Safety and Feasibility of Temporal Interference Brain Stimulation for Treatment in Psychiatric Disorders
NCT ID: NCT07179848
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2025-02-26
2026-10-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Hippocampus - Treatment first
Temporal Interference Stimulation - Treatment first
Receive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation
Hippocampus - Sham first
Temporal Interference Stimulation - Sham first
Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation
Insula - Treatment first
Temporal Interference Stimulation - Treatment first
Receive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation
Insula - Sham first
Temporal Interference Stimulation - Sham first
Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation
Anterior cingulate cortex - Treatment first
Temporal Interference Stimulation - Treatment first
Receive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation
Anterior cingulate cortex - Sham first
Temporal Interference Stimulation - Sham first
Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation
Inferior frontal cortex - Treatment first
Temporal Interference Stimulation - Treatment first
Receive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation
Inferior frontal cortex - Sham first
Temporal Interference Stimulation - Sham first
Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation
Interventions
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Temporal Interference Stimulation - Treatment first
Receive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation
Temporal Interference Stimulation - Sham first
Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation
Eligibility Criteria
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Inclusion Criteria
* Age between 20 and 65 years old
* No diagnosis of severe psychiatric disorders
* No family history of psychiatric diseases
Exclusion Criteria
* 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, brian trauma, or history of neurosurgery
* Received electroconvulsive therapy or repetitive transcranial magnetic stimulation within the past month
* Skin disorders (e.g., dermatitis, psoriasis, eczema)
* Currently participating in other clinical interventional trials
* Presence of any metal implants or devices affected by electromagnetic fields
20 Years
65 Years
ALL
Yes
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Locations
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Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NSTC 112-2321-B-A49-013
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-04-001A
Identifier Type: -
Identifier Source: org_study_id
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