High-Frequency vs. Theta-Burst TMS for Depression
- Conditions
- Major Depression
- Registration Number
- NCT07181226
- Lead Sponsor
- Krajská zdravotní, a.s. - Nemocnice Most, o.z.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Zung Self-Rating Depression Scale (SDS) From baseline to post-treatment at 2 weeks and follow-up at 6 weeks. 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).
Hamilton Depression Rating Scale (HAMD) From baseline (before treatment) to post-treatment at 2 weeks and follow-up at 6 weeks. 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.
Beck Anxiety Inventory (BAI) From baseline to post-treatment at 2 weeks and follow-up at 6 weeks. 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).
Hamilton Anxiety Rating Scale (HAMA) From baseline to post-treatment at 2 weeks and follow-up at 6 weeks. 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.
- Secondary Outcome Measures
Name Time Method Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16) From baseline to post-treatment at 2 weeks and follow-up at 6 weeks. 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).
Perceived Stress Scale (PSS) From baseline to post-treatment at 2 weeks and follow-up at 6 weeks. 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).
Trial Locations
- Locations (1)
Krajská zdravotní, a.s. - Nemocnice Most, o.z.
🇨🇿Most, Ústecký kraj, Czechia
Krajská zdravotní, a.s. - Nemocnice Most, o.z.🇨🇿Most, Ústecký kraj, Czechia