Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor

Sponsor
University Hospital, Geneva
Study ID
NCT07531238
Status
Not Yet Recruiting

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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial temporal interference stimulation — DEVICE
    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 Details

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.

Key Dates

First listed
Apr 15, 2026
Start date
May 26, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Experimental arm: tTIS stimulation protocol
    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.
  • Other: Control arm: Tremor Monitoring
    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.

Primary Outcome Measure

Tremor amplitude [ Time Frame: From enrollment to day 1 (D1) after MRgHIFU ]

Central Contacts

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