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Major DepressionNCT07181226

High-Frequency vs. Theta-Burst TMS for Depression

A study testing High-frequency repetitive transcranial magnetic stimulation and Intermittent Theta Burst Stimulation in people with Major Depression, run by Krajská zdravotní, a.s. - Nemocnice Most, o.z. at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial was to learn if two different types of repetitive transcranial magnetic stimulation (rTMS) could help treat depression and anxiety in adults with major depressive disorder. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Major Depression
What is being tested?
High-frequency repetitive transcranial magnetic stimulation and Intermittent Theta Burst Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteCzechia
Study dates
1 May 2022to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 to 90 years.
  • Current major depressive disorder (MDD) as the primary diagnosis, confirmed according to the International Classification of Diseases, 10th Revision (ICD-10).
  • All participants had to be evaluated by a board-certified psychiatrist trained in rTMS to confirm eligibility.
  • Ability and willingness to provide written informed consent prior to study participation.

Who cannot join

  • Presence of ferromagnetic or electronic implants in the head or neck (e.g., pacemakers, aneurysm clips, cochlear implants, deep brain stimulators).
  • Known seizure disorders (such as epilepsy) or significantly increased risk of seizures.
  • Other major neurological diseases or conditions that would interfere with safe rTMS administration.
  • Active psychotic symptoms or a primary psychotic disorder.
  • Acute manic episode or recent hospitalization for mania or other severe psychiatric instability.
  • Ongoing electroconvulsive therapy (ECT) treatment.
Show all 9Show fewer
  • Medication changes made during the study.
  • Inability to comply with the treatment schedule (e.g., attendance problems, logistical barriers).
  • Any medical or psychiatric condition judged by the investigators to compromise safety or data integrity.

Trial locations and contacts

1 site in 1 country.

Czechia1 site
  • Krajská zdravotní, a.s. - Nemocnice Most, o.z.

    Most, Ústí nad Labem Region, 434 64

Other trials in Czechia

About this study

Official title: High-Frequency vs. Theta-Burst TMS in Depression: Head-to-Head Double-Blind Randomized Trial With Six-week Follow-up

The goal of this clinical trial was to learn if two different types of repetitive transcranial magnetic stimulation (rTMS) could help treat depression and anxiety in adults with major depressive disorder.

The main questions it aimed to answer were:

Read more

Did high-frequency rTMS and intermittent theta-burst stimulation (iTBS) both reduce depressive symptoms? Did one treatment lead to greater improvement in anxiety symptoms?

Researchers compared people receiving high-frequency rTMS to those receiving iTBS to see if one worked better for mood and anxiety symptoms.

Participants:

Were randomly assigned to one of the two treatment groups. Received 10 stimulation sessions over two weeks (five sessions per week). Completed questionnaires and interviews on depression, anxiety, and stress before treatment, after two weeks, and again six weeks later.

Read the detailed description

This randomized, double-blind clinical trial evaluated two established repetitive transcranial magnetic stimulation (rTMS) protocols-high-frequency rTMS (HF-rTMS) and intermittent theta-burst stimulation (iTBS)-delivered in a shortened, two-week treatment schedule for adults with major depressive disorder (MDD). The purpose was to determine whether a condensed regimen could provide effective relief of depressive and anxiety symptoms while improving treatment feasibility.

Design and Intervention A total of 108 participants with a primary diagnosis of MDD were randomized in a 1:1 ratio to receive either HF-rTMS (10 Hz stimulation) or iTBS, both targeting the left dorsolateral prefrontal cortex (DLPFC). Treatments were administered over 10 sessions in two consecutive weeks (five sessions per week).

HF-rTMS protocol: 1500 pulses per session at 10 Hz, delivered in 10 trains of 15 seconds each with 50-second inter-train intervals. Total session time: approximately 12.5 minutes.

iTBS protocol: 600 pulses per session, delivered as bursts of three 50 Hz pulses repeated at 200 ms intervals, with 2-second trains and 8-second inter-train intervals. Total session time: approximately 3 minutes and 20 seconds.

