Cerebellar Research in Ultrasound Stimulation
Starting soon · Not applicable · Has a placebo group
Conditions studied: Essential Tremor
In brief
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 facts
- Study ID
- NCT07508696
- Run by
- KU Leuven
- People needed
- 60
- Starts
- 2026-06-01
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- BrainsHub — Leuven, Vlaams-Brabant, Belgium
Full record on ClinicalTrials.gov
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