The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
Recruiting · NCT06534684 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital of North Norway
View the official record on ClinicalTrials.gov →Interventions studied
Intermittent Theta Burst Stimulation
What this trial is about
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.
Who can take part
Age range
22 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- University Hospital North Norway - Tromsø, Norway