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

Официальное название

Phase I Clinical Trial of a New Non-invasive Deep Brain Stimulation Technique

Обзор

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

Вмешательства

• Устройство 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
• Устройство 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

Первичные конечные точки

• Changes in NRS related to intervention [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation]

Вторичные конечные точки (2)

• Changes in WCST score from baseline to post-intervention [Срок оценки: 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 [Срок оценки: Approximately 1 week prior to the first stimulation session and approximately 1 week following the last stimulation session]

Критерии участия

Критерии включения

• Healthy adults from the community
• Age between 20 and 65 years old
• No diagnosis of severe psychiatric disorders
• No family history of psychiatric diseases

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT07179848 · 2024-04-001A · NSTC 112-2321-B-A49-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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