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AI-DBS study: protocol for a longitudinal prospective observational cohort study of patients with Parkinsons disease for the development of neuronal fingerprints using artificial intelligence

Por: Stam · M. J. · de Neeling · M. G. J. · Keulen · B. J. · Hubers · D. · de Bie · R. M. A. · Schuurman · R. · Buijink · A. W. G. · van Wijk · B. C. M. · Beudel · M.
Introduction

Deep brain stimulation (DBS) is a proven effective treatment for Parkinson’s disease (PD). However, titrating DBS stimulation parameters is a labourious process and requires frequent hospital visits. Additionally, its current application uses continuous high-frequency stimulation at a constant intensity, which may reduce efficacy and cause side effects. The objective of the AI-DBS study is to identify patient-specific patterns of neuronal activity that are associated with the severity of motor symptoms of PD. This information is essential for the development of advanced responsive stimulation algorithms, which may improve the efficacy of DBS.

Methods and analysis

This longitudinal prospective observational cohort study will enrol 100 patients with PD who are bilaterally implanted with a sensing-enabled DBS system (Percept PC, Medtronic) in the subthalamic nucleus as part of standard clinical care. Local neuronal activity, specifically local field potential (LFP) signals, will be recorded during the first 6 months after DBS implantation. Correlations will be tested between spectral features of LFP data and symptom severity, which will be assessed using (1) inertial sensor data from a wearable smartwatch, (2) clinical rating scales and (3) patient diaries and analysed using conventional descriptive statistics and artificial intelligence algorithms. The primary objective is to identify patient-specific profiles of neuronal activity that are associated with the presence and severity of motor symptoms, forming a ‘neuronal fingerprint’.

Ethics and dissemination

Ethical approval was granted by the local ethics committee of the Amsterdam UMC (registration number 2022.0368). Study findings will be disseminated through scientific journals and presented at national and international conferences.

Protocol for an observational study to assess the impact of pharmacogenetics on outcomes in vascular surgery (PROSPER)

Por: Burke · K. A. · Mirza · S. · Wright · S. · Greaves · N. S. · Newman · W. G. · McDermott · J. H.
Introduction

Patients with chronic limb-threatening ischaemia (CLTI) are often prescribed clopidogrel in order to reduce their risk of major adverse limb and cardiovascular events. Clopidogrel is metabolised by the CYP2C19 enzyme and genetic variations in CYP2C19 are common. These variants can influence an individual’s ability to metabolise clopidogrel to its active metabolite. Few studies have investigated the relationship between patient genotype and outcomes in vascular surgery. This work aims to establish the relationship between patient genotype and outcomes after revascularisation in patients with CLTI who are prescribed clopidogrel. It will consider whether pharmacogenetics can be used to ensure patients are prescribed effective medications to optimise their outcomes.

Methods and analysis

This is an observational cohort study of patients undergoing lower limb surgical, endovascular or hybrid revascularisation for CLTI at Manchester University NHS Foundation Trust. Patients taking clopidogrel post-procedure, as well as those prescribed a non-clopidogrel based medication regimen, will be recruited prior to or shortly after revascularisation. Patients will undergo CYP2C19 genotyping and will be followed up using online records. The study has 90% power to detect 114 amputations with a target sample size of 483 participants. The primary outcomes are risk of amputation at 1 year and a composite endpoint for the risk of major adverse limb events (MALE) or death from any cause at 1 year. Secondary outcomes are risk of MALE at 1 year, risk of major adverse cardiovascular events (MACE) or death from any cause at 1 year, death within 30 days of revascularisation, minor re-interventions at 1 year, total number of re-interventions at 1 year and rate of systemic or gastrointestinal bleed at 1 year.

Risk of amputation, MALE and MACE will be analysed using Cox models. All remaining outcomes will be analysed using negative binomial models. Potential competing events for the risk of amputation will be investigated as part of a sensitivity analysis. Patients given a non-clopidogrel-based medication will be compared as an additional analysis.

Ethics and dissemination

Manchester University Research Ethics Committee approval obtained as part of the Implementing Pharmacogenetics to Improve Prescribing (IPTIP) trial process (IRAS 305751). The results of the study will be published in a peer-reviewed journal and presented at international conferences.

Registration

This work is a sub-protocol for the IPTIP study which is registered as ISRCTN14050335.

Impact of hypersexuality on spousal carers of patients with Parkinsons disease and frontotemporal dementia: a qualitative study

Por: Tayim · N. · Panicker · J. · Foley · J. · Selai · C. · El Sheikh · W. G.
Objectives

Hypersexuality involves an inability to control intense, recurring sexual impulses, resulting in repetitive sexual behaviours. It frequently manifests in patients with neurodegenerative disorders such as Parkinson’s disease (PD) and dementia. Using a qualitative approach, this study aims to explore the impact of hypersexuality on spousal carers of patients with PD and dementia.

Design

Qualitative study using semistructured interviews and thematic analysis.

Setting

This study was conducted in secondary care settings, including movement disorder and dementia clinics, as well as through patient support organisations. Participants were recruited from multiple centres across the UK. Interviews were conducted in a clinical research setting.

Participants

Eight spousal carers (five caring for patients with PD, three for patients with dementia) participated in the study. Participants were selected based on their role as primary carers and their experience managing hypersexuality in their partners.

Results

The thematic analysis identified 12 themes: manifestations, sexual practices, impact, control, emotional formulations, beliefs in causes of hypersexuality and attributions, relationship with the partner, dealing with hypersexuality, coping with hypersexuality, self-image, stigma and professional help-seeking. Hypersexuality altered patients’ sexual cognitions and behaviours, causing distress and strain on carers’ mental health and marital life. Carers struggled to cope with their partners’ hypersexuality, facing emotional burden and barriers to seeking professional help.

Conclusions

Hypersexuality significantly impacts spousal carers of patients with PD and dementia, affecting their emotional well-being and relationships. Healthcare professionals should recognise and address hypersexuality’s psychological and relational consequences. Psychoeducation, support groups and tailored interventions for patients and carers are recommended to alleviate emotional distress. Future research should explore the broader familial impact of hypersexuality and develop effective management strategies.

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