ArticleTrials2022
mPFC-rTMS for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
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.
Who cites it
1 citing paper in PubMed, 3 citations in OpenAlex.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInsomnia is the most common sleep disorder. Repetitive transcranial magnetic stimulation (rTMS) is safe and effective for insomnia disorder (ID). Convergent evidence show that the medial prefrontal cortex (mPFC) may be involved in the regulation of sleep and awakening at the cortical level and may serve as a potential target of rTMS in the treatment of ID. The purpose of this clinical trial is to study the efficacy of mPFC-rTMS in the treatment ID and explore the neural mechanism using resting-state functional magnetic resonance imaging (fMRI). METHODS AND
designThis will be a parallel-group randomized, patient- and assessor-blinded trial. The study will recruit 60 ID patients assigned to a real mPFC-rTMS group or a sham mPFC-rTMS group. The allocation ratio is 1:1, with 30 subjects in each group. Interventions will be administered five times per week over a 4-week period, with an 8-week follow-up period. All participants will undergo neuropsychological and fMRI evaluations. The primary outcome measure of this study is the change scores of the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome measures include the fMRI measurements, the Hamilton Depression Scale (HAMD), the Hamilton Anxiety Scale (HAMA), a sleep diary, and a polysomnography. Assessment of all parameters will be performed at baseline, post-treatment, and during follow-up. DISCUSSION: It is expected that the study results will provide strong evidence of the effectiveness and the neural mechanism by which mPFC-rTMS improves sleep quality in ID patients.
trial registrationChinese Clinical Trials Register ChiCTR2100054154. Registered on 10 December 2021.
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