Study of Brain and Thinking Changes After Two Weeks of Intermittent Theta Burst Stimulation iTBS Treatment for Moderate Depression
Led by University Hospital of North Norway · Updated on 2024-08-02
50
Participants Needed
1
Research Sites
193 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the brain and cognitive effects of intermittent theta burst stimulation iTBS in adults with moderate depression. This study compares a two-week daily treatment of neuronavigated iTBS targeting the left dorsolateral prefrontal cortex with a sham treatment. The goal is to understand how changes in brain activity relate to cognitive performance and the antidepressant effects of iTBS.
Participants will receive either active iTBS or sham stimulation once a day for 10 consecutive workdays, excluding weekends. The iTBS treatment involves delivering bursts of magnetic pulses using a specialized device with a fluid-cooled figure-of-eight coil. Sham stimulation uses a similar device but without active pulses. The study is randomized, double-blind, and controlled by sham treatment.
Participants will undergo three assessments before treatment, immediately after the two-week treatment period, and four weeks later. Researchers will use magnetic resonance imaging MRI to measure changes in white matter integrity, cortical thickness, and cerebral activity. Cognitive performance will be tested using an N-back task. These measurements will help link brain changes with treatment effects over about 15 days of therapy.
CONDITIONS
Brief Title
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
Research Team
P
Per M Aslaksen, PhD
M
Marte C Ørbo, PhD
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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
You will not qualify if you...
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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 weeks
Participants receive daily neuronavigated intermittent theta burst stimulation (iTBS) or sham treatment over the left dorsolateral prefrontal cortex for 10 consecutive weekdays.
10 visits (in-person, weekdays)
Follow-up
Duration - 4 weeks
Participants are monitored with assessments four weeks after treatment completion to evaluate cerebral and cognitive changes.
1 visit (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The cerebral and cognitive changes after intermittent theta burst stimulation (iTBS) treatment for depression: study protocol for a randomized double-blind sham-controlled trial.