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Methodological Recommendations for Studies on the Daily Life Implementation of Implantable
Mariska J Vansteensel1, Mariana P Branco1, Sacha Leinders1
1UMC Utrecht Brain Center, Department of Neurology and Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands.
Neurorehabilitation and Neural Repair
|September 20, 2022
Summary
Implantable brain-computer interfaces (BCIs) offer communication restoration for locked-in syndrome (LIS). This guide provides recommendations for future clinical studies on daily life BCI implementation.
Area of Science:
- Neuroscience and Biomedical Engineering
- Assistive Technology Research
Background:
- Implantable brain-computer interfaces (BCIs) show promise for restoring communication in individuals with locked-in syndrome (LIS).
- A fully implantable BCI system using electrocorticography (ECoG) electrodes and a subcutaneous amplifier was previously developed, enabling communication for an LIS individual.
Purpose of the Study:
- To provide an overview of procedures and recommendations for future clinical studies on daily life implementation of implantable communication-BCIs.
- To inform the BCI research community and contribute to methodological standardization in implantable BCI research.
Main Methods:
- Review of relevant literature and the authors' own experiences.
- Development of recommendations covering participant recruitment, screening, inclusion, imaging, hospital admission, implantation, training, and support.
- Focus on studies involving daily life implementation of implantable communication-BCIs for individuals with LIS.
Main Results:
- Identification of key procedures and recommendations for conducting clinical studies on implantable communication-BCIs.
- Highlighting the need for further validation in daily life settings and improvements in communication speed.
Conclusions:
- Experience gained from previous implantable BCI research can benefit the design and execution of future studies.
- Standardized methodologies are crucial for advancing the clinical implementation of implantable communication-BCIs for LIS patients.
