Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods.

NCT ID: NCT07207239

Last Updated: 2025-10-03

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

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-13

Study Completion Date

2028-06-13

Brief Summary

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The primary aim of the study is to find the combination of neuroimaging-related markers, demographics, and clinical characteristics that predict the response of patients with therapy-resistant depression to theta-burst rTMS treatment. The secondary aim is to monitor the cognitive effects of TMS therapy.

Detailed Description

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Conditions

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Transcranial Magnetic Stimulation, Repetitive Depression - Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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TB-rTMS

Group Type EXPERIMENTAL

repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol

Intervention Type DEVICE

Theta-burst rTMS treatment stimulates the left Dorsolateral Prefrontal Cortex (DLPFC). The TBS parameters the investigators adopted follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 100% active motor threshold. The investigators plan to deliver 1800 stimuli to the left DLPFC daily in 9.5-minute blocks for four weeks.

Interventions

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repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol

Theta-burst rTMS treatment stimulates the left Dorsolateral Prefrontal Cortex (DLPFC). The TBS parameters the investigators adopted follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 100% active motor threshold. The investigators plan to deliver 1800 stimuli to the left DLPFC daily in 9.5-minute blocks for four weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. diagnosis of depression
2. 18 years of age
3. Beck depression inventory score above 12 (screening)
4. MADRS score above 6 (baseline)

Exclusion Criteria

1. serious cognitive impairment
2. mental retardation
3. history of head injury with loss of consciousness for more than 1 hour
4. alcohol or drug abuse within the past 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University

OTHER

Sponsor Role lead

Responsible Party

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Gábor Csukly

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Psychiatry and Psychotherapy

Budapest, Pest County, Hungary

Site Status

Countries

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Hungary

Other Identifiers

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TMS-DEP-2024

Identifier Type: -

Identifier Source: org_study_id

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