Cerebellar Research in Ultrasound Stimulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKU Leuven

About this trial

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.

Eligibility criteria

Qualifiers

Experiment 1: Healthy Volunteers

Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures

Participants aged 18-55 years

Male of female

Disqualifiers

Experiment 1: Healthy volunteers

Currently taking any psychotropic medication

Any head trauma resulting in loss of consciousness

Diagnosed with a serious mental illness

Trial design

Treatments tested in this trial

  • Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox
  • Transcranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators