Developing a New LIFU Neuromodulation Method to Suppress Tremor

Sponsor
University of Calgary
Study ID
NCT07103265
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Essential Tremor

Eligibility Criteria

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

Interventions

  • Transcranial focused ultrasound stimulation — DEVICE
    Parameters Range of values Fundamental frequency 250 kHz Transducer diameter 15 cm Focal distance 13.5 cm (steerable +/- 5-10 mm from the center) Pulse repetition frequency 100 Hz Duty cycle 10% Duration 2 min for each of the 7 foci Peak spatial intensity (Isppa) 10.0 W/cm2 Peak temporal average intensity (Ispta) 1.2 W/cm2 Mechanical index (MI) 0.48 \* Thermal index (TI) 0.8oC \*\*
  • Sham stimulation — DEVICE
    Same set-up as for real stimulation but with without delivering any ultrasound stimulation

Study Details

The investigators aim to apply low intensity focused ultrasound neuromodulation to patients with essential tremor to evaluate the efficacy of this intervention in reducing the amplitude of hand tremor compared to sham stimulation.

Key Dates

First listed
Aug 5, 2025
Start date
Sep 15, 2025
Status verified
Jun 2025
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Real stimulation
    We use an in-house developed focused ultrasound system that uses a 128-element phased array transducer (diameter of 135 mm, F#=0.8) operating at 700 kHz and mounted on a specialized arm for stereotactic neuronavigation. It has been tested in normal subjects targeting cortical structures (REB#19-1614, #21-0959), and in thalamus for the pilot data collection for this project (REB#22-1437). Patients will be seated comfortably in a chair equipped with neuronavigation (BrainSight, Rogue) positioning the custom LIFU array. The LIFU array will be applied to the scalp, with hair parted and ultrasound gel applied, and held in place using the neuronavigation arm.
  • Sham Comparator: Sham stimulation
    Same setting as Real stimulation, but without delivering any ultrasound stimulation.

Primary Outcome Measure

Change in power spectral density (PSD) of tremor accelerometric trace between post-sonication (Round 1) and baseline [ Time Frame: 5 minutes ]

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