive weeks prior to study enrollment
- no changes in stimulation parameters for at least 2 consecutive months prior to study enrollment
Key exclusion criteria (5 listed)
- patients with clinically significant dementia (i.e., a score less than 24 out of 30 on the Mini Mental Status Exam14)
- women who are not post-menopausal
- patients with other significant neurological or psychiatric disease other than essential tremor
- patients treated with pallidotomy or thalamotomy
- patients with significant psychiatric disturbance as determined by Diagnostic and Statistical Manual-IV criteria which would make informed consent/cooperation problematic
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 |
|---|---|---|
| Deep Brain Stimulation (Model 7438 Therapy Controller)Also: Model 7438 Therapy ControllerDeep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms | Device | – |
Primary outcome
sleep quality
Time frame: 10 weeks
The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9.
2 secondary outcomes
measures of tremor,voltage threshold for optimal tremor control
Time frame: 10 weeks
Side effects
Time frame: 10 weeks
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 6 Jan 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.
Ryan Uitti, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study of Essential Tremor, run by Mayo Clinic.
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 5 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 6 Jan 2012. 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?
sleep quality (time frame: 10 weeks). 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 6 Jan 2012.