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.
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
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;
Parallel
Transcranial temporal interference stimulation
DeviceWe 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 interventionEssential 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).
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.
Tremor peak frequency
Peak (dominant) frequency of the tremor in Hz
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
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
Power of the tremor
Power band spectrum, measured in dB, derived from the three-dimensional data of the IMU
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University Hospital, Geneva
Lead sponsor
University of Geneva, Switzerland
Collaborator
Wyss Center for Bio and Neuroengineering
Collaborator
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