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New treatment option for Essential Tremor
Official title Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor
ClinicalTrials.gov ID: NCT07599592
What this study is testing
- What it's testing
- This open-label pilot study will evaluate the safety, tolerability, feasibility, and preliminary efficacy of repeated low-intensity focused ultrasound pulsation (LIFUP) targeting the ventral intermediate nucleus (Vim) of the thalamus in patients with Essential Tremor (ET). Twelve adults with clinically diagnosed ET will undergo six LIFUP treatment sessions over approximately two weeks using the BrainSonix BX Pulsar 1002 system.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Confirmed clinical diagnosis of ET
- Isolated tremor syndrome, at least 3 years duration
- Subjective complaint of tremor assessed and validated by physician
- Must be willing to comply with the study protocol
- English Proficiency
You likely can't join if
- Severe microvascular disease or structural brain lesions equivalent to Fazekas scale of 3 or higher in the periventicular or deep white matter.
- people on blood thinning medications (e.g. Eliquis)
- Recent stroke (within the last 6 months)
- Implanted electrodes (e.g. DBS) in brain
- History of aneurysm
- History of cranial trauma resulting in fracture or traumatic brain injury
See the full eligibility criteria
- Confirmed clinical diagnosis of ET
- Isolated tremor syndrome, at least 3 years duration
- Subjective complaint of tremor assessed and validated by physician
- Must be willing to comply with the study protocol
- English Proficiency
- At least 18 years of age
- At most 90 years of age
- Severe microvascular disease or structural brain lesions equivalent to Fazekas scale of 3 or higher in the periventicular or deep white matter.
- people on blood thinning medications (e.g. Eliquis)
- Recent stroke (within the last 6 months)
- Implanted electrodes (e.g. DBS) in brain
- History of aneurysm
- History of cranial trauma resulting in fracture or traumatic brain injury
- people who are unable to cooperate with the testing.
- people who lack capacity to consent
- people with severe cardiac disease, increased intracranial pressure, or using a transcutaneous electrical nerve stimulation (TENS) unit.
- Severe cardiac disease will be defined as any of the following: i) History of myocardial infarction within the past 6 months ii) Diagnosis of congestive heart failure with NYHA Class III or IV symptoms iii) History of...
- people with implanted medical devices
- people with a history of seizure disorder.
- people with contraindications to enter MRI environment
- people with a history of substance abuse.
- people who are currently pregnant. This will be verified by a urine test prior to beginning the study.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, 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.