The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression, Unipolar
- Sponsor
- University Hospital of North Norway
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Data from magnetic resonance imaging - white matter integrity
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Per Aslaksen
Professor
University Hospital of North Norway
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Data from magnetic resonance imaging - white matter integrity
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Performance on a N-back cognitive test(Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days)