Biobanking, digital health and privacy: the choices of 1410 volunteers and neurological patients regarding limitations on use of data and biological samples, return of results and sharing.

BACKGROUND: The growing diffusion of artificial intelligence, data science and digital health has highlighted the role of collection of data and biological samples, thus raising legal and ethical concerns regarding its use and dissemination. Further, the expansion of biobanking, from the basic collection of frozen specimens to the virtual biobanks of specimens and associated data that exist today, has given a revolutionary potential on healthcare systems, particularly in the field of neurological diseases, due to the inaccessibility of central nervous system and the need of non-invasive investigation approaches. Informed Consent (IC) is considered mandatory in all research studies and specimen collections, and must specifically take into account the ethical respect to the individuals to whom the used biological material and data belong. METHODS: We evaluated the attitudes of patients with neurological diseases (NP) and healthy volunteers (HV) towards the donation of biological samples to a biobank for future research studies on neurological diseases, and limitations on the use of data, related to the requirements set by the General Data Protection Regulation (GDPR). The study involved a total of 1454 subjects, including 502 HVs and 952 NPs, recruited at Santa Lucia Foundation IRCCS, Rome, from 2020 to 2024. RESULTS: We found that (i) almost all subjects agreed with the participation in biobanking (ii) and authorization to genetic studies (HV = 99.1%; NP = 98.3%); Regarding the return of results, (iii) we found a statistically significant difference between NP and HV, the latter preferring not to be informed of potential results (HV = 43%; NP = 11.3%; p < 0.0001); (iv) a small number limited the sharing inside European Union (EU) (HV = 4.6%; NP = 6.6%), whereas patients were more likely to refuse transfer outside EU (HV = 7.4%; NP = 10.7% p = 0.05); (v) nearly all patients agreed with the use of additional health data from EMR for research purposes (98.9%). CONCLUSIONS: Consent for the donation of material for research purposes is crucial for biobanking and biomedical research studies that use biological material of human origin. Here, we have shown that choices regarding participation in a neurological biobank can be different between HVs and NPs, even if the benefit for research and scientific progress is recognized. NP have a strong interest in being informed of possible results but limit sharing of samples, highlighting a perception of greater individual or relative benefit, while HV prefer a wide dissemination and sharing of data but not to have the return of the results, favoring a possible benefit for society and knowledge. The results underline the need to carefully manage biological material and data collected in biobanks, in compliance with the GDPR and the specific requests of donors.

Late recovery of responsiveness after intra-thecal baclofen pump implantation and the role of diffuse pain and severe spasticity: a case report.

Patients with a prolonged disorder of consciousness (DoC) may present with severe spasticity and diffuse pain, which might impair motor output, thus preventing any possible behavioral responsiveness. A 26-year-old man affected by frontoparietal hemorrhage was operated by hematoma evacuation and decompressive craniectomy; coma persisted for 1 month; cranioplasty and ventriculo-peritoneal shunting was performed after 4 months. At admission in rehabilitation, he was diagnosed as vegetative state/unresponsive wakefulness syndrome (VS/UWS). The implantation of intrathecal baclofen (ITB) pump (Medtronic SynchroMed™ II), 14 months after, (60 µg/daily), dramatically improved behavioral responsiveness according to Coma Recovery Scale-Revised (CRS-R) from 6 to 12 (1 month after ITB). Nociception Coma Scale-Revised (NCS-R) also changed from 4 to 8 at the same time points. This case report may be an example of covert cognition that should have been diagnosed as a functional locked-in syndrome or motor-cognitive dissociation, rather than as VS/UWS.

Improvement rate of patients with severe brain injury during post-acute intensive rehabilitation.

Patients with severe acquired brain injury (SABI) may evolve towards different outcomes. The primary aim was to evaluate the clinical evolution of a large population of patients with SABI admitted to post-acute rehabilitation from 2001 to 2016, diagnosed with severe brain injury (GCS ≤ 8) in the acute phase and a coma duration of at least 24 h. The possible changes between the admission time to a post-acute rehabilitation hospital and the discharge time were measured by means of Glasgow Outcome Scale (GOS), Level of Cognitive Functioning (LCF), and Disability Rating Scale (DRS). We also correlated the improvement rate with some sociodemographic and clinical features of the individuals with SABI enrolled. Data of 890 patients were analyzed (54% TBI, length of stay = 162 ± 186 days, GCS = 7.46 ± 1.28); time interval from the SABI (OR = 0.246, CI 95% = 0.181 - 0.333), scores at admission of LCF (OR = 2.243, CI 95% = 1.492 - 3.73), GOS (OR = 0.138, CI 95% = 0.071 - 0.266), DRS (OR = 0.457, CI 95% = 0.330 - 0.632), and etiology (OR = 2.273, CI 95% = 1.676 - 3.084) played a significant role (p < 0.001, explained variance 69.9%) for improving GOS score. Time interval from the SABI to admission in our post-acute rehabilitation ward (OR = 0.300, CI 95% = 0.179 - 0.501, p < 0.001), length of rehabilitation stay (OR = 2.808, CI 95% = 1.694 - 4.653, p < 0.001), and etiology (OR = 1.769, CI 95% = 1.095 - 2.857, p = 0.020) led to a statistically significant improvement in DRS (explained variance 91%). The most significant predictive factors for the outcome of patients with SABI were etiology, time interval from SABI to admission in rehabilitation, and length of rehabilitation stay.

Quantitative EEG patterns following unilateral stroke: a study in chronic stage.

The aim of this study was to investigate the EEG power spectra obtained during rest and mental processing in chronic stroke patients. Seventeen patients with stabilized unilateral cerebral ischemia, grouped according to the side of lesion, underwent quantitative EEG recordings during rest and attentive/cognitive tasks. EEG spectral values were compared with those of 11 healthy subjects. Patients displayed different EEG patterns from controls, under rest condition: patients with left hemispheric lesion were characterized by a preserved alpha and beta band "reactivity," with a lack of significant changes in slow band components. In patients with right hemisphere lesion, no significant changes of the slow and fast band activities were evident during each task. These findings indicate that different EEG patterns of activation characterize stroke patients with left and right hemispheric damage.