Crossover Study, Health Adults, Safety and Effectiveness, Temporal Interference Stimulation
Conditions
Keywords
Hippocampus, Temporal Interference Stimulation, Insula, Anterior Cingulate Cortex, Inferior Frontal Cortex
Brief summary
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
DEVICETemporal 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
DEVICETemporal 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
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NRS related to intervention | 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. | 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. |
| Changes in VAS related to intervention | 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. | 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 | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session | 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. |
| Changes in BAI from baseline to post-intervention | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation | 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. |
| Changes in BDI from baseline to post-intervention | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation | 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. |
| Changes in MRI from baseline to post-intervention | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in WCST score from baseline to post-intervention | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session | 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. |
| Changes in verbal fluency test from baseline to post-intervention | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session | Verbal fluency test will be administered to evaluate cognitive function approximately 1 week before the first intervention and 1 week after the last intervention. |
Countries
Taiwan
Contacts
CONTACTAlbert Chih-Chieh Yang, MD, PhD
Outcome results
None listed