Enrolling by invitation NCT07207239
Effect of Theta-burst rTMS Therapy on the Clinical and Cognitive Symptoms of Patients With Therapy Resistant Depression and Response Prediction With Neuroimaging Methods.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: repetative Transcranial Magnetic Stimulation (rTMS), theta-burst protocol.
- Who it may be relevant to
- Registry conditions: Transcranial Magnetic Stimulation, Repetitive, Depression - Major Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Clinical symptoms [Time frame: 120 days]
Secondary outcome measures (6)
- Neuroimaging characteristics [Time frame: 120 days]
- Patient profile [Time frame: 120 days]
- Cognitive functioning/Spatial working Memory [Time frame: 120 days]
- Cognitive functioning/Executive function [Time frame: 120 days]
- Cognitive functioning/reaction time [Time frame: 120 days]
- Clinical symptoms based on self-report questionnaires [Time frame: 120 days]
Eligibility criteria
Inclusion criteria
- diagnosis of depression
- 18 years of age
- Beck depression inventory score above 12 (screening)
- MADRS score above 6 (baseline)
Exclusion criteria
- serious cognitive impairment
- mental retardation
- history of head injury with loss of consciousness for more than 1 hour
- alcohol or drug abuse within the past 3 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Hungary · 1 center
- Department of Psychiatry and Psychotherapy — Budapest
Identifiers
NCT: NCT07207239 · TMS-DEP-2024