Essential TremorWMVIMNCT00906412
Ventrointermediate Nucleus (VIM DBS) and Working Memory
An observational study of Essential Tremor, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This is part of a larger study for which participants have already completed memory and thinking tests. In this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (ET) patients. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Nov 2016
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Washington University School of Medicine Movement Disorder Clinic
Who may be able to join
- ET PATIENTS:
- Clinical diagnosis of essential tremor affecting the upper extremities.
- Previous unilateral or bilateral DBS of the VIM
- Ages 40 -70
- A useable pre-surgical MR scan
- CONTROLS:
- Spouse or acquaintance of enrolled patient participant
- Ages 40 - 70
Who cannot join
- ET PATIENTS:
- Clinical evidence of other neurological conditions
- Significant psychiatric condition
- CONTROLS:
- Clinical evidence of other neurological conditions
- Significant psychiatric condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: VIM DBS and Working Memory
This is part of a larger study for which participants have already completed memory and thinking tests. In this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (ET) patients. We are especially trying to figure out how stimulation on each side of the brain may affect working memory.
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor
- Medical subject headings
- 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 |
|---|---|---|
| ET Group | Total of 25 participants with ET | |
| Controls | 25 controls without ET |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startSep 2006
- Primary completionSep 2013
- Study completionNov 2016
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 Washington University School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hershey Tamara, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906412
- Sponsor's protocol ID
- 06-0732
- Acronym
- WMVIM
- Status last verified
- Nov 2016
- First submitted
- 19 May 2009
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is a small pilot study and consent to share data was not obtained.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIM DBS and Working Memory
- ClinicalTrials.gov ID
- NCT00906412
- Acronym / sponsor ID
- WMVIM / 06-0732
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 May 2009 (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.
This is part of a larger study for which participants have already completed memory and thinking tests. In this study, investigators are trying to learn how deep-brain stimulation affects memory skills in essential tremor (ET) patients. We are especially trying to figure out how stimulation on each side of the brain may affect working memory.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET Group | – | –Total of 25 participants with ET |
| Controls | – | –25 controls without ET |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Washington University School of Medicine Movement Disorder Clinic
Key inclusion criteria (8 listed)
- Clinical diagnosis of essential tremor affecting the upper extremities.
- Previous unilateral or bilateral DBS of the VIM
- Ages 40 -70
- A useable pre-surgical MR scan
- Spouse or acquaintance of enrolled patient participant
Key exclusion criteria (6 listed)
- Clinical evidence of other neurological conditions
- Significant psychiatric condition
- Clinical evidence of other neurological conditions
- Significant psychiatric condition
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 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 Nov 2016.
- Individual participant dataSharing planned: No. This is a small pilot study and consent to share data was not obtained.
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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.
Hershey Tamara, PhD principal investigator
Washington University School of Medicine
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 Essential Tremor, run by Washington University School of Medicine 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 8 inclusion and 6 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 Nov 2016. 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 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.
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 Nov 2016.