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Repeated Transcranial Magnetic Stimulation for Improving Cognition in Alzheimer Disease: Protocol for an Interim Analysis of a Randomized Controlled Trial
Moussavi Z, Koski L, Fitzgerald PB, Millikin C, Lithgow B, Jafari-Jozani M, Wang X.. JMIR research protocols, 2021-08-09
Topic: Amyloid, tau and blood-test diagnosis
Background Many 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. Objective The 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. Methods The 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. Results The 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 Nevertheless, so far 133 participants have been enrolled, while 22 of these have been withdrawn or dropped out for various reasons.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. Conclusions Overall, the study with the same protocol is going as expected with no serious AE or any major protocol deviation. Trial registration ClinicalTrials.gov NCT02908815; https://clinicaltrials.gov/ct2/show/NCT02908815. International registered report identifier (irrid) DERR1-10.2196/31183.
Key findings
- Results The enrollment has been slowed significantly due to the COVID-19 pandemic and lockdown.
- Conclusions Overall, the study with the same protocol is going as expected with no serious AE or any major protocol deviation.
Why it matters
This is a protocol paper describing how an ongoing randomized trial of repetitive transcranial magnetic stimulation will be analyzed partway through, so it does not yet report whether the treatment works. Enrollment has been slowed by the COVID-19 pandemic, and no serious adverse events or major protocol deviations have occurred so far.
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Study details
- Participants150
- Evidence strengthHigh
How this study scored 43/100
Published in a peer-reviewed journal. Scored zero for study design and effect reported because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (JMIR research protocols) |
| Journal's citation record | 0 / 4 | JMIR Research Protocols: journal h-index 62 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 3 / 5 | 2021 — within 6 year(s) of the newest study here |
| Sample size | 2 / 4 | 150 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 1 / 2 | Randomised (as stated in the record) |
| Times cited | 2 / 7 | Cited 7 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 1.0 citations a year over 7 year(s) since 2021 |
| Impact for its field and year | 1 / 6 | Cited 0.4× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 5 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 1 / 4 | Last-listed author Xikui Wang: h-index 12 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | McGill University: institution h-index 1,373 (OpenAlex) |
| Multi-centre collaboration | 1 / 3 | OpenAlex lists 3 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 34383681) |
| Free to read | 2 / 2 | Free to read |
| Total | 43 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
APA 7th
Moussavi, Z., Koski, L., Fitzgerald, P. B., Millikin, C., Lithgow, B., Jafari-Jozani, M., et al. (2021). Repeated Transcranial Magnetic Stimulation for Improving Cognition in Alzheimer Disease: Protocol for an Interim Analysis of a Randomized Controlled Trial. JMIR research protocols. https://doi.org/10.2196/31183
Vancouver
Moussavi Z, Koski L, Fitzgerald PB, Millikin C, Lithgow B, Jafari-Jozani M, et al. Repeated Transcranial Magnetic Stimulation for Improving Cognition in Alzheimer Disease: Protocol for an Interim Analysis of a Randomized Controlled Trial. JMIR research protocols. 2021. doi:10.2196/31183. PMID: 34383681.
BibTeX
@article{moussavi2021-34383681,
author = {Moussavi, Z. and Koski, L. and Fitzgerald, P. B. and Millikin, C. and Lithgow, B. and Jafari-Jozani, M. and Wang, X.},
title = {{Repeated Transcranial Magnetic Stimulation for Improving Cognition in Alzheimer Disease: Protocol for an Interim Analysis of a Randomized Controlled Trial}},
journal = {JMIR research protocols},
year = {2021},
doi = {10.2196/31183},
pmid = {34383681},
url = {https://doi.org/10.2196/31183}
}
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