Stimulation intensity for both protocols was set at 100% of the participant's individual resting motor threshold.

Blinding and Assessments The trial employed a double-blind design: participants, clinical evaluators, and most research staff were unaware of treatment allocation. Independent clinicians performed structured interviews and validated rating scales before treatment (baseline), after two weeks of treatment, and at six-week follow-up.

Outcomes and Rationale The primary outcomes were changes in depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD) and the Zung Self-Rating Depression Scale (SDS), and changes in anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAMA) and the Beck Anxiety Inventory (BAI). Secondary outcomes included perceived stress and self-reported depressive symptomatology.

This study was motivated by clinical and logistical considerations: standard rTMS protocols often require 4-6 weeks of treatment, which can be burdensome for patients and health systems. Evidence suggests that much of the therapeutic response occurs within the first 10-15 sessions, raising the possibility that shorter regimens may capture the critical therapeutic window.

By directly comparing HF-rTMS and iTBS within a condensed protocol, this trial aimed to clarify their relative antidepressant and anxiolytic efficacy, evaluate the durability of short-course treatment, and inform optimized approaches to neuromodulation in depression.

Being tested
High-frequency repetitive transcranial magnetic stimulation, Intermittent Theta Burst Stimulation
Keywords
TMS, iTBS, Transcranial magnetic stimulation, Theta burst stimulation, depression, anxiety, RCT
Medical subject headings
Depressive Disorder, Major, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-frequency repetitive transcranial magnetic stimulationDevice

    High-frequency rTMS was delivered to the left dorsolateral prefrontal cortex using the 5 cm rule to localize the target site. Stimulation intensity was set at 100% of the resting motor threshold, determined by visible motor-evoked potentials in the right abductor pollicis brevis muscle. Each session consisted of 1500 pulses at 10 Hz, organized into 10 trains of 15 seconds (150 pulses per train) with 50-second inter-train intervals. Total stimulation time per session was approximately 12.5 minutes. A figure-of-eight coil (70BFX-LQC, Deymed Diagnostics) connected to a DuoMagXT-100 stimulator was used, with the coil positioned at ~45° from the midline, handle pointing posterolaterally.

  • Intermittent Theta Burst StimulationDevice

    Intermittent theta-burst stimulation (iTBS) was delivered to the left dorsolateral prefrontal cortex using the 5 cm rule for target localization. Stimulation intensity was set at 100% of the resting motor threshold, determined by motor-evoked potentials in the right abductor pollicis brevis muscle. Each session consisted of 600 pulses delivered in bursts of three 50 Hz pulses repeated every 200 ms. Trains of 2 seconds were followed by 8-second inter-train intervals. Total stimulation time per session was approximately 3 minutes and 20 seconds. A figure-of-eight coil (70HF-LQC, Deymed Diagnostics) connected to a DuoMagXT-100 stimulator was used, with coil orientation ~45° from the midline, handle pointing posterolaterally.

