Protocol for a living systematic review of randomised controlled trials on the clinical efficacy of transcranial pulse stimulation in neurological and psychiatric conditions

Journal article

Introduction: Transcranial pulse stimulation (TPS) is a novel technology with therapeutic promise for Alzheimer’s disease. Given its novelty and the rapidly evolving research in neurology and mental health using this technology, large randomised controlled trials are expected. Therefore, an independent and up-to-date synthesis of the available evidence is needed. In our effort to create a living systematic review of the clinical efficacy of TPS across various conditions, we aim to describe its methodology to ensure its transparency and scientific rigour. This protocol details the predefined methods related to search frequencies, updates to the review and quantitative synthesis. Methods and analysis: We will only include randomised controlled trials involving clinically diagnosed populations and comparing active TPS to sham TPS. We will search MEDLINE, CENTRAL and Web of Science, as well as trial registries and grey literature. The principal searches in databases and trial registries will be rerun monthly, and new evidence will be integrated. Study selection, data extraction and risk-of-bias assessments will be performed independently and in duplicate. All relevant clinical outcomes measured with validated psychometric scales and tests will be collected. The relevance of a quantitative synthesis, the studies to be included in pairwise meta-analysis, appropriate scales, questionnaires and time points will be discussed by the research team annually. If a meta-analysis is conducted, we will use the standardised mean difference as the measure of effect size. We will assess our confidence in the cumulative evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Ethics and dissemination: For this systematic review and meta-analysis, we will collect existing data without generating new datasets. Therefore, ethics approval or consent to participate is not required. We will publish our initial systematic review when a total of four randomised controlled trials across different health conditions using active TPS compared with sham TPS are available. At this stage of our project, we anticipate updating the living systematic review annually following the publication of the baseline review. We will conclude the living phase of the review when high certainty of evidence is achieved or if the topic loses its relevance. Systematic review registration: CRD42024595947.

Authors: Demina, A; Casey, D; Amaral, S; Fabus, MS; Béjot, Y

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BMJ Publishing Group
• Journal: BMJ Open
• Volume: 16
• Issue: 5
• Pages: e117329
• Article number: bmjopen-2026-117329
• Publication date: 2026-05-21
• Acceptance date: 2026-04-15
• DOI: 10.1136/bmjopen-2026-117329
• EISSN: 2044-6055
• ISSN: 2044-6055
• Language: English
• Keywords: NEUROLOGY; Systematic Review; MENTAL HEALTH