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Brain and Thinking Changes After Magnetic Stimulation for Depression

Tests repeated magnetic brain stimulation against a sham treatment in adults with moderate depression.

Plain-language title generated from the registry record
Registry title: The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression

Key facts

Where
Tromsø, NorwaySee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 22 and 65 years old?

Source: NCT06534684, who can take part

Where in Norway

  • University Hospital North NorwayTromsø, NorwayTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University Hospital of North Norway
Trial code
NCT06534684
Record updated
2 August 2024
Original description
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.Read full original descriptionShow less

The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression A Randomised Double-blind Sham-controlled Trial

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.

Inclusion: 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: The current episode fulfills the criteria for a major depressive episode requiring inpatient treatment and/or electroconvulsive therapy,; Currently using of antipsychotic medication or benzodiazepines - or any medication that interferes with motor threshold excitability; Bipolar disorder; Borderline personality disorder; Current eating disorders; Obsessive- compulsive disorders; Post-traumatic stress disorder; A life-time medical history of seizure; Cardiac or systemic disease; The current depressive episode is in the mild range; The current depressive episode is clearly triggered by grief or a recent major stressful life event; Psychotic symptoms; Alcohol or substance abuse/addiction in the last 6 months; Neurological or neurosurgical pathologies; Metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.); Autism; Pregnancy.

ClinicalTrials.gov NCT06534684