Cerebellar Research in Ultrasound Stimulation

Sponsor
KU Leuven
Study ID
NCT07508696
Status
Not Yet Recruiting

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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox — DEVICE
    This study will look at both physiological tremor in healthy volunteers and pathological tremor in ET patients. A set of parameters will be tested in healthy volunteers and the optimal combination of pulse repetition frequency (PRF) and pulse duration (PD) will be selected. A closed-loop system will also be tested where the timing of the ultrasound pulses is locked to the peak or the trough of the measured tremor and can adjust in real-time.
  • Transcranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox — DEVICE
    This condition will serve as the active control (sham stimulation).

Study Details

Experiment 1: Modulation of Physiological Tremor in Healthy Volunteers Thirty healthy volunteers will undergo TUS targeting the dentate nucleus in a randomized, double-blinded crossover design. Tremor amplitude, induced by a 15 g weight, will be measured using an accelerometer, and EEG will assess neural oscillations and cerebello-thalamo-cortical connectivity. Stimulation will include short-term (1 minute on/off for 12 minutes) and long-term (30 minutes) protocols, as well as closed-loop TUS for phase-specific effects. This experiment aims to optimize stimulation parameters and explore the dentate nucleus's role in tremor generation. Experiment 2: Tremor Modulation in Essential Tremor Patients Thirty ET patients will receive TUS targeting the dentate nucleus with optimized parameters from Experiment 1 in a randomized crossover design. The best protocol from previous experiment will be tested here. Tremor amplitude and EEG will be recorded to assess short- and long-term effects of TUS on pathological tremor.

Key Dates

First listed
Apr 2, 2026
Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: On-target to sham
    Participants in this arm will receive on-target stimulation first, followed by the sham condition
  • Experimental: Sham to on-target
    Participants in this arm will receive sham stimulation first, followed by the on-target stimulation

Primary Outcome Measure

Tremor amplitude [ Time Frame: Experiment 1 (short-term effects): 1-minute recording segments up to 10 minutes after stimulation, Experiment 1(long-term effects): Up to 30 minutes after stimulation Experiment 2 (Essential tremor): Up to 30 minutes after stimulation ]

Central Contacts

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