Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods. (TMS-DEP-2024)

Semmelweis University

Status: Invitation-only

Conditions: Transcranial Magnetic Stimulation, Repetitive; Depression - Major Depressive Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07207239

TMS-DEP-2024

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

TB-rTMS

Experimental group

Treatment:

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