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Simulated Electroconvulsive Therapy: A Novel Approach to a Control Group in Clinical Trials
McManus KR, Lapid MI, Forester BP, Mueller M, Hermida AP, Nykamp L, Harper DG, Seiner SJ et al.. The journal of ECT, 2022-03-01
Topic: Risk, prevention and care in population studies
Objectives Agitation is the most common behavioral symptom of Alzheimer disease (AD) affecting approximately 40% to 60% of the AD population, yet there are no Food and Drug Administration-approved therapies for the myriad of behavioral or psychological symptoms of dementia. There is growing evidence from naturalistic studies that electroconvulsive therapy (ECT) is a safe and effective treatment for agitation in AD patients who are refractory to pharmacotherapy and behavioral interventions. Despite the existing evidence, ECT remains underused because of stigma, lack of education, and concerns regarding adverse cognitive effects. Randomized controlled clinical trials of ECT are an opportunity to provide high-quality evidence of ECT as a safe and efficacious treatment for agitation in the AD population. We describe the methods for the Electroconvulsive Therapy in Alzheimer's Dementia study, which uses a novel, simulated ECT (S-ECT) control group to conduct a single-blind efficacy study of ECT for the treatment of agitation and aggression in individuals with moderate to severe AD. Methods We discuss the rationale, study design, methodology, ethical and practical challenges, and management strategies in using an S-ECT group as the comparator arm in this randomized controlled trial of ECT in AD-related treatment refractory agitation and aggression. Conclusions Validation of the safety and efficacy of ECT in patients with advanced AD with refractory agitation and aggression is necessary. This can be accomplished through creative formulation of S-ECT groups that effectively maintain the blind while providing scientific integrity.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
McManus, K. R., Lapid, M. I., Forester, B. P., Mueller, M., Hermida, A. P., Nykamp, L., et al. (2022). Simulated Electroconvulsive Therapy: A Novel Approach to a Control Group in Clinical Trials. The journal of ECT. https://doi.org/10.1097/yct.0000000000000832
Vancouver
McManus KR, Lapid MI, Forester BP, Mueller M, Hermida AP, Nykamp L, et al. Simulated Electroconvulsive Therapy: A Novel Approach to a Control Group in Clinical Trials. The journal of ECT. 2022. doi:10.1097/yct.0000000000000832. PMID: 35220356.
BibTeX
@article{mcmanus2022-35220356,
author = {McManus, K. R. and Lapid, M. I. and Forester, B. P. and Mueller, M. and Hermida, A. P. and Nykamp, L. and Harper, D. G. and Seiner, S. J. and others},
title = {{Simulated Electroconvulsive Therapy: A Novel Approach to a Control Group in Clinical Trials}},
journal = {The journal of ECT},
year = {2022},
doi = {10.1097/yct.0000000000000832},
pmid = {35220356},
url = {https://doi.org/10.1097/yct.0000000000000832}
}
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's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
Key findings
- Randomized controlled clinical trials of ECT are an opportunity to provide high-quality evidence of ECT as a safe and efficacious treatment for agitation in the AD population.
- We describe the methods for the Electroconvulsive Therapy in Alzheimer's Dementia study, which uses a novel, simulated ECT (S-ECT) control group to conduct a single-blind efficacy study of ECT for the treatment of agitation and aggression in individuals with moderate to severe AD.
- Methods We discuss the rationale, study design, methodology, ethical and practical challenges, and management strategies in using an S-ECT group as the comparator arm in this randomized controlled trial of ECT in AD-related treatment refractory agitation and aggression.
- Conclusions Validation of the safety and efficacy of ECT in patients with advanced AD with refractory agitation and aggression is necessary.
- This can be accomplished through creative formulation of S-ECT groups that effectively maintain the blind while providing scientific integrity.
Why it matters
This paper describes the methods for a trial testing electroconvulsive therapy for agitation and aggression in people with moderate to severe Alzheimer's disease, using a simulated control group. It reports no results, so it does not yet show an effect on treating, curing or preventing the disease.
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Study details
- Study designrandomized controlled trial
- Evidence strengthHigh
How this study scored 56/100
Published in a peer-reviewed journal, and it is a randomised controlled trial. Scored zero for sample size and effect reported because the record does not state it. We have no data on senior author's track record, so that was left out: it earned 54 of the 96 points we could judge it on, which is 56 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (The journal of ECT) |
| Journal's citation record | 1 / 4 | Journal of Ect: journal h-index 81 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial |
| 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 | 2022 — within 6 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| 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 (pubmed indexes it as a clinical or observational study) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 2 / 7 | Cited 14 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 2.3 citations a year over 6 year(s) since 2022 |
| Impact for its field and year | 2 / 6 | Cited 2.0× 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 | 0 / 4 | Cited 2 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 3 / 3 | Harvard University: institution h-index 3,235 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 8 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 35220356) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 54 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 54 of the 96 points we could judge it on is 56 out of 100. |
| Total | 56 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
- DOI: 10.1097/yct.0000000000000832
- PubMed: 35220356
- Original source →
- Free full text: PubMed Central →
Full text: free to read — PubMed Central lists this copy as free to read: the link above (checked 10 Oct 2026).
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