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

Phase 1RecruitingNCT07179848

Taipei Veterans General Hospital, Taiwan80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Health Adults Temporal Interference Stimulation

Interventions

Temporal Interference Stimulation - Treatment firstDEVICE

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 firstDEVICE

Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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, 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

Outcomes

Primary Outcomes

Changes in NRS related to intervention

Numeric rating scale (NRS) will be used to evaluate the side effects, pain intensity, and other adverse events potentially related to the intervention, at baseline, during stimulation, immediately after each session, and at follow-up.

Time frame: Baseline (before each stimulation session), midpoint during each session, immediately after each stimulation for 10 sessions (approximately 2 weeks), and 1 month after completion of all sessions.

Changes in VAS related to intervention

Visual analog scale (VAS) will be used to evaluate the side effects, pain intensity, and other adverse events potentially related to the intervention, at baseline, during stimulation, immediately after each session, and at follow-up.

Changes in MMSE from baseline to post-intervention

Mini-Mental State Examination (MMSE) will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention. Cognitive function will be considered normal if the MMSE score is greater than 24.

Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session

Changes in BAI from baseline to post-intervention

Beck Anxiety Inventory (BAI) will be administered to evaluate the mental status approximately 1 week before the first intervention and 1 week after the last intervention. Mental status will be considered stable if both BAI and BDI are less than 13.

Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation

Changes in BDI from baseline to post-intervention

Beck Depression Inventory (BDI) will be administered to evaluate the mental status approximately 1 week before the first intervention and 1 week after the last intervention. Mental status will be considered stable if both BAI and BDI are less than 13.

Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation

Changes in MRI from baseline to post-intervention

T1-weighted magnetic resonance imaging (T1-weighted MRI) and resting-state functional magnetic resonance imaging (resting-state fMRI) will be acquired to evaluate structural and functional brain alterations potentially related to the intervention. Imaging will be performed approximately 1 week before the first intervention and 1 week after the last intervention.

Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation

Secondary Outcomes

Changes in WCST score from baseline to post-intervention

Wisconsin Card Sorting Test (WCST) will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention.

Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session

Changes in verbal fluency test from baseline to post-intervention

Verbal fluency test will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention.

Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts