Evidence map›Paper›PMID 37784199›Full record

ArticleTrials2023

The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial.

Marte Christine Ørbo, Ole K Grønli, Camilla Larsen, Torgil R Vangberg, Oddgeir Friborg, Zsolt Turi, Matthias Mittner, Gabor Csifcsak, Per M Aslaksen

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05516095 (The Antidepressant Effect of Intermittent Theta Burst Stimulation), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05516095 nacompletednot on this map

The Antidepressant Effect of Intermittent Theta Burst Stimulation (iTBS) A Randomised Double-blind Sham-controlled Trial

TypeinterventionalSponsorUniversity Hospital of North NorwayRan2022 to 2025Enrolled73ConditionsDepression, Executive DysfunctionArmsTranscranial magnet stimulation, Sham Transcranial magnet stimulation
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Marte Christine ØrboDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of Norway, Huginbakken 32, Tromsø, N-9037, Norway. Marte.c.orbo@uit.no.ORCID http://orcid.org/0000-0002-2661-7098
Ole K GrønliDepartment of Clinical Medicine, Faculty of Health Sciences, UIT the Arctic University of Norway, Tromsø, Norway.
Camilla LarsenDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of Norway, Huginbakken 32, Tromsø, N-9037, Norway.
Torgil R VangbergDepartment of Clinical Medicine, Faculty of Health Sciences, UIT the Arctic University of Norway, Tromsø, Norway.
Oddgeir FriborgDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of Norway, Huginbakken 32, Tromsø, N-9037, Norway.
Zsolt TuriDepartment of Neuroanatomy, Institute for Anatomy and Cell Biology, University of Freiburg, Freiburg, Germany.
Matthias MittnerDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of Norway, Huginbakken 32, Tromsø, N-9037, Norway.
Gabor CsifcsakDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of Norway, Huginbakken 32, Tromsø, N-9037, Norway.
Per M AslaksenDepartment of Psychology, Faculty of Health Sciences, UIT the Arctic University of Norway, Huginbakken 32, Tromsø, N-9037, Norway.
UiT The Arctic University of Norway · NOUniversity Hospital of North Norway · NOUniversity of Freiburg · DE

Funding

Helse Nord RHF HNF1578-21
6 · The paper itself

Abstract

backgroundIntermittent theta burst stimulation (iTBS) when applied over the left dorsolateral prefrontal cortex (DLPFC) has been shown to be equally effective and safe to treat depression compared to traditional repetitive transcranial magnetic stimulation (rTMS) paradigms. This protocol describes a funded single-centre, double-blind, randomized placebo-controlled, clinical trial to investigate the antidepressive effects of iTBS and factors associated with an antidepressive response.

methodsIn this trial, outpatients (N = 96, aged 22-65 years) meeting the diagnostic criteria for at least moderate depression (Montgomery and Aasberg Depression Rating Scale score ≥ 20) will be enrolled prospectively and receive ten, once-a-day sessions of either active iTBS or sham iTBS to the left DLPFC, localized via a neuronavigation system. Participants may have any degree of treatment resistance. Prior to stimulation, participants will undergo a thorough safety screening and a brief diagnostic assessment, genetic analysis of brain-derived neurotropic factor, 5-HTTLPR and 5-HT1A, and cerebral MRI assessments. A selection of neuropsychological tests and questionnaires will be administered prior to stimulation and after ten stimulations. An additional follow-up will be conducted 4 weeks after the last stimulation. The first participant was enrolled on June 4, 2022. Study completion will be in December 2027. The project is approved by the Regional Ethical Committee of Medicine and Health Sciences, Northern Norway, project number 228765. The trial will be conducted according to Good Clinical Practice and published safety guidelines on rTMS treatment. DISCUSSION: The aims of the present trial are to investigate the antidepressive effect of a 10-session iTBS protocol on moderately depressed outpatients and to explore the factors that can explain the reduction in depressive symptoms after iTBS but also a poorer response to the treatment. In separate, but related work packages, the trial will assess how clinical, cognitive, brain imaging and genetic measures at baseline relate to the variability in the antidepressive effects of iTBS.

trial registrationClinicalTrials.gov NCT05516095. Retrospectively registered on August 25, 2022.

Indexed as

Prefrontal CortexTranscranial Magnetic StimulationAntidepressive AgentsBrainDouble-Blind MethodHumansRandomized Controlled Trials as TopicAntidepressive AgentsCognitionDepressionGenetic factorsIntermittent theta burst stimulationMagnetic resonance imagingRandomized controlled trial

Identifiers

PMID37784199
PMCPMC10546766
OpenAlexW4387253198

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.