RecruitingNot ApplicableNCT06534684

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


Sponsor

University Hospital of North Norway

Enrollment

50 participants

Start Date

Feb 12, 2024

Study Type

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

Min Age: 22 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study examines how a brain stimulation treatment called iTBS (intermittent theta burst stimulation) — a quick, non-invasive form of magnetic brain stimulation — affects the brain and thinking abilities of people with moderate depression. iTBS is delivered using a coil placed on the scalp and is already used as a treatment, but researchers want to understand exactly what brain changes it causes and whether these changes are linked to improvements in mood and thinking. **You may be eligible if...** - You have been diagnosed with at least moderate depression - Your current depressive episode has lasted more than 2 weeks but less than 2 years - Your medication has been stable for at least 3 weeks before starting treatment - You are able and willing to follow the treatment schedule and safely undergo MRI and brain stimulation **You may NOT be eligible if...** - Your depression is currently mild - Your depression is severe enough to require inpatient hospital care or electroconvulsive therapy (ECT) - Your depression appears to be triggered by grief or a major recent stressful event - You have bipolar disorder, borderline personality disorder, psychotic symptoms, current alcohol or substance abuse, eating disorders, OCD, or PTSD - You have a history of seizures or neurological conditions - You have a pacemaker or metal implants in your body - You are currently taking antipsychotic medications or benzodiazepines - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntermittent 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).


Locations(1)

University Hospital North Norway

Tromsø, Norway

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NCT06534684


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