Essential TremorNCT03875404
Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
A study testing Functional MRI in people with Essential Tremor, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI. 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?
- Functional MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 12 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement
- Age ≥ 18 years
Who cannot join
- Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor
- Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)
- Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.)
- Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.
- Conditions
- Essential Tremor
- Being tested
- Functional MRI
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional MRIDiagnostic test
A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation subjects | Experimental | Not described Receives: Diagnostic Test: Functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tremor rating score
Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor)
0 = None
- = Slight.
- = Moderate amplitude.
- = Marked amplitude
- = Severe amplitude
0 = Normal
- = Mildly abnormal.
- = Moderately abnormal.
- = Marked abnormal.
- = Severely abnormal.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start20 Mar 2019
- Primary completion31 Dec 2020
- Study completion12 Feb 2021
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik H. Middlebrooks, M.D., Mayo Clinic
- Investigators
- Erik H Middlebrooks, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875404
- Sponsor's protocol ID
- 18-010340
- Status last verified
- Sep 2021
- First submitted
- 8 Mar 2019
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
- ClinicalTrials.gov ID
- NCT03875404
- Acronym / sponsor ID
- 18-010340
- Conditions
- Essential Tremor
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 14 Mar 2019 (actual)
- 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.
Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation subjects | Experimental | Diagnostic Test: Functional MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement
- Age ≥ 18 years
Key exclusion criteria (5 listed)
- Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor
- Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.)
- Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.)
- Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device)
- Pregnant
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 |
|---|---|---|
| Functional MRIA special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain. | Diagnostic test | Deep Brain Stimulation subjects |
Primary outcome
Change in tremor rating score
Time frame: One year
Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor) 0 = None 1. = Slight. 2. = Moderate amplitude. 3. = Marked amplitude 4. = Severe amplitude 0 = Normal 1. = Mildly abnormal. 2. = Moderately abnormal. 3. = Marked abnormal. 4. = Severely abnormal.
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 17 Sep 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Erik H Middlebrooks principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional MRI in people with Essential Tremor, run by Mayo Clinic 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 2 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 17 Sep 2021. 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.
What does the primary outcome measure?
Change in tremor rating score (time frame: One year). 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 17 Sep 2021.