Transcranial Temporal Interference Stimulation (tTIS) To Modulate Essential Tremor
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Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University Hospital, Geneva
- Azonosító
- NCT07531238
- A regiszteradat frissítve
- 2026. május 1.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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); Contraindications for non-invasive brain stimulation:; Electronic or ferromagnetic medical implants or devices; History of seizures; Unable to provide informed consent; Inability to follow or non-compliance with the procedures of the study.