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| Name | Class |
|---|---|
| UiT The Arctic University of Norway | OTHER |
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The present project aims to assess the neurocognitive impact of a two-week once-a-day regimen of intermittent theta burst stimulation (iTBS) compared to sham iTBS, when targeting the left dorsolateral prefrontal cortex (LDLPFC) in clinically depressed outpatients. The study investigates the relationships between changes in cerebral measures and cognitive performance on an N-back task in relation to the antidepressive effect following iTBS.
The study is a randomized sham controlled double blind clinical trial in which the changes in cortical functions associated with the anti-depressive effect of two weeks of once-a-day neuronavigated iTBS over the left dorsolateral prefrontal cortex (LDLPFC) will be investigated in comparison to sham iTBS. Participants will be recruited prospectively, and the study is performed at a single university hospital. After written informed consent is obtained from eligible, volunteering patients, baseline measurements will be administrated, and the patient will be allocated to either sham or active iTBS once a day for 10 consecutive workdays. A total of three measurements will take place, namely at baseline prior to iTBS treatment, after two weeks with iTBS treatment (posttest) and four weeks after (follow-up). The primary outcome measures will be assessed from baseline to the posttest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Theta Burst Stimulation | Active Comparator | Stimulation will be performed with a Mag & More PowerMag EEG 100 system with a double PMD70 p-cool (fluid-cooled) figure-of-eight coil. |
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| Sham Intermittent Theta Burst Stimulation | Placebo Comparator | Sham stimulation will be performed by the Mag & More PowerMag EEG 100 system double PMD70 p-cool figure-of-eight coil Sham system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Theta Burst Stimulation | Device | Intermittent Theta Burst Stimulation will be delivered with 120% of resting motor threshold with triplet 50 Hz bursts repeated at 5 Hz; 2 seconds on and 8 s off, 600 pulses per session with a total duration of 3 min 9 s. Treatment will be provided for 10 days for two consecutive weeks (except Saturdays and Sundays). |
| Measure | Description | Time Frame |
|---|---|---|
| Data from magnetic resonance imaging - white matter integrity | Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of cerebral white matter integrity quantified by fractional anisotropy measured by diffusion tensor imaging (DTI) obtained from magnetic resonance imaging (MRI). | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days |
| Data from magnetic resonance imaging - cortical thickness | Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of thickness in cerebral gray matter thickness quantified by T1-weighted magnetic resonance imaging (MRI). | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days |
| Data from magnetic resonance imaging - cerebral activity | Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in cerebral activity quantified by blood-oxygen-level-dependent (BOLD) responses measured by functional resonance imaging (fMRI). | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on a N-back cognitive test | Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in behavioral performance on a cognitive task measuring working memory and executive performance when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation. | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Per M Aslaksen, PhD | Contact | 77649234 | +47 | per.aslaksen@unn.no |
| Marte C Ørbo, PhD | Contact | 77645333 | +47 | marte.c.orbo@uit.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital North Norway | Recruiting | Tromsø | 9038 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39529199 | Derived | Orbo MC, Hoier S, Vangberg TR, Csifcsak G, Gronli OK, Aslaksen PM. The cerebral and cognitive changes after intermittent theta burst stimulation (iTBS) treatment for depression: study protocol for a randomized double-blind sham-controlled trial. Trials. 2024 Nov 11;25(1):752. doi: 10.1186/s13063-024-08606-8. |
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Anonymised data will be made available to other researchers when the study has ended.
Data will be published after completion of the study. The study protocol will be published as soon as possible.
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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