Depression Moderate, Depression, Unipolar
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntermittent Theta Burst Stimulation
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).
Sponsors
UiT The Arctic University of Norway
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients must meet the diagnostic criteria of at least a moderate depression * The duration of the current depressive episode must have lasted more than 2 weeks but less than 2 years * Drug therapy must have been stable for the last three weeks prior to the first treatment day with iTBS * Patients must volunteer to provide informed consent, be able to follow the treatment schedule and have a satisfactory safety screening for iTBS and MRI
Exclusion criteria
* The current depressive episode is in the mild range * The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy, * The current depressive episode is clearly triggered by grief or a recent major stressful life event * Bipolar disorder * Borderline personality disorder * Psychotic symptoms * Alcohol or substance abuse/addiction in the last 6 months * Current eating disorders * Obsessive- compulsive disorders * Post-traumatic stress disorder * A life-time medical history of seizure * Neurological or neurosurgical pathologies * Cardiac or systemic disease * Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.) * Autism * Pregnancy * Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data from magnetic resonance imaging - white matter integrity | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days | 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). |
| Data from magnetic resonance imaging - cortical thickness | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days | 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). |
| Data from magnetic resonance imaging - cerebral activity | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance on a N-back cognitive test | Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days | 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. |
Countries
Norway
Contacts
Primary ContactPer M Aslaksen, PhD
Backup ContactMarte C Ørbo, PhD
Outcome results
None listed