Evidence map›Paper›PMID 41419288›Full record

ArticleBMJ open2025

The MenoStim Trial: Study Protocol for a Randomised, Sham-Controlled, Double-Blinded, Pilot Clinical Trial Exploring the Neurophysiological, Cognitive, Mood and Biochemical Effects Associated with Non-Invasive Brain Stimulation During the Menopause Transition.

Najwa-Joelle Metri, Rocco Cavaleri, Ghufran Alhassani, Carolyn Ee, Chai K Lim, Heather M Francis, Daniel Hochstrasser, Rose Mery Bou Merhy, Genevieve Z Steiner-Lim

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Najwa-Joelle MetriNICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
Rocco CavaleriNICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.ORCID http://orcid.org/0000-0001-9499-1703
Ghufran AlhassaniBrain Stimulation and Rehabilitation (BrainStAR Lab), School of Health Sciences, Western Sydney University, Sydney, NSW, Australia.
Carolyn EeNICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
Chai K LimDepartment of Child and Adolescent Psychiatry, Psychosomatic Medicine and Psychotherapy, Jena University Hospital, Jena, Germany.
Heather M FrancisSchool of Psychological Sciences, Macquarie University, Macquarie Park, NSW, Australia.
Daniel HochstrasserNICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
Rose Mery Bou MerhyNICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia.
Genevieve Z Steiner-LimNICM Health Research Institute, Western Sydney University, Penrith, NSW, Australia G.Steiner@westernsydney.edu.au.ORCID http://orcid.org/0000-0002-8708-6104

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIntermittent theta-burst stimulation (iTBS) is a non-invasive brain stimulation technique that has been shown to improve cognition and mood when applied to certain brain structures and regions. Despite research demonstrating that iTBS may have clinical utility in treating cognitive and mood changes, no study has yet been conducted to explore the potential to modulate the neurophysiological changes that can underpin cognitive and mood changes during the menopause transition. Cognitive and psychological symptoms are commonly reported by females experiencing the menopause transition, and it is thought that these symptoms arise due to various neurophysiological, metabolic and endocrinological changes. Despite being common, there is a lack of treatments available for managing these symptoms and a scarcity of data regarding the mechanisms by which they occur. METHODS AND ANALYSIS: The aim of this 5-week randomised, sham-controlled, double-blinded pilot clinical trial (n=72) is to assess the underlying mechanisms of action of iTBS in females in the late menopause transition and the relationship with cognition and mood. Data will be analysed using Stata ETHICS AND DISSEMINATION: The study protocol has been reviewed and ethically approved by the Western Sydney University Human Research Ethics Committee (H16200; 8 November 2024). All participants will provide written informed consent prior to enrolment. Results from this trial will be disseminated via peer-reviewed publications and conference presentations, with findings shared in accordance with open science and data transparency principles. ANZCTR REGISTRATION NUMBER: ACTRN12625000030471, Australian New Zealand Clinical Trials Registry.

Indexed as

AffectCognitionMenopauseTranscranial Magnetic StimulationAdultBrainDouble-Blind MethodFemaleHumansMiddle AgedPilot ProjectsRandomized Controlled Trials as TopicResearch DesignAgingBrainCognitionDepression & mood disordersElectroencephalographyTranscranial Magnetic Stimulation

Identifiers

PMID41419288
PMCPMC12716591

What Socratic holds

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LicenceCC BY
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Registered trials

None linked

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 Socratic graph.