High-Frequency vs. Theta-Burst TMS for Depression

NCT07181226 | Completed

• 1 other identifier: TMS-RCT-KZCR
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aimed to answer were: 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.

Conditions

Major Depression

Keywords

TMS; iTBS; Transcranial magnetic stimulation; Theta burst stimulation; depression; anxiety; RCT

Outcome Measures

Primary Outcomes (4)

• 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).

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

• 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.

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

• 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).

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

• 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.

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

Secondary Outcomes (2)

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)

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

• Perceived Stress Scale (PSS)

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

Study Arms (2)

HF-rTMS

ACTIVE COMPARATOR

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.

Device: High-frequency repetitive transcranial magnetic stimulation

iTBS

ACTIVE COMPARATOR

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.

Device: Intermittent Theta Burst Stimulation

Interventions

High-frequency repetitive transcranial magnetic stimulation DEVICE

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.

HF-rTMS

Intermittent Theta Burst Stimulation DEVICE

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.

iTBS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Krajská zdravotní, a.s. - Nemocnice Most, o.z.: lead

Study Sites (1)

Krajská zdravotní, a.s. - Nemocnice Most, o.z.

Most, Ústecký kraj, 434 64, Czechia

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jakub Albrecht, MD, Ph.D.

  Department of Psychiatry, Most Hospital, Krajská zdravotní a.s., Most, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study used a double-blind design. Participants were randomly assigned to receive either high-frequency rTMS or intermittent theta-burst stimulation but were not told which protocol they received. Clinical evaluators and most research staff involved in assessments were also blinded to treatment allocation. Only the technicians administering stimulation knew the protocol, and they were not involved in outcome assessments. To maintain blinding, both groups were informed that they were receiving an established rTMS treatment, and clinical raters avoided discussing protocol details with participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: May 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)