The Cerebral and Cognitive Changes After Intermittent Theta Burst Stimulation (iTBS) Treatment for Depression

Not Applicable

Recruiting

• Conditions: Depression Moderate; Depression, Unipolar
• Interventions: Device: Intermittent Theta Burst Stimulation

• Registration Number: NCT06534684
• Lead Sponsor: University Hospital of North Norway

Brief 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.

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.

Study Timeline

• Study Start: 2024-02-12
• Study First Submitted: 2024-05-25
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-02
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-06
• Study Completion: 2029-02-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Theta Burst Stimulation	Intermittent Theta Burst Stimulation	Stimulation will be performed with a Mag \& More PowerMag EEG 100 system with a double PMD70 p-cool (fluid-cooled) figure-of-eight coil.
Sham Intermittent Theta Burst Stimulation	Intermittent Theta Burst Stimulation	Sham stimulation will be performed by the Mag \& More PowerMag EEG 100 system double PMD70 p-cool figure-of-eight coil Sham system.

Primary Outcome Measures

Name	Time	Method
Data from magnetic resonance imaging - white matter integrity	Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days	Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of cerebral white matter integrity quantified by fractional anisotropy measured by diffusion tensor imaging (DTI) obtained from magnetic resonance imaging (MRI).
Data from magnetic resonance imaging - cortical thickness	Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days	Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in anatomical measures of thickness in cerebral gray matter thickness quantified by T1-weighted magnetic resonance imaging (MRI).
Data from magnetic resonance imaging - cerebral activity	Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days	Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in cerebral activity quantified by blood-oxygen-level-dependent (BOLD) responses measured by functional resonance imaging (fMRI).

Secondary Outcome Measures

Name	Time	Method
Performance on a N-back cognitive test	Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days	Differences between groups when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation in behavioral performance on a cognitive task measuring working memory and executive performance when comparing intermittent theta burst stimulation versus sham intermittent theta burst stimulation.

Trial Locations

Locations (1)

University Hospital North Norway; 🇳🇴 Tromsø, Norway