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

NCT06534684 | Recruiting

• 1 other identifier: 715272
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar; Depression Moderate

Outcome Measures

Primary Outcomes (3)

• Data from magnetic resonance imaging - white matter integrity

  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).

  Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days

• Data from magnetic resonance imaging - cortical thickness

  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).

  Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days

• Data from magnetic resonance imaging - cerebral activity

  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).

  Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days

Secondary Outcomes (1)

• Performance on a N-back cognitive test

  Change from the pretest to the posttest after 10 treatments with iTBS, an average of 15 days

Study Arms (2)

Intermittent Theta Burst Stimulation

ACTIVE COMPARATOR

Stimulation will be performed with a Mag \& More PowerMag EEG 100 system with a double PMD70 p-cool (fluid-cooled) figure-of-eight coil.

Device: Intermittent Theta Burst Stimulation

Sham Intermittent Theta Burst Stimulation

PLACEBO COMPARATOR

Sham stimulation will be performed by the Mag \& More PowerMag EEG 100 system double PMD70 p-cool figure-of-eight coil Sham system.

Device: Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation DEVICE

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).

Intermittent Theta Burst Stimulation; Sham Intermittent Theta Burst Stimulation

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• UiT The Arctic University of Norway: collaborator

Study Sites (1)

University Hospital North Norway

Tromsø, 9038, Norway

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Central Study Contacts

Per M Aslaksen, PhD

CONTACT

77649234; per.aslaksen@unn.no

Marte C Ørbo, PhD

CONTACT

77645333; marte.c.orbo@uit.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: August 2, 2024
• Study Start: February 12, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): February 12, 2029
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be published after completion of the study. The study protocol will be published as soon as possible.

Locations

NO (1)