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Cerebellar Research in Ultrasound Stimulation

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Source: NCT07508696, who can take part

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Trial details

Who runs it
KU Leuven
Trial code
NCT07508696
Record updated
2 April 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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; Good health with no history of serious mental illness or implanted metal; Willingness to adhere to the TUS and MRI study schedule; Willingness to avoid caffeine and alcohol intake for at least 2 h prior to the investigation; Experiment 2: ET Patients; Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures; Participants aged 18-75 years; Male of female; Diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist; Willingness to adhere to the TUS and MRI study schedule; Willingness to avoid caffeine and alcohol intake for at least 2 h prior to the investigation.

Exclusion: Experiment 1: Healthy volunteers; Currently taking any psychotropic medication; Any head trauma resulting in loss of consciousness; Diagnosed with a serious mental illness; Alcohol or substance abuse or dependence (other than tobacco) in the past week; Currently in treatment for a psychiatric condition; Pregnancy (a test will be scheduled by the research team); Personal or family history of seizures or epilepsy; Claustrophobia or inability to stay still in the MR scanner environment; Any metal in the body that is not MRI-compatible; Serious history of migraines; Hair in dreadlocks, braids, or weave (not possible to position ultrasound transducer); orthopedic forearm or hand problems; Inability to adhere to the experimental schedule; Experiment 2: ET Patients; Currently taking any psychotropic medication; Implanted with a non-MRI compatible medical device; History of thalamotomy; Skin lesions at stimulation site; Peripheral neuropathy; neurologic exam not consistent with ET; Any head trauma resulting in loss of consciousness; Diagnosed with a serious mental illness; Alcohol or substance abuse or dependence (other than tobacco) in the past week; alcohol or caffeine consumption within 12 hours of study enrollment; Currently in treatment for a psychiatric condition; Pregnancy (scheduled test); Personal or family history of seizures or epilepsy; Claustrophobia or inability to stay still in the MR scanner environment; Any metal in the body that is not MRI-compatible; Serious history of migraines; Hair in dreadlocks, braids, or weave; orthopedic forearm or hand problems; Inability to adhere to the experimental schedule.

ClinicalTrials.gov NCT07508696