Recruiting

Ultrasound Neuromodulation

Sponsor:

UCLA

Code:

NCT06610877

Conditions

Essential Tremor

Neuromodulation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Focused Ultrasound Neuromodulation - Sham Control

Focused ultrasound neuromodulation

Study Details

Brief summary:

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.

Conditions

Essential Tremor

Neuromodulation

Study ID

NCT06610877

Start date

Oct 1, 2024

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with medically refractory tremor scheduled to undergo MR-guided high-intensity focused ultrasound (HIFU) thalamotomy to treat their tremor at UCSF.

Exclusion Criteria:

  • Due to the logistical complexity of performing MRI in patients with MR-conditional pacemakers (need for device and patient monitoring), patients with pacemakers will be excluded from enrollment. All other patients undergoing HIFU thalamotomy for tremor will be eligible for enrollment.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Focused Ultrasound Neuromodulation - Sham Control

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Leo P. Sugrue, MD, PhD

415-353-9056leo.sugrue@ucsf.edu

Tommaso Di Ianni, PhD

tommaso.diianni@ucsf.edu

Locations

Pritzker Building, UCSF

Recruiting

San Francisco, California, United States, 94107

Contacts

Leo P. Sugrue, MD PhD

leo.sugrue@ucsf.edu

Tommaso Di Ianni, MD

tommaso.diianni@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • Essential Tremor
  • Neuromodulation
  • Focused Ultrasound
  • brain functional connectivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-03-06.