How electrical brain stimulation affects shaking in essential tremor

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with essential tremor who are planned for MRgHIFU thalamotomy, an ultrasound brain procedure. Some will also get tTIS, a non-invasive brain stimulation.

Age

18 years and older

Sex

All sexes

Disease stage

Essential tremor diagnosed by the Movement Disorders Society criteria. Must be a candidate for MRgHIFU thalamotomy.

Main reasons for not taking part

• Unable to give informed consent
• Severe sensory, thinking or muscle and joint problems that prevent following instructions or doing the tasks
• For the stimulation group: severe mental illness (such as major depression, severe dementia, psychosis) or unstable serious body-wide disease
• For the stimulation group: electronic or metal medical implants or devices
• For the stimulation group: past seizures, or unable to follow study procedures

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Experimental arm: tTIS stimulation protocolTreatment being tested

  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.

  Treatment: Transcranial temporal interference stimulation and Tremor monitoring through Inertial Measurement Units (IMUs)

• Control arm: Tremor MonitoringOther group

  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.

  Treatment: Tremor monitoring through Inertial Measurement Units (IMUs)