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Essential TremorCERBERUSNCT07508696

Cerebellar Research in Ultrasound Stimulation

A study testing Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox in people with Essential Tremor, run by KU Leuven at 1 site in Belgium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Essential Tremor
What is being tested?
Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBelgium
Study dates
1 Jun 2026to 1 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Robrecht W. Pieters, Master contact

+32 470 19 39 83

robrecht.pieters@kuleuven.be

Myles Mc Laughlin, Professor contact

+32 468 24 91 64

myles.mclaughlin@kuleuven.be

Belgium1 site
  • BrainsHub

    Leuven, Vlaams-Brabant, 3000

    Jessica Samogin, PhD, jessica.samogin@kuleuven.be

Other trials in Belgium

About this study

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.

Read the detailed description

Experiment 1: Modulation of Physiological Tremor in Healthy Volunteers This is a randomized, double-blinded, crossover study involving 30 healthy volunteers. Healthy volunteers will be recruited from campus with a flyer and using social media platforms. Each participant will undergo two conditions: on-target transcranial focused ultrasound stimulation (TUS) to the dentate nucleus and off-target (sham) stimulation. Initial screening will be performed via phone, after which an informed consent will be signed. The full experiment will consist of four separate visit days, of which only the first one will take place at the UZ Leuven department of Radiology. Visit days 2-4 will entirely be performed at the KU Leuven Brainshub facility in gebouw De Nayer.

  • Visit 1: Imaging On the first visit, participants will undergo MRI scans to obtain structural (T1-weighted) and Ultrashort Echo Time (UTE) MRI images. These scans will help reconstruct individual head models to estimate skull characteristics and optimize the TUS target engagement. Using the MRI data, simulations will be performed to calculate the optimal position, shape, size, and pressure of the ultrasound beam. This ensures precise targeting of the dentate nucleus on an individual level during subsequent stimulation sessions.
  • Visit 2: Immediate effects on Tremor Modulation and Phase Entrainment During this visit, participants will perform a task to induce physiological tremor (e.g., holding a weight on their finger). Tremor amplitude will be measured using an accelerometer. TUS will be applied in two conditions: on-target stimulation to the dentate nucleus and off-target sham stimulation. The stimulation will follow a short-term protocol (1 minute on, 1 minute off, repeated for 12 minutes). EEG will be recorded to assess changes in neural oscillations and phase entrainment in the cerebello-thalamo-cortical network. This visit aims to evaluate the immediate effects of TUS on tremor modulation and neural activity.
  • Visit 3: Prolonged effects on Tremor Modulation This visit will evaluate the long-term effects of TUS on tremor modulation. The stimulation protocol will be extended to 30 minutes of sonication to observe whether prolonged stimulation results in stronger or sustained tremor reduction. As in Visit 2, accelerometer data will be collected to measure tremor amplitude, and EEG will be recorded to monitor changes in brain activity over the extended stimulation period. The goal is to assess the durability of the effects and refine the optimal stimulation duration.
  • Visit 4: Closed-loop Stimulation for Tremor Suppression On the fourth visit, a closed-loop stimulation protocol will be tested. This involves synchronizing the TUS delivery to either the peak or trough of the tremor oscillation to determine whether phase-specific stimulation enhances tremor modulation. Real-time tremor data will be collected using an accelerometer, and EEG will be used to track neural responses. This visit aims to explore whether closed-loop TUS can provide more precise control over tremor amplitude compared to standard on/off stimulation.

Experiment 2: Tremor Modulation in Essential Tremor Patients Building on the results from Experiment 1, 30 ET patients will participate in a similar crossover design. Patients will be recruited by a neurologist collaborating on this project. The optimized TUS parameters from Experiment 1 will be used to target the dentate nucleus. The most optimal protocol for tremor reduction will be selected during this experiment. Thus, experiment 2 will exist of one visit day for imaging and another visit day to test the most optimal TUS protocol. Similarly, tremor amplitude will be measured using an accelerometer, and EEG will monitor neural activity during stimulation.

Being tested
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
Keywords
transcranial focused ultrasound stimulation, TUS, Essential Tremor, ET, Movement disorders, Neuromodulation, NIBS, non-invasive brain stimulation
Medical subject headings
Essential Tremor, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 BrainboxDevice

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

Study groups in NCT07508696
Study groupRoleWhat they receive
On-target to shamExperimentalParticipants in this arm will receive on-target stimulation first, followed by the sham condition
Receives: Device: Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox; Device: Transcranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox
Sham to on-targetExperimentalParticipants in this arm will receive sham stimulation first, followed by the on-target stimulation
Receives: Device: Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox; Device: Transcranial focused ultrasound delivered to the ventricles (control) using the NeuroFUS Pro by Brainbox

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tremor amplitude

    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.

    Measured: 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

  2. Tremor frequency

    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)

    Measured: 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

Secondary outcomes (3)
  1. EEG oscillatory activity

    Absolute and relative power change per band (post-TUS vs baseline, and vs sham/off-target). Power spectral density will be calculated and band-limited power will be extracted: Alpha (8-12 Hz), beta (13-30 Hz),Theta (4-8 Hz) and gamma (>30 Hz).

    Measured: Experiment 1 (short-term effects): 1-minute segments of on/off stimulation from 10 minutes before stimulation up until 10 minutes after stimulation Experiment 1 (long-term effects) & 2: 10 minutes before stimulation up until 30 minutes after stimulation

  2. EEG Phase

    EEG phase (radians) using Hilbert transform at the tremor frequency will be extracted per channel.

    Measured: Experiment 1 (short-term): During 1-minute segments of ON-stimulation Experiment 1 (long-term): During full 30-minute stimulation session. Experiment 2 (essential tremor): During full 30-minute stimulation session.

  3. Phase-Locking Value

    Alignment of the instantaneous phase of the EEG signal to TUS pulses (PRF). range 0-1 with 0 = random phase, 1 = perfect alignment

    Measured: Experiment 1 (short-term): During 1-minute segments of ON-stimulation Experiment 1 (long-term): During full 30-minute stimulation session. Experiment 2 (essential tremor): During full 30-minute stimulation session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Each participant will undergo two conditions: on-target transcranial focused ultrasound stimulation (TUS) to the dentate nucleus and off-target (sham) stimulation.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508696
Sponsor's protocol ID
S70171
Other IDs
1S82426N
Acronym
CERBERUS
Status last verified
Mar 2026
First submitted
19 Mar 2026
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial focused ultrasound delivered to the dentate nucleus using the NeuroFUS Pro by Brainbox in people with Essential Tremor, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robrecht W. Pieters, Master (+32 470 19 39 83, robrecht.pieters@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tremor amplitude (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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