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Enrolling by Invitation

NCT Number: 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy

Budapest, Pest County, 1083, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. Clinical symptoms

    Time frame: 120 days

    The primary outcome measures are the clinical symptoms of depression measured by a clinician with the Montgomery-Åsberg Depression Rating Scale.

Secondary outcomes

  1. Neuroimaging characteristics

    Time frame: 120 days

    A secondary outcome measure is neuroimaging characteristics including the alpha peaks measured by EEG, the nonoscillatory component (1/f) calculated from resting EEG, and connectivity parameters measured by fMRI. These markers will play a part in response prediction.

  2. Patient profile

    Time frame: 120 days

    The patient profile encompasses demographics and clinical characteristics, namely age, sex, level of education, history of other psychiatric conditions, comorbidities, and medications. Together with neuroimaging characteristics, these will be used for response prediction.

  3. Cognitive functioning/Spatial working Memory

    Time frame: 120 days

    The test will be used measure spatial working memory. Memory span is the major outcome variable of this test (the longest number of elements correctly retraced). Higher values indicate better outcomes. Its minimum value is 0 and it has no theoretical maximum value.

  4. Cognitive functioning/Executive function

    Time frame: 120 days

    The test will be used measure executive functioning. Number of mistakes is the major outcome variable of this test (mistakes arise when subjects fail to differentiate a distractor from the continuous task). Higher values indicate worse outcomes. Its minimum value is 0 and it has no theoretical maximum value.

    Time Frame: 120 days

  5. Cognitive functioning/reaction time

    Time frame: 120 days

    The test will be used measure executive functioning and reaction time. Average reaction time is the major outcome variable of this test. Higher values indicate worse outcomes.

  6. Clinical symptoms based on self-report questionnaires

    Time frame: 120 days

    Beck depression inventories are to be used to monitor clinical symptoms of depression

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Acronym: TMS-DEP-2024

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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