Ultrasound Neuromodulation in Essential Tremor

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06610877
Status
Recruiting
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Conditions

  • Essential Tremor
  • Neuromodulation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Focused Ultrasound Neuromodulation - Sham Control — DEVICE
    Each ultrasound stimulation protocol will last for 60 seconds, consisting of 4 pulse trains of 5 seconds duration separated by 10 second intervals without stimulation. Across successive stimulation protocols (up to 25/patient) investigators will systematically vary pulse repetition frequency, duty cycle, and acoustic intensity to determine how these parameters contribute to the behavioral effect (transient tremor reduction). Parameters will be shuffled to control for group-level carry over effects. A defocusing lens will be in place during the session to test the difference between focused and unfoucused ultrasound while controlling for non-specific auditory and somatosensory confounds.
  • Focused ultrasound neuromodulation — DEVICE
    Each ultrasound stimulation protocol will last for 60 seconds, consisting of 4 pulse trains of 5 seconds duration separated by 10 second intervals without stimulation. Across successive stimulation protocols (up to 25/patient) investigators will systematically vary pulse repetition frequency, duty cycle, and acoustic intensity to determine how these parameters contribute to the behavioral effect (transient tremor reduction) in each patient. Parameters will be shuffled to control for group-level carry over effects and will include sham (unfocused or off-target stimulation) conditions to control for non-specific auditory confounds.

Study Details

This study is being done to test whether low-intensity focused ultrasound (LIFU) (low energy sound waves) cause temporary changes in brain activity and behavior when directed at particular parts of the brain. By targeting LIFU to the parts of the brain thought to be responsible for essential tremor (ET), and measuring any associated improvement in tremor, the investigators hope to show that LIFU can be a useful tool for studying the brain circuits responsible for tremor and other brain disorders.

Key Dates

Start date
Oct 1, 2024
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: To determine the most effective stimulation parameters for DRTT LIFU neuromodulation.
    Investigators will record wrist accelerometer signals while participants maintain standardized postures that maximally elicit their tremor before, during, and after delivering LIFU stimulation.
  • Sham Comparator: Defocusing lens
    This arm will be exactly the same as that of the active arm with the exception that a defocusing lens will be fitted to the ultrasound device which will cause the ultrasound energy to be dispersed rather than directed at the target structure.

Primary Outcome Measure

Reduction in tremor [ Time Frame: For 3 minutes immediately after the application of each sonication protocol ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pritzker Building, UCSFSan FranciscoCalifornia94107
Leo P. Sugrue, MD PhD
[email protected]
Tommaso Di Ianni, MD
[email protected]

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By research site
Pritzker Building, UCSF· San Francisco, CA

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