Essential TremorTremorTISNCT07531238
Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor
A study testing Transcranial temporal interference stimulation and Tremor monitoring through Inertial Measurement Units (IMUs) in people with Essential Tremor, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The goal of this proof-of-concept study is to examine the effects of a relatively new, non-invasive electrical current-based technique, transcranial temporal interference stimulation (tTIS), in patients with Essential Tremor (ET). TTIS is delivered via a Digitimer Ltd. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Transcranial temporal interference stimulation and Tremor monitoring through Inertial Measurement Units (IMUs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 May 2026to May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject;
- Age ≥ 18 years;
- Diagnosis of Essential Tremor (ET) based on the proposed criteria by the Movement Disorders Society;
- Candidate for MRgHIFU thalamotomy
Who cannot join
- Unable to provide informed consent;
- Severe sensory or cognitive impairment or musculoskeletal dysfunction that prohibits understanding instructions or performing the experimental tasks.
- Only for patients undergoing the tTIS protocol (experimental arm):
- Severe neuropsychiatric (e.g., major depression, severe dementia, psychosis) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life-threatening infectious disease);
- Inability to follow or non-compliance with the procedures of the study;
- Contraindications for non-invasive brain stimulation:
- Electronic or ferromagnetic medical implants or devices
- History of seizures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University of Geneva (UNIGE)
Geneva, 1205
Christian Lüscher, Full Professor, +41 22 379 54 44, christian.luscher@unige.ch
Vanessa Fleury, Privat Docent, +41 22 372 83 37, vanessa.fleurynissen@hug.ch
About this study
Official title: Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor: A Single-Center, Proof-of-Concept Study (TremorTIS (Pilot))
The goal of this proof-of-concept study is to examine the effects of a relatively new, non-invasive electrical current-based technique, transcranial temporal interference stimulation (tTIS), in patients with Essential Tremor (ET). TTIS is delivered via a Digitimer Ltd. stimulator, the "DS5 Isolated Bipolar Constant Current Stimulator." The method enables targeting deep cerebral structures to selectively modulate neurons. The structure of interest in the present study is the ventralis intermedius (VIM) of the thalamus, which plays a key role in tremor generation in people with essential tremor. Therefore, techniques targeting the VIM nucleus can potentially improve the tremor and the quality of life in the long term, as is the case with MRI-guided high-intensity focused ultrasound (MRgHIFU). Despite its efficiency, MRgHIFU can lead to side effects that could benefit from improved predictive modeling. In our proof-of-concept study, the investigators aim to examine whether tTIS of the VIM nucleus can alter tremor characteristics and, therefore, mimic the effects of MRgHIFU. This work would pave the way for future clinical trials to design prediction tools for MRgHIFU if the investigators can demonstrate the positive impact of tTIS.
Read the detailed description
Essential tremor (ET) represents one of the most common movement disorders worldwide, with an estimated prevalence of 1 % across all ages, increasing with age. Despite being considered a benign disease, it can nevertheless lead to significant functional impairment. Several drugs, such as beta-blockers, can be used to alleviate the tremor, but they may not be enough to improve the quality of life, and they can cause significant side effects.
The etiology and pathophysiology of ET are not yet fully understood. One pathophysiological hypothesis for ET is a deficiency in cerebellar GABAergic transmission, leading to abnormal oscillatory activity that interferes with motor function. This abnormal oscillatory activity converges on the thalamus, specifically in the ventralis intermedius (VIM) nucleus. Various surgical or disruptive medical techniques can target this nucleus in case of a drug-resistant tremor or drug intolerance.
One such technique is MRI-guided, high-intensity focused ultrasound thalamotomy (MRgHIFU), which results in a long-lasting, significant reduction of tremor in most cases. Despite the MRgHIFU's millimetric precision, the VIM is not directly visible on peri-operative MRI scans. MRgHIFU thalamotomy can also lead to side effects, such as modifications of sensations (paresthesia), speech difficulties (dysarthria), imbalance (ataxia), or even motor deficits (hemiparesis). Therefore, more accurate tools are needed to predict the effects of MRgHIFU.
One promising technique that could help clinicians predict the effects of MRgHIFU is transcranial temporal interference stimulation. This non-invasive neuromodulation technique uses two pairs of scalp electrodes, which deliver two slightly different high-frequency currents (e.g., f1 = 2.00 kHz; f2 = 2.01 kHz). Frequencies in the kHz range are too high to induce an effect on neurons and nerves. Still, due to their difference Δf = f2-f1, they both interfere in the depth of the brain to create a so-called amplitude-modulated envelope with a beat frequency falling in the physiological range (e.g., Δf = 10 Hz). This allows neuromodulation of deep structures-the VIM in this study-and avoids stimulation of the cortical structures at the same time. The investigators will use the Digitimer Ltd. "DS5 Isolated Bipolar Constant Current Stimulator" to deliver tTIS.
