Temporal Interference Brain Stimulation Phase I Clinical Trial

Taipei Veterans General Hospital

Status and phase: Enrolling; Phase 1

Conditions: Temporal Interference Stimulation; Crossover Study; Health Adults; Safety and Effectiveness

Treatments: Device: Temporal Interference Stimulation - Sham first; Device: Temporal Interference Stimulation - Treatment first

Study type: Interventional

Funder types: Other

Identifiers

NCT07179848

2024-04-001A

NSTC 112-2321-B-A49-013 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults from the community
• Age between 20 and 65 years old
• No diagnosis of severe psychiatric disorders
• No family history of psychiatric diseases

Exclusion criteria

• 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)
• History of substance abuse
• Diagnosis of cancer or malignant tumors
• Chronic kidney failure or undergoing hemodialysis
• Pregnant or breastfeeding
• Severe arrythmia, presence of pacemaker, or metal implants in the brain
• Claustrophobia
• History or family history of seizure
• History of syncope
• Organic brian disease, brain trauma, or history of neurosurgery
• Received electroconvulsive therapy or repetitive transcranial magnetic stimulation within the past month
• Skin disoreders (e.g., dermatitis, psoriasis, eczema)
• Currently participating in other clinical interventional trials
• Presence of any metal implants or devices affected by electromagnetic fields

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 8 patient groups

Hippocampus - Treatment first

Experimental group

Treatment:

Device: Temporal Interference Stimulation - Treatment first

Hippocampus - Sham first

Sham Comparator group

Treatment:

Device: Temporal Interference Stimulation - Sham first

Insula - Treatment first

Experimental group

Treatment:

Device: Temporal Interference Stimulation - Treatment first

Insula - Sham first

Sham Comparator group

Treatment:

Device: Temporal Interference Stimulation - Sham first

Anterior cingulate cortex - Treatment first

Experimental group

Treatment:

Device: Temporal Interference Stimulation - Treatment first

Anterior cingulate cortex - Sham first

Sham Comparator group

Treatment:

Device: Temporal Interference Stimulation - Sham first

Inferior frontal cortex - Treatment first

Experimental group

Treatment:

Device: Temporal Interference Stimulation - Treatment first

Inferior frontal cortex - Sham first

Sham Comparator group

Treatment:

Device: Temporal Interference Stimulation - Sham first