Efficacy and Safety of Transcranial Temporal Interference Stimulation for Depression
27 maja 2026 zaktualizowane przez: Yonggui Yuan
The goal of this clinical trial is to learn whether transcranial temporal interference stimulation (tTIS) can help treat major depressive disorder (MDD) in adults. The study will also learn about the safety of tTIS and explore how it may affect brain structure and brain function.
The main questions it aims to answer are whether active tTIS lowers depression symptom scores more than sham stimulation after treatment, and what medical problems or side effects participants have during or after tTIS.
Researchers will compare active tTIS targeting the left anterior limb of the internal capsule, active tTIS targeting the left subgenual anterior cingulate cortex, and sham stimulation. Sham stimulation is designed to feel similar to real stimulation but does not provide the same active treatment.
Participants with MDD will be randomly assigned to one of the three groups. They will receive two 20-minute treatment sessions each day for 5 days. They will complete depression, anxiety, pleasure, psychosomatic symptom, and safety assessments before treatment, after treatment, and during follow-up. They will also have brain magnetic resonance imaging scans before and after treatment.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Szczegółowy opis
Major depressive disorder (MDD) is a common and disabling mental disorder. Although medication, psychotherapy, and established brain stimulation methods can help many people with MDD, some participants still have insufficient improvement. Transcranial temporal interference stimulation (tTIS) is a non-invasive brain stimulation technique that may allow modulation of deeper brain regions or pathways. This study is designed to evaluate whether tTIS can improve depressive symptoms in adults with MDD, assess its safety, and explore potential neuroimaging mechanisms.
This is a single-center, randomized, double-blind, sham-controlled clinical trial conducted at Zhongda Hospital, Southeast University. Eligible participants with MDD will be randomly assigned in a 1:1:1 ratio to one of three groups: active tTIS targeting the left anterior limb of the internal capsule (ALIC), active tTIS targeting the left subgenual anterior cingulate cortex (sgACC), or sham tTIS. The sham stimulation will be designed to provide sensory feedback similar to active stimulation while maintaining blinding.
Participants with MDD will receive 10 treatment sessions over 5 consecutive days, with two 20-minute sessions each day. Clinical symptoms and safety will be assessed at baseline, after treatment, and during follow-up. The main clinical outcome is the change in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline to after treatment. Secondary outcomes include follow-up changes in depressive symptoms, response and remission rates, anxiety symptoms, anhedonia, psychosomatic symptoms, side effects, and adverse events.
Multimodal 5.0T brain magnetic resonance imaging (MRI) will be collected from participants with MDD before and after treatment. MRI measures will include structural imaging, resting-state functional imaging, and diffusion imaging. These data will be used to explore changes in brain structure, functional connectivity, and diffusion-related measures after tTIS, and to identify potential imaging biomarkers related to treatment response.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Yue Zhou, MD Candidate
- Numer telefonu: +86 15651003002
- E-mail: 2725106172@qq.com
Kopia zapasowa kontaktu do badania
- Nazwa: Yubo Zhang, MD Candidate
- Numer telefonu: +86 18651617808
- E-mail: 1301053461@qq.com
Lokalizacje studiów
-
-
Jiangsu
-
Nanjing, Jiangsu, Chiny, 210009
- Zhongda Hospital Southeast University
-
Kontakt:
- Yue Zhou, MD Candidate
- Numer telefonu: +86 15651003002
- E-mail: 2725106172@qq.com
-
Kontakt:
- Yubo Zhang, MD Candidate
- Numer telefonu: +86 1865161780
- E-mail: 1301053461@qq.com
-
Główny śledczy:
- Yonggui Yuan, PhD
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), by two independent psychiatrists
- 24-item Hamilton Depression Rating Scale (HAMD-24) total score greater than 20 at baseline
- Aged 18 to 65 years
- Right-handed
- Able to understand the study procedures and willing to provide written informed consent
Exclusion Criteria:
- History of epilepsy, brain tumor, or brain trauma
- Receipt of transcranial magnetic stimulation, transcranial electrical stimulation, or electroconvulsive therapy within the past 3 months
- Presence of metal implants or other contraindications to transcranial electrical stimulation or magnetic resonance imaging
- Acute or severe suicidal ideation
- Any other condition judged by the investigators to make participation unsuitable for this study
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Active tTIS Targeting Left ALIC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC).
Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions.
|
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left anterior limb of the internal capsule (ALIC).