The goal of the proposed proof-of-concept study is to examine the effects of tTIS on tremor modulation in essential tremor patients who are candidates for MRgHIFU thermoablation of the VIM, and to compare the impact of tTIS with the "true" effect of tremor reduction after MRgHIFU. The primary outcome will be the change in tremor amplitude (in mm), as measured by Inertial Measurement Units (IMUs) comprising an accelerometer, a gyroscope, and a magnetometer. The secondary outcomes will be other quantitative tremor parameters, such as the frequency, angular and linear acceleration, and power, as well as safety outcomes.
- Conditions
- Essential Tremor
- Being tested
- Transcranial temporal interference stimulation, Tremor monitoring through Inertial Measurement Units (IMUs)
- Keywords
- Transcranial temporal interference stimulation, Neuromodulation, Essential Tremor, Nucleus ventralis intermedius
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial temporal interference stimulationDevice
We will deliver transcranial temporal interference stimulation (tTIS) via the DS5 stimulator (Digitimer Ltd.) in patients with essential tremor who are candidates for MRgHIFU to examine its ability to modulate the tremor amplitude.
Tremor monitoring through Inertial Measurement Units (IMUs)Other
Essential tremor patients candidates for MRgFUS, whether undergoing the tTIS protocol (experimental arm) or acting as controls (control arm), will undergo a tremor quantification through Inertial Measurement Units (IMUs) before, during, and after the stimulation (for the experimental arm), as well as before and after MRgHIFU (both arms).
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: tTIS stimulation protocol | Experimental | In this arm, patients with essential tremor who are candidates for MRgHIFU will undergo the tTIS stimulation protocol before MRgHIFU. The tremor changes will be monitored using Inertial Measurement Units (IMUs) during the tTIS, as well as after tTIS and MRgHIFU. Receives: Device: Transcranial temporal interference stimulation; Other: Tremor monitoring through Inertial Measurement Units (IMUs) |
| Control arm: Tremor Monitoring | Other | In this arm, essential tremor patients who are candidates for MRgHIFU will undergo only tremor monitoring using Inertial Measurement Units (IMUs) before and after MRgHIFU. Receives: Other: Tremor monitoring through Inertial Measurement Units (IMUs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor amplitude
Tremor amplitude, measured in mm in the 3 axes, using an Inertial Measurement Unit (IMU) secured on the dorsum of both hands of the essential tremor patient.
Measured: From enrollment to day 1 (D1) after MRgHIFU
Secondary outcomes (8)
Tremor peak frequency
Peak (dominant) frequency of the tremor in Hz
Measured: From enrollment to day 1 (D1) post-MRgHIFU
Frequency Width Half Maximum (FWHM)
Frequency Width Half Maximum (FWHM) in Hz, i.e., the frequency bandwidth where the power spectrum's value is at least half of its maximum value
Measured: From enrollment to day 1 (D1) post-MRgHIFU
Tremor Stability Index (TSI)
Tremor Stability Index (TSI), i.e., the interquartile range of the change in frequency (Δf), indicating the cycle-to-cycle variations of tremor
Measured: From enrollment to day 1 (D1) post-MRgHIFU
Power of the tremor
Power band spectrum, measured in dB, derived from the three-dimensional data of the IMU
Measured: From enrollment to day 1 (D1) post-MRgHIFU
Half-Width Power (HWP)
Half-Width Power (HWP), .i.e., the power referring to the frequency bandwidth where the power spectrum remains at least half of its maximum, calculated as the area under the spectral curve between two vertical straight lines intersecting the rising and falling edge of the peak at half of the peak power (full-width half maximum), in the main frequency band of interest
Measured: From enrollment to day 1 (D1) post-MRgHIFU
Linear acceleration of tremor
Linear acceleration in 3 dimensions (measured in m/s^2 through the accelerometer component of the IMU)
Measured: From enrollment to day 1 (D1) post-MRgHIFU
Angular velocity of tremor
Angular velocity in 3 axes, measured in degrees per second (°/s), through the gyroscope component
Measured: From enrollment to day 1 (D1) post-MRgHIFU
Incidence of Device-Emergent (Serious) Adverse Events [Safety]
Only for the experimental arm (tTIS protocol): safety will be assessed through the number of (severe) adverse events (SAEs/AEs) possibly, probably, or definitely related to the study device.
