Evidence map›Paper›PMID 34383681›Full record

ArticleJMIR research protocols2021

Repeated Transcranial Magnetic Stimulation for Improving Cognition in Alzheimer Disease: Protocol for an Interim Analysis of a Randomized Controlled Trial.

Zahra Moussavi, Lisa Koski, Paul B Fitzgerald, Colleen Millikin, Brian Lithgow, Mohammad Jafari-Jozani, Xikui Wang

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

Article in JMIR research protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02908815 (Investigating the Effect of Repetitive Transcranial Magnetic Stimulation), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.1field-weighted citation impact, top 9% 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.

NCT02908815 nacompletednot on this map

Investigating the Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) as a Treatment for Alzheimer's Disease

TypeinterventionalSponsorUniversity of ManitobaRan2016 to 2022Enrolled200ConditionsAlzheimer's DiseaseArmsrTMS active treatment, rTMS sham treatment
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
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

7 authors at 3 institutions in 2 countries.

Zahra MoussaviBiomedical Engineering Program, Faculty of Engineering, University of Manitoba, Winnipeg, MB, Canada.ORCID https://orcid.org/0000-0001-9202-949X
Lisa Koski *McGill University, Montreal, QC, Canada.ORCID https://orcid.org/0000-0002-4135-5567
Paul B Fitzgerald *Department of Psychiatry, Epworth Center for Innovation in Mental Health, Monash University, Melbourne, Australia.ORCID https://orcid.org/0000-0003-4217-8096
Colleen Millikin *Department of Clinical Health Psychology, Max Rady College of Medicine, University of Manitoba, Winnipeg, MB, Canada.ORCID https://orcid.org/0000-0002-3228-308X
Brian Lithgow *Biomedical Engineering Program, Faculty of Engineering, University of Manitoba, Winnipeg, MB, Canada.ORCID https://orcid.org/0000-0002-4631-9485
Mohammad Jafari-Jozani *Department of Statistics & Biomedical Engineering, Faculty of Science, University of Manitoba, Winnipeg, MB, Canada.ORCID https://orcid.org/0000-0002-2147-6337
Xikui Wang *Warren Center for Actuarial Studies and Research, The Asper School of Business, University of Manitoba, Winnipeg, MB, Canada.ORCID https://orcid.org/0000-0002-4157-396X
University of Manitoba · CAEpworth Hospital · AUMcGill University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany clinical trials investigating treatment efficacy require an interim analysis. Recently we have been running a large, multisite, randomized, placebo-controlled, double-blind clinical trial investigating the effect of repetitive transcranial magnetic stimulation (rTMS) treatment for improving or stabilizing the cognition of patients diagnosed with Alzheimer disease.

objectiveThe objectives of this paper are to report on recruitment, adherence, and adverse events (AEs) to date, and to describe in detail the protocol for interim analysis of the clinical trial data. The protocol will investigate whether the trial is likely to reach its objectives if continued to the planned maximum sample size.

methodsThe specific requirements of the analytic protocol are to (1) ensure the double-blind nature of the data while doing the analysis, (2) estimate the predictive probabilities of success (PPoSs), (3) estimate the numbers needed to treat, (4) re-estimate the initial required sample size. The initial estimate of sample size was 208. The interim analysis will be based on 150 patients who will be enrolled in the study and finish at least 8 weeks of the study. Our protocol for interim analysis, at the very first stage, is to determine the response rate for each participant to the treatment (either sham or active), while ensuring the double-blind nature of the data. The blinded data will be analyzed by a statistician to investigate the treatment efficacy. We will use Bayesian PPoS to predict the success rate and determine whether the study should continue.

resultsThe enrollment has been slowed significantly due to the COVID-19 pandemic and lockdown. Nevertheless, so far 133 participants have been enrolled, while 22 of these have been withdrawn or dropped out for various reasons. In general, rTMS has been found tolerable with no serious AE. Only 2 patients dropped out of the study due to their intolerability to rTMS pulses.

conclusionsOverall, the study with the same protocol is going as expected with no serious AE or any major protocol deviation.

trial registrationClinicalTrials.gov NCT02908815; https://clinicaltrials.gov/ct2/show/NCT02908815. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31183.

Indexed as

Alzheimer diseasedouble blindinterim analysis, treatment efficacy, repetitive transcranial magnetic stimulationplacebo controlledrandomizedtreatment

Identifiers

PMID34383681
PMCPMC8386362
OpenAlexW3177383691

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.