Temporal Interference Transcranial Alternating Current Stimulation for Major Depressive Disorder and Generalized Anxiety Disorder
A Double-Blind, Randomized, Sham-Controlled Clinical Trial of Temporal Interference Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder and Generalized Anxiety Disorder
This multi-center, double-blind study, randomized controlled trial aims to evaluate the efficacy and safety of Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) in patients with major depressive disorder (MDD) and generalized anxiety disorder (GAD).
All participants will be enrolled as two independent cohorts and randomized separately within each diagnostic group. Participants with major depressive disorder will be randomized to receive high-frequency TI-tACS(130 Hz), low-frequency TI-tACS(2Hz), or sham stimulation targeting the right amygdala. Participants with generalized anxiety disorder will be randomized to receive high-frequency TI-tACS(80Hz), low-frequency TI-tACS(5Hz), or sham stimulation targeting the right amygdala.
The intervention consists of 20 stimulation sessions administered over 2 weeks (twice a day for 5 consecutive days, followed by a 2-day break, and another 5 consecutive days). Clinical assessments will be conducted at baseline, during treatment, and at multiple follow-up time points up to 6 months.
The primary outcome for the MDD cohort is the change from baseline in the Hamilton Depression Rating Scale (HAMD-17) at week 2. The primary outcome for the GAD cohort is the change from baseline in the Hamilton Anxiety Rating Scale (HAMA) at week 2. Secondary outcomes include changes in clinical symptoms, cognitive function, and safety profiles in both the MDD and GAD cohorts.
Přehled studie
Postavení
Detailní popis
Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are highly prevalent psychiatric disorders associated with substantial disability and impaired quality of life. Neuroimaging studies have demonstrated abnormalities in distributed cortical-subcortical circuits, particularly involving the amygdala, which plays a central role in emotional processing and symptom regulation. Although several neuromodulation techniques have shown therapeutic potential, currently available approaches have limited ability to selectively modulate deep brain structures without invasive procedures.
Temporal interference transcranial alternating current stimulation (TI-tACS) is a novel non-invasive neuromodulation technique that delivers two high-frequency alternating currents with slightly different frequencies to generate a low-frequency envelope within deep brain regions. This approach enables selective modulation of deep neural structures, such as the amygdala, while minimizing stimulation of the overlying cortex.
This is a multicenter, randomized, triple-blind, sham-controlled clinical trial designed to evaluate the efficacy, safety, and neurobiological mechanisms of TI-tACS in participants with MDD or GAD. Participants with either disorders will be enrolled as independent cohorts and randomized separately within each diagnostic group to receive active or sham TI-tACS according to the study protocol.
Approximately 192 participants (102 with MDD and 90 with GAD) will be recruited. Following written informed consent, participants will undergo baseline assessments and subsequent study evaluations according to the protocol. Study assessments include clinical evaluations, neurocognitive testing, electroencephalography (EEG), magnetic resonance imaging (MRI), and biological sample collection. TI-tACS treatment consists of 20 stimulation sessions administered over two weeks (two sessions per day for five consecutive days, followed by a two-day break, and another five consecutive treatment days).
Participants will also complete scheduled post-treatment follow-up assessments to evaluate the persistence of treatment effects and the long-term safety of TI-tACS.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Yumeng Ju( Associate Researcher), PhD
- Telefonní číslo: 86+18100731091
- E-mail: yumeng.ju@csu.edu.cn
Studijní záloha kontaktů
- Jméno: Lingsi Zeng, PhD Candidate
- E-mail: zenglsi@163.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age between 18 and 55 years (inclusive), any gender;
- Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features;
- For MDD participants: HAMD-17 score ≥14; inadequate response to stable, regular antidepressant medication for at least 1 month at an adequate dose;
- For GAD participants: HAMA score ≥14; stable, regular medication for at least 2 months;
- Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments;
- Voluntary participation with signed informed consent; ability to comply with study visits, treatment schedules, laboratory tests, and other study procedures.
