Actively Recruiting

Phase Not Applicable
Age: 22Years - 65Years
All Genders
ID06534684

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

Led by University Hospital of North Norway · Updated on 2024-08-02

50

Participants Needed

1

Research Sites

193 weeks

Total Duration

On this page

Sponsors

U

University Hospital of North Norway

Lead Sponsor

U

UiT The Arctic University of Norway

Collaborating Sponsor

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

Who Can Participate

Age: 22Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

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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)

Trial Site Locations

Total: 1 location

1

University Hospital North Norway

Tromsø, Norway, 9038

Actively Recruiting

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Research Team

P

Per M Aslaksen, PhD

M

Marte C Ørbo, PhD

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.

Marte C Ørbo, Sabine Høier, Torgil R Vangberg...

https://pubmed.ncbi.nlm.nih.gov/39529199