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

NCT ID: NCT06534684

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2029-02-12

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.

Conditions

Depression, Unipolar; Depression Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Intermittent Theta Burst Stimulation

Intervention Type: 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).

Sham 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.

Group Type: PLACEBO_COMPARATOR

Intermittent Theta Burst Stimulation

Intervention Type: 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).

Interventions

Intermittent 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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UiT The Arctic University of Norway

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Per Aslaksen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital North Norway

Tromsø, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Per M Aslaksen, PhD

Role: CONTACT

per.aslaksen@unn.no

77649234 ext. +47

Marte C Ørbo, PhD

Role: CONTACT

marte.c.orbo@uit.no

77645333 ext. +47

Facility Contacts

Ole Grønli, MD, PhD

Role: primary

ole.k.gronli@unn.no

References

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.

Reference Type: DERIVED

PMID: 39529199 (View on PubMed)

Other Identifiers

715272

Identifier Type: -

Identifier Source: org_study_id