Description of work
T6.1 Obtain ethical approvals for clinical study in human subjects (SHEBA, MDA Hellas, AUTH) [M1-M4]
MAMEM researchers in each clinical centre will obtain Ethical approval, from their respective institutional Ethics Committee. The clinical partners will formulate a consistent protocol across the centres, and in the process will take into account any inconsistencies among the rules and regulations between the countries (if any exist) and will come up with a unified protocol. Each party will be responsible for accurate translation to the local language. The ethical strategy that will be adopted in MAMEM in discussed in detail in Section 5.
T6.2 Clinical requirements definition and usage scenarios specification (SHEBA, MDA Hellas, AUTH) [M1-M7]
We will conduct three focus groups of six health professionals in each from different disciplines (Medical doctors, occupational therapists, physiotherapists, nurses, social workers and psychologists) – We will conduct qualitative analysis of the focus groups transcripts. In parallel, we will formulate questionnaires for patients, for care givers and for relatives (e.g., spouses) in which we will identify the current habits and difficulties, involved in computer operation, and the desired goals for improvement. The outcomes of this task will be disease specific end user usage scenarios of the platform in terms of: a) detailed profile of their disabilities, and how these disabilities prevent them from using a computer interface; and b) the subjects’ willingness and motivation to perform multimedia related tasks using MAMEM and ways to increase this willingness. An additional outcome of this stage will be the definition of the clinical profile of the eligible users of MAMEM. e.g., subjects who have involuntary eye movements, or who have undergone procedures that may affect EEG signals (e.g., implanted stimulating electrodes in subjects with Parkinson’s disease), will be considered as subjects with counter indications.
T6.3 Define and perform experimental protocols of pilot trials with patients (SHEBA, MDA Hellas, AUTH, CERTH, UNI KO-LD) [M8-M23, M28-M34]
In the first stage of this task, we will define experimental protocols to demonstrate the ability of the MAMEM platform to become operational through the users’ eyes and mind. In each clinical site, we will define an experimental protocol specific to the tested patient cohort, which includes definitions of participant’s inclusion and exclusion criteria. We intend to include about 21 subjects in each of the clinical site (see below for time course of recruitment) from each patient group from both genders and in all ages (as relevant to the specific disease, i.e., subjects with Parkinson’s disease are typically older, while spinal cord injuries can occur in all range ages), as well as from an age- and gender-matched healthy group. We will define the experimental set up (adaptations may be needed based on the requirements of a specific target group), and the experimental procedure. The latter includes (1) introduction to the platform; (2) training of users; (3) testing the ability to perform dictated tasks. These tasks will include basic computer operations, starting with moving the mouse cursor, advancing to opening windows, saving files and finally to the more advanced usage scenarios for multimedia management and authoring (cf. Section 1.1.2), including image/video/audio management, image/video/audio editing, image/video/audio authoring and generation of a multimedia presentation (e.g. a slide show). Finally, we will define the following outcome measures: (1) the existence of impasses or hardships in operation of the platform by the patients in any of the stages of the procedure; (2) learning curves based on response errors, reaction times, during the procedure phase of training and then during the ability to perform dictated tasks phase; (3) user satisfaction; (4) care givers and therapist satisfaction. Additionally, we will draw the exact strategy on data security in collecting and storing personal data (e.g., through the use of the INFOR10[1]) to comply with legal and ethical regulations (cf. Section 5). Finally we will define the statistical tools to obtain the results and draw the conclusions. The second stage of this task will be to perform the protocols defined in the first stage. This will be done in clinical sites, each participant will be invited to spend about half a day of practical experimentations in which he/she will be trained and tested in several sessions (the length of the sessions and the number of sessions will be individualized to the subjects, based on their fatigue, compliance etc.). If needed the subject will be invited for a second visit to complete the protocol. The main obstacle which we anticipate is certain frustration and impatience among subjects that will find it hard to employ the new brain-computer interaction paradigm. We intend to first test 11 subjects. From this eleven subjects group, six will be healthy subjects (3 women, 3 man) in age range similar to the age of the particular patient group tested in the particular site (e.g., most likely ages between 50-80 years in the site involving Parkinson’s disease subjects). We will first test the MAMEM platform on the healthy subjects, and then on additional 5 patients. After testing this group of eleven subjects, we will perform interim assessments re-define the experiments as needed and carry a second round of experiments with additional 10 subjects – all of them belonging to the same patient cohort. In summary, in this task we will study 18 healthy subjects and 45 subjects with diseases that impose severe limitation on their ability to manipulate computer mouse and keyboard. For assuring system usability prior to testing the system with patient’s cohort, six healthy subjects will be tested. To evaluate the rate of successful use by patients we intend to quantify, for example, the rate of response errors for multiple dictated tasks such as reaching spots on the computer screen with the mouse cursor. We anticipate that in these trials we will obtain 75-85% success rate (c.f., Obj.3), as opposed to 50% in random cursor ‘cursing’ tasks. The entire process will be reviewed on annual basis by an internal ethical advisor to ensure that all procedures meet the ethic rules approved by the ethical committees (c.f. D6.3).
Task 6.4 Conduct data analysis from pilot experiments (AUTH, SHEBA, MDA Hellas) [M24-M36]
The assessment of the results from the pilot trials will start immediately after the completion of the protocols. Any aspect of the protocol will be evaluated based on the results for each of the three clinical sites. The results of the pilot experimental protocols will be analyzed in ongoing rolling basis, upon completion of each of experiments in each of the sites. We will use statistical tools such as descriptive statistics, regression analysis, in order to quantify the performance of the subjects in terms of learning rate, response error rates, reaction times etc. Similarly, the scores of the questionnaires will be evaluated. The outcome of this task will be reported on the experiments and results, in particular the feasibility of the platform, usability of the interface and effectiveness in performing a certain task. Based on this, we will be able to prepare practical conclusions for performing WP7, for example paradigm usage training protocols. We will re-apply for ethical approvals, in case of modifications in the protocols.
[1] http://www.infor.com/company/news/pressroom/pressreleases/Infor10/