Neuronavigation Guided iTBS With Personalized Target for Depression

NCT ID: NCT05577481

Last Updated: 2024-05-23

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-08-31

Brief Summary

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The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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).

Group Type SHAM_COMPARATOR

sham iTBS combined with antidepressants

Intervention Type COMBINATION_PRODUCT

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).

Group Type EXPERIMENTAL

iTBS combined with antidepressants

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type COMBINATION_PRODUCT

iTBS combined with antidepressants

Two sessions of prolonged iTBS (1800 pulses) per day over 10 days combined with antidepressants.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* 18 to 60 years old
* 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

* any other current or past psychiatric axis-I or axis-II disorders
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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XijingH

Xi'an, Shaan'xi, China

Site Status

Countries

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China

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.

Reference Type DERIVED
PMID: 39515856 (View on PubMed)

Other Identifiers

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XJLL-KY20222111

Identifier Type: -

Identifier Source: org_study_id

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