Exclusion Criteria:
- History of psychiatric disorders other than MDD or GAD;
- Pregnancy or lactation;
- Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma);
- History of significant head injury or coma
- Receipt of physical therapies such as electroconvulsive therapy or rTMS within the past six months before enrollment
- Suspected or confirmed history of alcohol or substance dependence;
- Current severe suicidal ideation or recent suicide attempt;
- Current participation in another clinical trial or recent use of prohibited psychotropic medications;
- Positive urine drug screening or abnormal thyroid function tests;
- Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG);
- Inability to provide fully informed consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: MDD - High-frequency TI-tACS
Participants in the MDD - High-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (130Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents. In the MDD cohort, low-frequency stimulation will be delivered at 2 Hz and high-frequency stimulation at 130 Hz. In the GAD cohort, low-frequency stimulation will be delivered at 5 Hz and high-frequency stimulation at 80 Hz.
Ostatní jména:
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Experimentální: MDD - Low-frequency TI-tACS
Participants in the MDD - Low-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (2 Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents. In the MDD cohort, low-frequency stimulation will be delivered at 2 Hz and high-frequency stimulation at 130 Hz. In the GAD cohort, low-frequency stimulation will be delivered at 5 Hz and high-frequency stimulation at 80 Hz.
Ostatní jména:
|
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Falešný srovnávač: MDD - Sham TI-tACS
Participants in the MDD - Sham TI-tACS group receive 20-minute sham stimulation of the same device twice a day for 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
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Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
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Experimentální: GAD - High-frequency TI-tACS
Participants in the GAD - High-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (80Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents. In the MDD cohort, low-frequency stimulation will be delivered at 2 Hz and high-frequency stimulation at 130 Hz. In the GAD cohort, low-frequency stimulation will be delivered at 5 Hz and high-frequency stimulation at 80 Hz.
Ostatní jména:
|
|
Experimentální: GAD - Low-frequency TI-tACS
Participants in the GAD - Low-frequency TI-tACS group receive 20-minute temporal interference transcranial alternating current stimulation (5Hz) twice a day, delivered via two pairs of transcranial electrodes, targeting the right amygdala.
The stimulation is administered in 2 weeks, consisting of 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS) is a non-invasive neuromodulation technique that generates a low-frequency envelope field in deep brain regions, particularly the right amygdala, through the interaction of two high-frequency currents. In the MDD cohort, low-frequency stimulation will be delivered at 2 Hz and high-frequency stimulation at 130 Hz. In the GAD cohort, low-frequency stimulation will be delivered at 5 Hz and high-frequency stimulation at 80 Hz.
Ostatní jména:
|
|
Falešný srovnávač: GAD - Sham TI-tACS
Participants in the GAD - Sham TI-tACS group receive 20-minute sham stimulation of the same device twice a day for 5 consecutive treatment days, followed by a 2-day break, and then another 5 consecutive treatment days.
|
Sham Temporal Interference transcranial Alternating Current Stimulation will mimic the sensory experience of active stimulation without delivering effective current.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in the Hamilton Depression Rating Scale(HAMD-17) scores at week 2 for MDD participants. Change from baseline in the Hamilton Anxiety Rating Scale(HAMA) scores at week 2 for GAD participants.
Časové okno: 2 weeks(from baseline)
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-administered instrument used to assess the severity of depressive symptoms. The scale consists of 17 items with a total score ranging from 0 to 52. Higher scores indicate more severe depressive symptoms. The outcome for MDD participants will be calculated as the change in HAMD-17 score from baseline to Week 2. The Hamilton Anxiety Rating Scale (HAMA) is a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. The outcome for GAD participants will be calculated as the change in HAMA total score from baseline to Week 2. |
2 weeks(from baseline)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score for Participants With Major Depressive Disorder
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered instrument used to assess the severity of depressive symptoms and sensitivity to treatment-related changes.
The scale consists of 10 items with a total score ranging from 0 to 60. Higher scores indicate more severe depressive symptoms.
|
Baseline to month 2 follow-up(post treatment)
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Adverse Events Related to treatment
Časové okno: Baseline to month 2 follow-up(post treatment)
|
Incidence, type, and severity of adverse events related to the transcranial temporal interference stimulation, assessed using a standardized Neuromodulation Adverse Effects Questionnaire.
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Baseline to month 2 follow-up(post treatment)
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Change in Intolerance of Uncertainty Scale (IUS) Score in Participants With Generalized Anxiety Disorder
Časové okno: Baseline to month 2 follow-up(post treatment)
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The Intolerance of Uncertainty Scale (IUS-12) is a 12-item self-report questionnaire used to assess an individual's tendency to perceive uncertain situations as stressful and unacceptable.
Total scores range from 12 to 60, with higher scores indicating greater intolerance of uncertainty.
