Safety and Feasibility of Temporal Interference Brain Stimulation for Treatment in Psychiatric Disorders

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

The goal of this clinical trial is to validate if temporal interference brain stimulation (TIBS) is safe in healthy volunteers aged 20 to 65. The main questions it aims to answer are:

* Is it safe to apply TIBS intervention to the left hippocampus in healthy participants? * Is it safe to apply TIBS intervention to the left insula in healthy participants? * Is it safe to apply TIBS intervention to the left anterior cingulate cortex in healthy participants? * Is it safe to apply TIBS intervention to the right inferior frontal cortex in healthy participants?

Participants will:

* Be Randomly allocated to either sham-first group or treat first-group, stratified by stimulated brain region, following a crossover-controlled experimental design * Complete baseline cognitive evaluations and mental status assessments, and undergo a baseline MRI scan on the same day * Receive stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of stimulation. * Complete post-intervention cognitive evaluations and mental status assessments, and undergo a post-intervention MRI scan on the same day

Eligibility criteria

Qualifiers

Healthy adults from the community

Age between 20 and 65 years old

No diagnosis of severe psychiatric disorders

No family history of psychiatric diseases

Disqualifiers

Age below 20 years old or above 65 years old

Currently prescribed any medication

Diagnosis of psychiatric disorders (e.g., Major Depressive Disorder, Bipolar Disorder, Schizophrenia)

Diagnosis of neurological disorders (e.g., Dementia, Stroke, Parkinson's disease)

Trial design

Treatments tested in this trial

  • Temporal Interference Stimulation - Treatment first
  • Temporal Interference Stimulation - Sham first

Treatment groups

80 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.