Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor
TremorTIS
1 other identifier
interventional
6
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2026
CompletedStudy Start
First participant enrolled
May 26, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
Study Completion
Last participant's last visit for all outcomes
May 1, 2027
May 1, 2026
April 1, 2026
11 months
December 17, 2025
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From enrollment to day 1 (D1) after MRgHIFU
Secondary Outcomes (8)
Tremor peak frequency
From enrollment to day 1 (D1) post-MRgHIFU
Frequency Width Half Maximum (FWHM)
From enrollment to day 1 (D1) post-MRgHIFU
Tremor Stability Index (TSI)
From enrollment to day 1 (D1) post-MRgHIFU
Power of the tremor
From enrollment to day 1 (D1) post-MRgHIFU
Half-Width Power (HWP)
From enrollment to day 1 (D1) post-MRgHIFU
- +3 more secondary outcomes
Study Arms (2)
Experimental arm: tTIS stimulation protocol
EXPERIMENTALIn 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
OTHERIn this arm, essential tremor patients who are candidates for MRgHIFU will undergo only tremor monitoring using Inertial Measurement Units (IMUs) before and after MRgHIFU.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Genevalead
- University of Geneva, Switzerlandcollaborator
- Wyss Center for Bio and Neuroengineeringcollaborator
Study Sites (1)
University of Geneva (UNIGE)
Geneva, 1205, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Lüscher, Full Professor
Department of Basic Neuroscience, University of Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Movement Disorders unit, Neurology Department
Study Record Dates
First Submitted
December 17, 2025
First Posted
April 15, 2026
Study Start (Estimated)
May 26, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After publication of the primary results, upon reasonable request.
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.