Essential Tremor
Conditions
Keywords
Brainsonix, tFUS, Focused Ultrasound, Tremor, Movement Disorder
Brief summary
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. Tremor severity will be assessed using clinician-rated scales (TETRAS and FTM), patient-reported quality-of-life measures (QUEST), and objective accelerometry before and after treatment sessions, with additional follow-up visits at one and three months post-treatment. MRI scans will be performed at baseline and after the final treatment session to monitor safety. The study aims to characterize whether non-ablative focused ultrasound can safely and transiently modulate tremor-related thalamic circuits and provide preliminary evidence supporting future controlled trials of LIFUP for ET.
Interventions
Participants will receive low-intensity focused ultrasound pulsation (LIFUP) delivered using the BrainSonix BX Pulsar 1002 investigational device targeting the ventral intermediate nucleus (Vim) of the thalamus.
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Label Pilot Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed clinical diagnosis of ET 2. Isolated tremor syndrome, at least 3 years duration 3. Subjective complaint of tremor assessed and validated by physician 4. Must be willing to comply with the study protocol 5. English Proficiency 6. At least 18 years of age 7. At most 90 years of age
Exclusion criteria
1. Severe microvascular disease or structural brain lesions equivalent to Fazekas scale of 3 or higher in the periventicular or deep white matter. 2. Subjects on blood thinning medications (e.g. Eliquis) 3. Recent stroke (within the last 6 months) 4. Implanted electrodes (e.g. DBS) in brain 5. History of aneurysm 6. History of cranial trauma resulting in fracture or traumatic brain injury 7. Subjects who are unable to cooperate with the testing. 8. Subjects who lack capacity to consent 9. Subjects with severe cardiac disease, increased intracranial pressure, or using a transcutaneous electrical nerve stimulation (TENS) unit. 10. 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 unstable angina, life-threatening arrhythmias, or use of an implantable cardioverter-defibrillator (ICD) iv) Uncontrolled hypertension (SBP \>180 mmHg or DBP \>110 mmHg) despite medication v) Any condition judged by the study physician to place the subject at increased risk from study participation 11. Subjects with implanted medical devices 12. Subjects with a history of seizure disorder. 13. Subjects with contraindications to enter MRI environment 14. Subjects with a history of substance abuse. 15. Subjects who are currently pregnant. This will be verified by a urine test prior to beginning the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accelerometric Data of Tremor Severity | From enrollment until the end of treatment at 2 weeks | Accelerometric trackers will be used to quantify and track tremor severity at each study session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TETRAS | From enrollment to the end of treatment at 2 weeks. | The Essential Tremor Rating Scale is a clinically verified scale to track the severity of tremor. |
| Fahn-Tolosa-Marin Tremor Rating Scale | From enrollment to the end of treatment at 2 weeks. | The Fahn-Tolosa-Marin Tremor Rating Scale is a clinically verified scale to track tremor severity. |
Countries
United States
Contacts
CONTACTAndrew Bishay
PRINCIPAL_INVESTIGATORWilliam Zeiger, MD, PhD
University of California, Los Angeles
Outcome results
None listed