Protocol for adjunctive PC6 magnetic stimulation with rTMS in post-stroke cognitive impairment patients
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Key Takeaway
Note that this is a protocol with no results or safety data available for clinical decision-making.
This document describes a randomized controlled trial protocol focusing on patients with post-stroke cognitive impairment (PSCI). The study plans to enroll 105 participants to evaluate the effects of an intervention involving adjunctive PC6 magnetic stimulation combined with repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC). The comparator groups will receive either PC6 acupuncture or sham magnetic stimulation with rTMS over the left DLPFC. The setting and specific study phase are not reported in this protocol.
The primary outcome measure is the change in Montreal Cognitive Assessment (MoCA) scores from baseline to week 3. Secondary outcomes include the Mini-Mental State Examination (MMSE), Modified Barthel Index (MBI), Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD), Pittsburgh Sleep Quality Index (PSQI), fMRI data, fNIRS data, and adverse events. The planned follow-up period is 3 weeks.
Safety and tolerability data are not reported because the study has not yet been conducted; adverse events, serious adverse events, discontinuations, and general tolerability remain unknown. Key limitations include the absence of results, safety data, and funding information. Because this is a protocol, no conclusions regarding efficacy or causality can be drawn at this time.
Clinical relevance cannot be determined from this document as no results are available. Practitioners should await the publication of final study results before considering this intervention for PSCI management. The protocol serves as a plan for future research rather than current evidence for practice.
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View Original Abstract ↓
BackgroundPost-stroke cognitive impairment (PSCI) is a common stroke complication, significantly reducing patients’ quality of life and increasing caregiving burden. Repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) improves cognition but with limited efficacy. Stimulation of Neiguan (PC6), a key acupoint in traditional Chinese medicine, modulates cognition-related brain networks.ObjectiveTo compare cognitive improvement and brain network remodeling in PSCI patients who receive rTMS over the L-DLPFC combined with (1) PC6 magnetic stimulation (MAG), (2) PC6 acupuncture (ACU), or (3) PC6 sham magnetic stimulation (SHM).MethodsThis three-arm randomized controlled trial will enroll 105 patients with PSCI, randomly allocated 1:1:1 to the MAG (n = 35), ACU (n = 35), and SHM (n = 35) groups. Interventions will be administered 5 times/week for 3 weeks. All groups will receive high-frequency rTMS over the L-DLPFC (10 Hz, 80% rest motor threshold). The primary outcome is the Montreal Cognitive Assessment (MoCA) change from baseline to week 3. Secondary outcomes include the Mini-Mental State Examination (MMSE), Modified Barthel Index (MBI), Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD), Pittsburgh Sleep Quality Index (PSQI), and adverse events. Functional magnetic resonance imaging (fMRI) and functional near-infrared spectroscopy (fNIRS) data will be acquired at baseline and post 3-week treatment. Clinical data will be analyzed via SPSS 26.0 using repeated measures analysis of variance (ANOVA) to compare intergroup changes in outcomes across time points. Neuroimaging data will be processed in MATLAB R2018a. Correlation analyses will assess associations between clinical scores and neuroimaging parameters.ConclusionThis study will provide the first randomized controlled evidence for acupoint magnetic stimulation in PSCI, demonstrating that adding MAG to L-DLPFC rTMS confers additional cognitive benefits. Its mechanism in reshaping brain networks will be elucidated via fNIRS-fMRI, which is expected to accelerate clinical translation of non-pharmacological interventions.Clinical trial registrationhttps://www.chictr.org.cn/, identifier ChiCTR2400090768.
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