Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by BrainboxTranscranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox
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.
Transcranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox: This condition will serve as the active control (sham stimulation).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Tremor amplitude — 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 Extracted from accelerometer data. The PCA component will be calculated by combining data from all three accelerometer axis (x, y and z). The power spectral density average of this PCA component will be calculated before (1min), during and after (1 min) stimulation. The primary outcome is the change in tremor amplitude (m/s²) across pre-, during-, and post-TUS conditions.
Tremor frequency — 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 Tremor frequency will be derived from the same one-dimensional signal obtained via principal component analysis (PCA) of the triaxial accelerometer data. The power spectral density (PSD) will be estimated using Welch's method for each recording segment (pre-TUS, during TUS, post-TUS).
The dominant tremor frequency will be defined as the frequency corresponding to the maximum PSD value within the predefined tremor band (e.g., 4-12 Hz) (expressed in Hz)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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