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Baseline to month 2 follow-up(post treatment)
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Change in Penn State Worry Questionnaire (PSWQ) Score in Participants With Generalized Anxiety Disorder
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The Penn State Worry Questionnaire (PSWQ) is a 16-item self-report questionnaire used to assess the tendency to engage in excessive, pervasive, and uncontrollable worry.
Total scores range from 16 to 80, with higher scores indicating greater pathological worry.
|
Baseline to month 2 follow-up(post treatment)
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Change in Patient Health Questionnaire-9 (PHQ-9)
Časové okno: Baseline to month 2 follow-up(post treatment)
|
A 9-item self-report questionnaire used to assess depressive symptom severity.
Total scores range from 0 to 27, with higher scores indicating greater depression severity.
|
Baseline to month 2 follow-up(post treatment)
|
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Change in the Hamilton Anxiety Rating Scale (HAMA) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The Hamilton Depression Rating Scale-17 (HAMD-17) is a 17-item clinician-administered scale used to assess the severity of depressive symptoms.
The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.
|
Baseline to month 2 follow-up(post treatment)
|
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Change in Young Mania Rating Scale (YMRS) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The Young Mania Rating Scale (YMRS) is an 11-item clinician-administered instrument used to assess the severity of manic symptoms and to monitor treatment-emergent mania or hypomania.
Total scores range from 0 to 60, with higher scores indicating more severe manic symptoms.
|
Baseline to month 2 follow-up(post treatment)
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire used to assess subjective sleep quality and sleep disturbances over the previous month.
The questionnaire generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
|
Baseline to month 2 follow-up(post treatment)
|
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Change in Beck Scale for Suicide Ideation (BSI) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The Beck Scale for Suicide Ideation (BSI) is a 19-item clinician-administered instrument used to assess the severity of suicidal thoughts, attitudes, and intentions.
Total scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.
|
Baseline to month 2 follow-up(post treatment)
|
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hange in 10-item Connor-Davidson Resilience Scale (CD-RISC-10) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) is a 10-item self-report questionnaire used to assess psychological resilience and the ability to cope with adversity.
Total scores range from 0 to 40, with higher scores indicating greater psychological resilience.
|
Baseline to month 2 follow-up(post treatment)
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Change in Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The Chinese Version of the Cognitive Emotion Regulation Questionnaire (CERQ-C) is a 36-item self-report questionnaire used to assess cognitive emotion regulation strategies in response to stressful or negative life events.
Total scores range from 36 to 180, with higher scores indicating greater use of cognitive emotion regulation strategies.
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Baseline to month 2 follow-up(post treatment)
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Change in State Anxiety Inventory (S-AI) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
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The State Anxiety Inventory (S-AI) is a 20-item self-report questionnaire used to assess transient anxiety experienced at the time of assessment.
Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
|
Baseline to month 2 follow-up(post treatment)
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Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
A 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms.
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
|
Baseline to month 2 follow-up(post treatment)
|
|
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a 17-item clinician-administered instrument used to assess the severity of depressive symptoms.
Total scores range from 0 to 52, with higher scores indicating more severe depressive symptoms.
|
Baseline to month 2 follow-up(post treatment)
|
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Change in Sheehan Disability Scale (SDS) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
|
he Sheehan Disability Scale (SDS) is a 3-item self-report questionnaire used to assess functional impairment in work/school, social life, and family life/home responsibilities.
Total scores range from 0 to 30, with higher scores indicating greater functional impairment.
|
Baseline to month 2 follow-up(post treatment)
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Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
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The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self-report questionnaire used to assess anhedonia, or the ability to experience pleasure.
Total scores range from 14 to 56, with higher scores indicating greater anhedonia (reduced ability to experience pleasure).
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Baseline to month 2 follow-up(post treatment)
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Change in Ruminative Responses Scale (RRS) Score
Časové okno: Baseline to month 2 follow-up(post treatment)
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The Ruminative Responses Scale (RRS) is a 22-item self-report questionnaire used to assess the tendency to engage in repetitive negative thinking in response to depressed mood or distress.
Total scores range from 22 to 88, with higher scores indicating greater rumination.
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Baseline to month 2 follow-up(post treatment)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Yan Zhang, PhD, Second Xiangya Hospital of Central South University
- Vrchní vyšetřovatel: Yumeng Ju, PhD, Second Xiangya Hospital of Central South University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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