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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Temporal Interference Stimulation - Treatment first
DeviceReceive 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
DeviceReceive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment stimulation
Treatment groups
80 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Hippocampus - Treatment firstExperimental treatment 1 intervention
Group B: Hippocampus - Sham firstSham comparator 1 intervention
Group C: Insula - Treatment firstExperimental treatment 1 intervention
Group D: Insula - Sham firstSham comparator 1 intervention
Group E: Anterior cingulate cortex - Treatment firstExperimental treatment 1 intervention
Group F: Anterior cingulate cortex - Sham firstSham comparator 1 intervention
Group G: Inferior frontal cortex - Treatment firstExperimental treatment 1 intervention
Group H: Inferior frontal cortex - Sham firstSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.
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.3
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 session4
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 stimulationSecondary outcomes
1
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 session2
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 sessionSponsors and contacts
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Source ClinicalTrials.gov