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New treatment option 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 investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting.
- 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 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, anticoagulant therapy, or inability to temporarily stop any antithrombotic medication
- Tremor disorders other than ET
- 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 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, anticoagulant therapy, or inability to temporarily stop any antithrombotic medication
- Tremor disorders other than ET
- 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
- History of drug or alcohol abuse
- Prior brain surgery such as Vim-FUSA, deep brain stimulation, and gamma knife thalamotomy
- Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA
- Skull density ratio lower than 0.4
- Does not qualify for FDA-approved clinical use based on current FDA labeling
- Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.