Neuronavigation Guided iTBS With Personalized Target for Depression
NCT ID: NCT05577481
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
68 participants
INTERVENTIONAL
2023-07-10
2024-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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functional MRI-guided iTBS(sham group)
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
sham iTBS combined with antidepressants
Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
functional MRI-guided iTBS (pgACC-DLPFC)
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
iTBS combined with antidepressants
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
Interventions
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sham iTBS combined with antidepressants
Two sessions of sham prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
iTBS combined with antidepressants
Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.
Eligibility Criteria
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Inclusion Criteria
* Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
* Meet the threshold on the total HAMD17 score of \>17 at both screening and baseline visits
* Able to provide informed consent
Exclusion Criteria
* severe physical illnesses
* psychotic symptoms, alcohol or drug abuse
* A history of neurological disorders including seizure, cerebral trauma
* MRI evidence of structural brain abnormalities
* Contraindications to MRI and rTMS
* Acute suicide
* Female that is pregnant or breastfeeding
18 Years
60 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Locations
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XijingH
Xi'an, Shaan'xi, China
Countries
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References
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Liu N, Zhao N, Tang N, Cai M, Zhang Y, Lv R, Zhang Y, Han T, Meng Y, Zang Y, Wang H. Safety and efficacy of individual target transcranial magnetic stimulation to stimulate the most negative correlate of DLPFC-pgACC in the treatment of major depressive disorder: study protocol of a double-blind, randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e081520. doi: 10.1136/bmjopen-2023-081520.
Other Identifiers
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XJLL-KY20222111
Identifier Type: -
Identifier Source: org_study_id
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