Clinical trial for Essential Tremor
Official title 3-D Tractography FUS Ablation for Essential Tremor
ClinicalTrials.gov ID: NCT06331052
What this study is testing
- What it's testing
- The study wants to find out if using 3‑D tractography makes the ultrasound ablation of the brain more accurate and safe compared with the usual method.
- Who it's for
- Adults who have essential tremor and are candidates for brain ablation.
- What's involved
- Participants will have a focused‑ultrasound procedure that uses MRI to watch the treatment and will undergo imaging and check‑ups before and after the procedure.
- Time commitment
- A single treatment session with several clinic visits for screening, the procedure, and follow‑up appointments over a few weeks.
This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians
- Symptoms refractory to at least two medications
- Stable essential tremor medication regimen for at least 4 weeks prior to screening
- Willing and able to participate in all follow-up visits
- Willing and able to undergo MR imaging.
You likely can't join if
- Uncontrolled hypertension
- Medically unstable coronary artery disease
- Coagulopathy with inability to temporarily stop any antithrombotic medication
- Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of...
- Unwilling or unable to undergo tremor surgery while awake
- Significant and non-correctible motion artifact in imaging
See the full eligibility criteria
- Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians
- Symptoms refractory to at least two medications
- Stable essential tremor medication regimen for at least 4 weeks prior to screening
- Willing and able to participate in all follow-up visits
- Willing and able to undergo MR imaging.
- Uncontrolled hypertension
- Medically unstable coronary artery disease
- Coagulopathy with inability to temporarily stop any antithrombotic medication
- Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of abstinence etc.)
- Unwilling or unable to undergo tremor surgery while awake
- Significant and non-correctible motion artifact in imaging
- Pregnant at the time of enrollment or preoperative evaluation
- Dementia
- History of psychosis
- Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation
- Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA
- does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio ≤ 0.4 will be allowed for this study
- Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.
- non-English speaking
The study team makes the final eligibility decision.
Where it is enrolling
- Chapel Hill, North Carolina, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chapel Hill, North Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.