Measured: From enrollment to day 1 (D1) post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start26 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, Wyss Center for Bio and Neuroengineering
- Responsible party
- Principal investigator, Vanessa Fleury, University Hospital, Geneva
- Investigators
- Christian Lüscher, Full Professor, Principal investigator, Department of Basic Neuroscience, University of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531238
- Sponsor's protocol ID
- BASEC 2025-D0091
- Acronym
- TremorTIS
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including demographic data, clinical characteristics, and quantitative tremor assessment data, will be shared. Data will be available upon reasonable request to the corresponding author after publication of the primary results, in accordance with ethical approval and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor: A Single-Center, Proof-of-Concept Study (TremorTIS (Pilot))
- ClinicalTrials.gov ID
- NCT07531238
- Acronym / sponsor ID
- TremorTIS / BASEC 2025-D0091
- Conditions
- Essential Tremor
- Keywords
- Transcranial temporal interference stimulation, Neuromodulation, Essential Tremor, Nucleus ventralis intermedius
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland, Wyss Center for Bio and Neuroengineering
- Study start
- 26 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this proof-of-concept study is to examine the effects of a relatively new, non-invasive electrical current-based technique, transcranial temporal interference stimulation (tTIS), in patients with Essential Tremor (ET). TTIS is delivered via a Digitimer Ltd. stimulator, the "DS5 Isolated Bipolar Constant Current Stimulator." The method enables targeting deep cerebral structures to selectively modulate neurons. The structure of interest in the present study is the ventralis intermedius (VIM) of the thalamus, which plays a key role in tremor generation in people with essential tremor. Therefore, techniques targeting the VIM nucleus can potentially improve the tremor and the quality of life in the long term, as is the case with MRI-guided high-intensity focused ultrasound (MRgHIFU). Despite its efficiency, MRgHIFU can lead to side effects that could benefit from improved predictive modeling. In our proof-of-concept study, the investigators aim to examine whether tTIS of the VIM nucleus can alter tremor characteristics and, therefore, mimic the effects of MRgHIFU. This work would pave the way for future clinical trials to design prediction tools for MRgHIFU if the investigators can demonstrate the positive impact of tTIS.
Detailed description
Essential tremor (ET) represents one of the most common movement disorders worldwide, with an estimated prevalence of 1 % across all ages, increasing with age. Despite being considered a benign disease, it can nevertheless lead to significant functional impairment. Several drugs, such as beta-blockers, can be used to alleviate the tremor, but they may not be enough to improve the quality of life, and they can cause significant side effects.
The etiology and pathophysiology of ET are not yet fully understood. One pathophysiological hypothesis for ET is a deficiency in cerebellar GABAergic transmission, leading to abnormal oscillatory activity that interferes with motor function. This abnormal oscillatory activity converges on the thalamus, specifically in the ventralis intermedius (VIM) nucleus. Various surgical or disruptive medical techniques can target this nucleus in case of a drug-resistant tremor or drug intolerance.
One such technique is MRI-guided, high-intensity focused ultrasound thalamotomy (MRgHIFU), which results in a long-lasting, significant reduction of tremor in most cases. Despite the MRgHIFU's millimetric precision, the VIM is not directly visible on peri-operative MRI scans. MRgHIFU thalamotomy can also lead to side effects, such as modifications of sensations (paresthesia), speech difficulties (dysarthria), imbalance (ataxia), or even motor deficits (hemiparesis). Therefore, more accurate tools are needed to predict the effects of MRgHIFU.
One promising technique that could help clinicians predict the effects of MRgHIFU is transcranial temporal interference stimulation. This non-invasive neuromodulation technique uses two pairs of scalp electrodes, which deliver two slightly different high-frequency currents (e.g., f1 = 2.00 kHz; f2 = 2.01 kHz). Frequencies in the kHz range are too high to induce an effect on neurons and nerves. Still, due to their difference Δf = f2-f1, they both interfere in the depth of the brain to create a so-called amplitude-modulated envelope with a beat frequency falling in the physiological range (e.g., Δf = 10 Hz). This allows neuromodulation of deep structures-the VIM in this study-and avoids stimulation of the cortical structures at the same time. The investigators will use the Digitimer Ltd. "DS5 Isolated Bipolar Constant Current Stimulator" to deliver tTIS.