The stimulation target will be individualized based on each participant's magnetic resonance imaging data.
The difference frequency will be 130 Hz.
Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Inne nazwy:
|
|
Aktywny komparator: Active tTIS Targeting Left sgACC
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC).
Treatment will be delivered twice daily for 5 consecutive days, with each session lasting 20 minutes and a 30-minute interval between sessions.
|
Participants in this arm will receive active transcranial temporal interference stimulation (tTIS) targeting the left subgenual anterior cingulate cortex (sgACC).
The stimulation target will be individualized based on each participant's magnetic resonance imaging data.
The difference frequency will be 130 Hz.
Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Inne nazwy:
|
|
Pozorny komparator: Sham tTIS
Participants in this arm will receive sham transcranial temporal interference stimulation (tTIS).
Sham stimulation will be delivered using the same type of device and will provide sensory feedback similar to active stimulation, but it will not provide the same active treatment dose.
Treatment sessions will follow the same schedule as the active stimulation arms.
|
Participants in this arm will receive sham transcranial temporal interference stimulation (tTIS) using the same type of device as active stimulation.
Sham stimulation will provide sensory feedback similar to active stimulation to help maintain masking, but it will not deliver the same active treatment dose.
Each session will last 20 minutes, twice daily for 5 consecutive days, with a 30-minute interval between sessions.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 1
Ramy czasowe: Baseline and Week 1
|
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess the severity of depressive symptoms.
The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms.
The primary outcome is the change in HAMD-24 total score from baseline to Week 1.
|
Baseline and Week 1
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 2
Ramy czasowe: Baseline and Week 2
|
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms.
The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms.
This outcome measures the change in HAMD-24 total score from baseline to Week 2.
|
Baseline and Week 2
|
|
Change in 24-item Hamilton Depression Rating Scale (HAMD-24) Total Score From Baseline to Week 6
Ramy czasowe: Baseline and Week 6
|
The 24-item Hamilton Depression Rating Scale (HAMD-24) will be used to assess depressive symptoms.
The total score ranges from 0 to 76, with higher scores indicating more severe depressive symptoms.
This outcome measures the change in HAMD-24 total score from baseline to Week 6.
|
Baseline and Week 6
|
|
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
Ramy czasowe: Week 1
|
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower.
This outcome measures the proportion of participants who meet the remission criterion at Week 1.
|
Week 1
|
|
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
Ramy czasowe: Week 2
|
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower.
This outcome measures the proportion of participants who meet the remission criterion at Week 2.
|
Week 2
|
|
Remission Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
Ramy czasowe: Week 6
|
Remission is defined as a 24-item Hamilton Depression Rating Scale (HAMD-24) total score of 9 or lower.
This outcome measures the proportion of participants who meet the remission criterion at Week 6.
|
Week 6
|
|
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 1
Ramy czasowe: Baseline and Week 1
|
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline.
This outcome measures the proportion of participants who meet the response criterion at Week 1.
|
Baseline and Week 1
|
|
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 2
Ramy czasowe: Baseline and Week 2
|
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline.
This outcome measures the proportion of participants who meet the response criterion at Week 2.
|
Baseline and Week 2
|
|
Response Rate Based on the 24-item Hamilton Depression Rating Scale (HAMD-24) at Week 6
Ramy czasowe: Baseline and Week 6
|
Response is defined as a reduction of at least 50% in the 24-item Hamilton Depression Rating Scale (HAMD-24) total score from baseline.
This outcome measures the proportion of participants who meet the response criterion at Week 6.
|
Baseline and Week 6
|
|
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 1
Ramy czasowe: Baseline and Week 1
|
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms.
The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
This outcome measures the change in HAMA total score from baseline to Week 1.
|
Baseline and Week 1
|
|
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 2
Ramy czasowe: Baseline and Week 2
|
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms.
The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
This outcome measures the change in HAMA total score from baseline to Week 2.
|
Baseline and Week 2
|
|
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Week 6
Ramy czasowe: Baseline and Week 6
|
The Hamilton Anxiety Rating Scale (HAMA) will be used to assess anxiety symptoms.
The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.
This outcome measures the change in HAMA total score from baseline to Week 6.
|
Baseline and Week 6
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 1
Ramy czasowe: Baseline and Week 1
|
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia.
The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia.
This outcome measures the change in SHAPS total score from baseline to Week 1.
|
Baseline and Week 1
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 2
Ramy czasowe: Baseline and Week 2
|
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia.
