Essential TremorNCT02678429
Atlas Predicted DBS Settings in Essential Tremor
A study testing Change DBS programming in people with Essential Tremor, run by Vanderbilt University at 1 site in United States.
Trial summary
Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Change DBS programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 19 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor
Who cannot join
- Unable to use the patient handheld programmer
Trial locations and contacts
1 site in 1 country.
About this study
Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.
- Conditions
- Essential Tremor
- Being tested
- Change DBS programming
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change DBS programmingDevice
Patient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing
| Study group | Role | What they receive |
|---|---|---|
| DBS programming, standard of care | Active comparator | DBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas Receives: Device: Change DBS programming |
| DBS progamming from Atlas | Experimental | DBS settings determined from the a functional atlas first then change to settings determined by standard of care Receives: Device: Change DBS programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fahn-Tolusa-Marsden Tremor Rating Scale
Tremor quantification
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startSep 2016
- Primary completion19 Nov 2021
- Study completion19 Nov 2021
Why it stopped: Unable to fully enroll no data analysis planned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fenna Phibbs, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678429
- Sponsor's protocol ID
- 160155
- Status last verified
- Mar 2023
- First submitted
- 5 Feb 2016
- Last updated
- 27 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atlas Predicted DBS Settings in Essential Tremor
- ClinicalTrials.gov ID
- NCT02678429
- Acronym / sponsor ID
- 160155
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to fully enroll no data analysis planned
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 19 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 27 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Programming Deep Brain Stimulation for the treatment of Essential Tremor can be a time intensive process. Using an atlas created using functional tremor responses in the operating room to determine the optimal settings would lead to a faster response for the patient and improved quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS programming, standard of care | Active comparator | Device: Change DBS programmingDBS settings determined from the standard Neurologist symptomatic response first then change to settings from Atlas |
| DBS progamming from Atlas | Experimental | Device: Change DBS programmingDBS settings determined from the a functional atlas first then change to settings determined by standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Seleced for DBS of the VIM nucleus at Vanderbilt Medical center Diagnosis of essential tremor
Key exclusion criteria (1 listed)
- Unable to use the patient handheld programmer
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 |
|---|---|---|
| Change DBS programmingPatient will change their DBS settings to move from one DBS setting to the other, allowed one hour to adjust to the new setting prior to testing | Device | DBS progamming from Atlas, DBS programming, standard of care |
Primary outcome
Fahn-Tolusa-Marsden Tremor Rating Scale
Time frame: 1 month
Tremor quantification
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Essential Tremor
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change DBS programming in people with Essential Tremor, run by Vanderbilt University 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 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: stopped early, as of the sponsor's last update on 27 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fahn-Tolusa-Marsden Tremor Rating Scale (time frame: 1 month). 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 27 Mar 2023.