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NCT07508696

Cerebellar Research in Ultrasound Stimulation

Sponsor: KU Leuven

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-01

Completion Date

2028-10-01

Last Updated

2026-04-02

Healthy Volunteers

Yes

Conditions

Essential Tremor

Interventions

DEVICE

Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox

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.

DEVICE

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

This condition will serve as the active control (sham stimulation).

Inclusion Criteria: * Experiment 1: Healthy Volunteers 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Participants aged 18-55 years 3. Male of female 4. Good health with no history of serious mental illness or implanted metal 5. Willingness to adhere to the TUS and MRI study schedule 6. Willingness to avoid caffeine and alcohol intake for at least 2 h prior to the investigation * Experiment 2: ET Patients 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Participants aged 18-75 years 3. Male of female 4. Diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist 5. Willingness to adhere to the TUS and MRI study schedule 6. Willingness to avoid caffeine and alcohol intake for at least 2 h prior to the investigation Exclusion Criteria: * Experiment 1: Healthy volunteers 1. Currently taking any psychotropic medication 2. Any head trauma resulting in loss of consciousness 3. Diagnosed with a serious mental illness 4. Alcohol or substance abuse or dependence (other than tobacco) in the past week 5. Currently in treatment for a psychiatric condition 6. Pregnancy (a test will be scheduled by the research team) 7. Personal or family history of seizures or epilepsy 8. Claustrophobia or inability to stay still in the MR scanner environment 9. Any metal in the body that is not MRI-compatible 10. Serious history of migraines 11. Hair in dreadlocks, braids, or weave (not possible to position ultrasound transducer) 12. orthopedic forearm or hand problems 13. Inability to adhere to the experimental schedule. * Experiment 2: ET Patients 1. Currently taking any psychotropic medication 2. Implanted with a non-MRI compatible medical device 3. History of thalamotomy 4. Skin lesions at stimulation site 5. Peripheral neuropathy 6. neurologic exam not consistent with ET 7. Any head trauma resulting in loss of consciousness 8. Diagnosed with a serious mental illness 9. Alcohol or substance abuse or dependence (other than tobacco) in the past week 10. alcohol or caffeine consumption within 12 hours of study enrollment. 11. Currently in treatment for a psychiatric condition 12. Pregnancy (scheduled test) 13. Personal or family history of seizures or epilepsy 14. Claustrophobia or inability to stay still in the MR scanner environment 15. Any metal in the body that is not MRI-compatible 16. Serious history of migraines 17. Hair in dreadlocks, braids, or weave 18. orthopedic forearm or hand problems 19. Inability to adhere to the experimental schedule.

Locations (1)

BrainsHub

Leuven, Vlaams-Brabant, Belgium