Safety and Feasibility of Temporal Interference Brain Stimulation for Treatment in Psychiatric Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Temporal Interference Stimulation - Treatment first, Temporal Interference Stimulation - Sham first.
- Who it may be relevant to
- Registry conditions: Health Adults, Temporal Interference Stimulation, Safety and Effectiveness, Crossover Study. Basic parameters: 20 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase I Clinical Trial of a New Non-invasive Deep Brain Stimulation Technique
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
Interventions
- Device 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 - Device 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
Primary outcome measures
- Changes in NRS related to intervention [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 [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 MMSE from baseline to post-intervention [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 [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 [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 [Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation]
Secondary outcome measures (2)
- Changes in WCST score from baseline to post-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 [Time frame: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT07179848 · 2024-04-001A · NSTC 112-2321-B-A49-013