The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia.
This outcome measures the change in SHAPS total score from baseline to Week 2.
|
Baseline and Week 2
|
|
Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score From Baseline to Week 6
Ramy czasowe: Baseline and Week 6
|
The Snaith-Hamilton Pleasure Scale (SHAPS) will be used to assess anhedonia.
The total score ranges from 0 to 14, with higher scores indicating more severe anhedonia.
This outcome measures the change in SHAPS total score from baseline to Week 6.
|
Baseline and Week 6
|
|
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 1
Ramy czasowe: Baseline and Week 1
|
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms.
Higher scores indicate more severe psychosomatic symptoms.
This outcome measures the change in PSSS total score from baseline to Week 1.
|
Baseline and Week 1
|
|
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 2
Ramy czasowe: Baseline and Week 2
|
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms.
Higher scores indicate more severe psychosomatic symptoms.
This outcome measures the change in PSSS total score from baseline to Week 2.
|
Baseline and Week 2
|
|
Change in Psychosomatic Symptoms Scale (PSSS) Total Score From Baseline to Week 6
Ramy czasowe: Baseline and Week 6
|
The Psychosomatic Symptoms Scale (PSSS) will be used to assess psychosomatic symptoms.
Higher scores indicate more severe psychosomatic symptoms.
This outcome measures the change in PSSS total score from baseline to Week 6.
|
Baseline and Week 6
|
|
Incidence of Adverse Events
Ramy czasowe: From Day 1 through Week 6
|
Adverse events will be recorded throughout the treatment and follow-up period.
The number and proportion of participants experiencing adverse events will be summarized.
The type, severity, duration, outcome, and relationship of adverse events to the intervention will be recorded.
|
From Day 1 through Week 6
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Brain Structural Imaging Metrics From 5.0T Magnetic Resonance Imaging
Ramy czasowe: Baseline and Day 6
|
Brain structural imaging metrics will be derived from 5.0T structural magnetic resonance imaging.
This outcome explores changes in brain structural imaging metrics from baseline to post-treatment.
|
Baseline and Day 6
|
|
Change in Resting-state Functional Connectivity From 5.0T Functional Magnetic Resonance Imaging
Ramy czasowe: Baseline and Day 6
|
Resting-state functional connectivity will be derived from 5.0T resting-state functional magnetic resonance imaging.
This outcome explores changes in resting-state functional connectivity from baseline to post-treatment.
|
Baseline and Day 6
|
|
Change in Diffusion Imaging Metrics From 5.0T Magnetic Resonance Imaging
Ramy czasowe: Baseline and Day 6
|
Diffusion imaging metrics will be derived from 5.0T diffusion magnetic resonance imaging.
This outcome explores changes in diffusion imaging metrics from baseline to post-treatment.
|
Baseline and Day 6
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Yonggui Yuan, PhD, Zhongda hospital
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Demchenko I, Rampersad S, Datta A, Horn A, Churchill NW, Kennedy SH, Krishnan S, Rueda A, Schweizer TA, Griffiths JD, Boyden ES, Santarnecchi E, Bhat V. Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder: a protocol for a randomized sham-controlled trial. Front Neurosci. 2024 Aug 29;18:1390250. doi: 10.3389/fnins.2024.1390250. eCollection 2024.
- Grossman N, Okun MS, Boyden ES. Translating Temporal Interference Brain Stimulation to Treat Neurological and Psychiatric Conditions. JAMA Neurol. 2018 Nov 1;75(11):1307-1308. doi: 10.1001/jamaneurol.2018.2760. No abstract available.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
30 maja 2026
Zakończenie podstawowe (Szacowany)
30 maja 2027
Ukończenie studiów (Szacowany)
30 maja 2027
Daty rejestracji na studia
Pierwszy przesłany
20 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
27 maja 2026
Pierwszy wysłany (Rzeczywisty)
28 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MR-32-25-078202
- 82271570 (Inny numer grantu/finansowania: National Natural Science Foundation of China)
- BF2025611 (Inny numer grantu/finansowania: Jiangsu Province Frontier Technology Research and Development Program (Health Sector))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Individual participant data will not be publicly shared because the study involves sensitive mental health information and neuroimaging data.
Data sharing may increase the risk of participant identification.
De-identified data may be made available from the principal investigator upon reasonable request and with approval from the ethics committee, when permitted by applicable regulations and the informed consent.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .