Developing a New LIFU Neuromodulation Method to Suppress Tremor

NCT07103265 | Not Yet Recruiting Phase 2

• 1 other identifier: REB22-1437
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Change in power spectral density (PSD) of tremor accelerometric trace between post-sonication (Round 1) and baseline

  This outcome will be measured using triaxial accelerometry performed on the participants' index finger (treated side). Accelerometry will be analyzed by summing traces from each axis, after using Welch's method to calculate the power spectral density (PSD), with 3-7 Hz tremor frequency range selected for the area under the curve and transformed into logarithmic scale to account for the variability in tremor amplitude at baseline. The primary endpoint will be the percent change in PSD between the post-sonication recording after the 1st Round of the session and the baseline recording.

  5 minutes

Secondary Outcomes (3)

• Change in power spectral density (PSD) of tremor accelerometric trace between post-sonication (Round 2) and baseline

  5 minutes

• Change in Clinical Rating Scale for Tremor sub-score corresponding to the sum of scale items related to the treated side between the post-sonication rating and the baseline rating (participants with ET)

  5 minutes

• Change in the Movement Disorders Society-Unified Parkinson's Disease Rating Scale sub-score corresponding to the sum of resting tremor items of the scale between the post-sonication rating and the baseline rating (participants with PD).

  5 minutes

Study Arms (2)

Real stimulation

EXPERIMENTAL

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.

Device: Transcranial focused ultrasound stimulation

Sham stimulation

SHAM COMPARATOR

Same setting as Real stimulation, but without delivering any ultrasound stimulation.

Device: Sham stimulation

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 \*\*

Real stimulation

Sham stimulation DEVICE

Same set-up as for real stimulation but with without delivering any ultrasound stimulation

Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Essential Tremor OR Diagnosis of Parkinson's Disease

You may not qualify if:

• Presence of any neurological diagnosis other than Essential Tremor and Parkinson's Disease
• Family history of Essential Tremor OR Parkinson's Disease
• Inability to undergo MRI or attend to the experimental study sessions

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. Patients will be seated comfortably in a chair equipped with neuronavigation (BrainSight, Rogue) positioning the custom transcranial ultrasound (TUS) array. The TUS array will be applied to the scalp, with ultrasound gel applied, and held in place using the neuronavigation arm. The control session will have the same duration of the real stimulation session, i.e., it will be divided in two 40-minutes long rounds. During the first round, participants will receive sham stimulation which is unfocused, thereby providing the same sound but without sufficient intensity at any location. After the break, during the second round participants will receive TUS stimulation at the same energy parameters as in the real stimulation session but positioning the focus in the CSF space.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 5, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-06