Study groups in NCT07181226
Study groupRoleWhat they receive
HF-rTMSActive comparatorHigh-frequency rTMS was delivered to the left dorsolateral prefrontal cortex using the 5 cm rule to localize the target site. Stimulation intensity was set at 100% of the resting motor threshold, determined by visible motor-evoked potentials in the right abductor pollicis brevis muscle. Each session consisted of 1500 pulses at 10 Hz, organized into 10 trains of 15 seconds (150 pulses per train) with 50-second inter-train intervals. Total stimulation time per session was approximately 12.5 minutes. A figure-of-eight coil (70BFX-LQC, Deymed Diagnostics) connected to a DuoMagXT-100 stimulator was used, with the coil positioned at ~45° from the midline, handle pointing posterolaterally.
Receives: Device: High-frequency repetitive transcranial magnetic stimulation
iTBSActive comparatorIntermittent theta-burst stimulation (iTBS) was delivered to the left dorsolateral prefrontal cortex using the 5 cm rule for target localization. Stimulation intensity was set at 100% of the resting motor threshold, determined by motor-evoked potentials in the right abductor pollicis brevis muscle. Each session consisted of 600 pulses delivered in bursts of three 50 Hz pulses repeated every 200 ms. Trains of 2 seconds were followed by 8-second inter-train intervals. Total stimulation time per session was approximately 3 minutes and 20 seconds. A figure-of-eight coil (70HF-LQC, Deymed Diagnostics) connected to a DuoMagXT-100 stimulator was used, with coil orientation ~45° from the midline, handle pointing posterolaterally.
Receives: Device: Intermittent Theta Burst Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Zung Self-Rating Depression Scale (SDS)

    A 20-item self-reported questionnaire measuring depressive symptoms. Each item is scored 1-4, yielding a total raw score range of 20-80. Standardized scores are calculated by multiplying the raw score by 1.25, with higher scores reflecting greater severity of depression (≥50 = clinically significant depression).

    Measured: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.

  2. Hamilton Depression Rating Scale (HAMD)

    A structured interview conducted by a trained clinician to assess severity of depressive symptoms. The HAMD contains 17-21 items scored from 0 (absent) to 2 or 4 (severe), depending on the item. The total score ranges from 0 to 52, with higher scores indicating more severe depression. Common interpretation: 0-7 = normal, 8-16 = mild depression, 17-23 = moderate, ≥24 = severe.

    Measured: From baseline (before treatment) to post-treatment at 2 weeks and follow-up at 6 weeks.

  3. Beck Anxiety Inventory (BAI)

    A 21-item self-reported questionnaire assessing common symptoms of anxiety. Each item is rated 0 (not at all) to 3 (severe), with a total score range of 0 to 63. Higher scores indicate more severe anxiety (0-7 = minimal, 8-15 = mild, 16-25 = moderate, 26-63 = severe).

    Measured: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.

  4. Hamilton Anxiety Rating Scale (HAMA)

    A clinician-rated scale that assesses severity of anxiety symptoms. It has 14 items, each rated from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, with higher scores indicating greater anxiety (≤17 = mild, 18-24 = moderate, 25-30 = severe). Includes subscores for psychological and somatic anxiety.

    Measured: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.

Secondary outcomes (2)
  1. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)

    A 16-item self-report scale assessing core symptoms of depression such as mood, sleep, appetite, and concentration. Each item is scored 0-3, with total scores ranging from 0 to 27. Higher scores represent greater severity (1-5 = mild, 6-10 = moderate, 11-15 = moderately severe, 16-20 = severe, ≥21 = very severe).

    Measured: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.

  2. Perceived Stress Scale (PSS)

    A 10-item self-report questionnaire measuring the degree to which participants perceive life situations as stressful. Each item is rated 0 (never) to 4 (very often), with total scores ranging from 0 to 40. Higher scores reflect higher perceived stress (0-13 = low, 14-26 = moderate, 27-40 = high stress).

    Measured: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2025
  2. Study start1 May 2022
  3. Primary completion31 Dec 2024
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07181226
Sponsor's protocol ID
TMS-RCT-KZCR
Status last verified
Sep 2025
First submitted
12 Sep 2025
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. The main reasons are protection of participant privacy and confidentiality, as well as limitations in the consent form that did not include permission for public data sharing. Aggregate results are available in the published manuscript and can be provided upon reasonable request to the corresponding author.

Questions about this trial

What is this clinical trial studying?

A study testing High-frequency repetitive transcranial magnetic stimulation and Intermittent Theta Burst Stimulation in people with Major Depression, run by Krajská zdravotní, a.s. - Nemocnice Most, o.z. at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Zung Self-Rating Depression Scale (SDS) (time frame: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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