The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent Theta Burst Stimulation.
- Who it may be relevant to
- Registry conditions: Depression, Unipolar, Depression Moderate. Basic parameters: 22 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial
Overview
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
- Device Intermittent 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).
Primary outcome measures
- 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]
- 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]
- 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]
Secondary outcome measures (1)
- Performance on a N-back cognitive test [Time frame: Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- University Hospital North Norway — Tromsø
Publications
- Orbo MC, Hoier S, Vangberg TR, Csifcsak G, Gronli OK, Aslaksen PM. The cerebral and cognitive changes after intermittent theta burst stimulation (iTBS) treatment for depression: study protocol for a randomized double-blind sham-controlled trial. Trials. 2024 Nov 11;25(1):752. doi: 10.1186/s13063-024-08606-8. PMID 39529199
Identifiers
NCT: NCT06534684 · 715272