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Studies

Interventional Not yet recruiting

NCT07531238 on ClinicalTrials.gov

Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor

Official title: Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor: A Single-Center, Proof-of-Concept Study (TremorTIS (Pilot))

  • Sponsor: Geneva General Hospital
  • Collaborators: University of Geneva, Switzerland, Wyss Center for Bio and Neuroengineering
  • Enrollment: 6 (Estimated)
  • Study start: 2026-05-26 (Estimated)
  • Primary completion: 2027-04-30 (Estimated)
  • Study completion: 2027-05-01 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • Masking: Double (Participant, Investigator)
  • PrimaryPurpose: Other

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.

Conditions

  • Essential Tremor

Intervention / Treatment

  • Device: Transcranial temporal interference stimulation
  • Other: Tremor monitoring through Inertial Measurement Units (IMUs)

Primary Outcome Measures

  • Tremor amplitude (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.

Countries

Switzerland

Locations and Investigators

Study Officials