The goal of the proposed proof-of-concept study is to examine the effects of tTIS on tremor modulation in essential tremor patients who are candidates for MRgHIFU thermoablation of the VIM, and to compare the impact of tTIS with the "true" effect of tremor reduction after MRgHIFU. The primary outcome will be the change in tremor amplitude (in mm), as measured by Inertial Measurement Units (IMUs) comprising an accelerometer, a gyroscope, and a magnetometer. The secondary outcomes will be other quantitative tremor parameters, such as the frequency, angular and linear acceleration, and power, as well as safety outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: tTIS stimulation protocol | Experimental | Device: Transcranial temporal interference stimulation, Other: Tremor monitoring through Inertial Measurement Units (IMUs)In this arm, patients with essential tremor who are candidates for MRgHIFU will undergo the tTIS stimulation protocol before MRgHIFU. The tremor changes will be monitored using Inertial Measurement Units (IMUs) during the tTIS, as well as after tTIS and MRgHIFU. |
| Control arm: Tremor Monitoring | Other | Other: Tremor monitoring through Inertial Measurement Units (IMUs)In this arm, essential tremor patients who are candidates for MRgHIFU will undergo only tremor monitoring using Inertial Measurement Units (IMUs) before and after MRgHIFU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed Consent signed by the subject;
- Age ≥ 18 years;
- Diagnosis of Essential Tremor (ET) based on the proposed criteria by the Movement Disorders Society;
- Candidate for MRgHIFU thalamotomy
Key exclusion criteria (8 listed)
- Unable to provide informed consent;
- Severe sensory or cognitive impairment or musculoskeletal dysfunction that prohibits understanding instructions or performing the experimental tasks.
- Severe neuropsychiatric (e.g., major depression, severe dementia, psychosis) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life-threatening infectious disease);
- Inability to follow or non-compliance with the procedures of the study;
- Contraindications for non-invasive brain stimulation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial temporal interference stimulationWe will deliver transcranial temporal interference stimulation (tTIS) via the DS5 stimulator (Digitimer Ltd.) in patients with essential tremor who are candidates for MRgHIFU to examine its ability to modulate the tremor amplitude. | Device | Experimental arm: tTIS stimulation protocol |
| Tremor monitoring through Inertial Measurement Units (IMUs)Essential tremor patients candidates for MRgFUS, whether undergoing the tTIS protocol (experimental arm) or acting as controls (control arm), will undergo a tremor quantification through Inertial Measurement Units (IMUs) before, during, and after the stimulation (for the experimental arm), as well as before and after MRgHIFU (both arms). | Other | Control arm: Tremor Monitoring, Experimental arm: tTIS stimulation protocol |
Primary outcome
Tremor amplitude
Time frame: From enrollment to day 1 (D1) after MRgHIFU
Tremor amplitude, measured in mm in the 3 axes, using an Inertial Measurement Unit (IMU) secured on the dorsum of both hands of the essential tremor patient.
8 secondary outcomes
Tremor peak frequency
Time frame: From enrollment to day 1 (D1) post-MRgHIFU
Frequency Width Half Maximum (FWHM)
Time frame: From enrollment to day 1 (D1) post-MRgHIFU
Tremor Stability Index (TSI)
Time frame: From enrollment to day 1 (D1) post-MRgHIFU
Power of the tremor
Time frame: From enrollment to day 1 (D1) post-MRgHIFU
Half-Width Power (HWP)
Time frame: From enrollment to day 1 (D1) post-MRgHIFU
Linear acceleration of tremor
Time frame: From enrollment to day 1 (D1) post-MRgHIFU
Angular velocity of tremor
Time frame: From enrollment to day 1 (D1) post-MRgHIFU
Incidence of Device-Emergent (Serious) Adverse Events [Safety]
Time frame: From enrollment to day 1 (D1) post-stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including demographic data, clinical characteristics, and quantitative tremor assessment data, will be shared. Data will be available upon reasonable request to the corresponding author after publication of the primary results, in accordance with ethical approval and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Lüscher, Full Professor principal investigator
Department of Basic Neuroscience, University of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial temporal interference stimulation and Tremor monitoring through Inertial Measurement Units (IMUs) in people with Essential Tremor, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 inclusion and 8 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 1 May 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 Switzerland. 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 Christian Lüscher, Full Professor (+41 22 379 54 44, christian.luscher@unige.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor amplitude (time frame: From enrollment to day 1 (D1) after MRgHIFU). 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 1 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.