The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial
University Hospital of North Norway
50 participants
Feb 12, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria17
- 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
Interventions
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).
Locations(1)
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NCT06534684