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| ID | Type | Description | Link |
|---|---|---|---|
| NSTC 112-2321-B-A49-013 | Other Grant/Funding Number | National Science and Technology Council (NSTC) |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hippocampus - Treatment first | Experimental |
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| Hippocampus - Sham first | Sham Comparator |
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| Insula - Treatment first | Experimental |
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| Insula - Sham first | Sham Comparator |
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| Anterior cingulate cortex - Treatment first | Experimental |
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| Anterior cingulate cortex - Sham first | Sham Comparator |
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| Inferior frontal cortex - Treatment first | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference Stimulation - Treatment first | Device | Receive treatment stimulation for 5 consecutive days, followed by a 2-days washout period, then complete the remaining 5 days of sham stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albert Chih-Chieh Yang, MD, PhD | Contact | +886-2-2826-7000 | accyang@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Recruiting | Taipei | 112 | Taiwan |
Due to the limited sample size, the risk of participant re-identification may be higher.
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| Inferior frontal cortex - Sham first | Sham Comparator |
|
| Temporal Interference Stimulation - Sham first | Device | Receive sham stimulation for 5 consecutive days, followed by a 2-days washout period, then undergo 5 days of treatment 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. |
| 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. | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation |
| 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. | Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session |