Methodology:
This is a prospective, controlled, randomised, open-label, single-centre, two-arm, parallel, 1:1 ratio, non-drug therapeutic interventional study with three months of follow-up (Category 2)
The analysis of the primary and secondary endpoints will be conducted on an intention-to-treat (ITT) basis: each patient will be analysed in his or her randomisation arm once the patient has been assessed at inclusion and has received at least one assessment of the primary endpoint.
Initial comparability of groups A description of each group will be made by giving the frequencies of the different categories for the qualitative variables. As the distributions of the quantitative variables are not always Gaussian, the description of these variables will be done using the mean and the standard deviation but also the median and the minimum and maximum values. In case of non-comparability of the groups on one of the confounding factors, an adjustment or a stratification (in case of interaction) will be considered.
Analysis of primary endpoint The absolute change in the SF36 total score between the 2 assessments (T0 and T3 months) will be compared between the two groups using a Student's t test if the distribution is Gaussian or by a non-parametric test otherwise (Mann-Witney).
To estimate the "effect size", the variation of the score will be analysed by an analysis of covariance model including the intervention effect (ETP) and the SF36 inclusion value. In case of a non-Gaussian distribution, a transformation for normalisation will be applied and the normality of the residuals will be tested.
Analysis of secondary endpoints Changes in the SF36 score, SF36 subscores, anxiety and depression symptom scores and EVIBE will be analysed using the same methods as the primary endpoint.
Changes in knowledge of the disease will be analysed for each domain (Chi-2 test or Fisher's exact test) in intergroup and intragroup (Mac-Nemar's chi2) at 1 and 3 months.
Depending on the nominal, ordinal or continuous nature of the other clinical and socio-demographic variables, the analysis is carried out using Pearson's, Spearman's or Kendall's correlation coefficients, using a Chi-square test or Fisher's exact test, or using parametric (Student's or ANOVA) or non-parametric (Mann Whitney's and Kruskall Wallis' test) tests of comparison of means.
The alpha risk will be set at 5% for all tests. The statistical analysis will be carried out at the clinical research unit of the Department of Medical Information of the Montpellier CHRU with SAS version 9 software (SAS Institute, Cary, N.C.).
Number of patients:
The calculation of the number of subjects was carried out in collaboration with the Clinical and Epidemiological Research Unit of the University Hospital of Montpellier.
Based on the study \[5\] available in this field and using the SF36, the investigators hypothesise that the difference in variation of the total quality of life score (primary endpoint) to be highlighted between the 2 groups would be of the order of 10 points, with a standard deviation of 13. With a power of 80% and a first order risk of 5%, 27 subjects per group would be required. Anticipating a 10% drop-out rate, the number of patients to be recruited is 30 subjects in each arm, or 60 subjects in total.
Patient selection:
The patients likely to be included in the study are adults, followed in the functional neurosurgery department, associated with the "resistant brain pathology" unit, operated, treated by Continuous Electrical Neuromodulation, and medically stabilized.
Duration of project:
Duration of the inclusion period: 24 months Duration of participation of each participant: 3 months Duration of statistical analysis and final report writing: 7 months Expected duration of the study: 34 months
Schedule visit:
During a follow-up hospitalisation in the unit, patients will be systematically informed about the music therapy protocol. If the patients meet the inclusion criteria and agree to participate in our research, after signing the consent form with the study doctor, the patients will be called for an inclusion visit (V0). During this V0 visit, the patients will be received by the music therapist in order to carry out a psychomusical assessment of about 1 hour, then by the neuropsychologist to submit them to the various evaluations mentioned below.
Patients will then be randomised to one of two groups : "intervention" group or "control" group.
The music therapy programme will consist of 14 sessions spread over three months, with two weekly sessions in the first month, a single weekly session in the following month and two monthly sessions in the last month. Given the pilot nature of our study, the investigators will carry out an evaluation at 1 month (V1) in order to observe the impact of the protocol proposed intensively in the first month. A final evaluation will be proposed by the neuropsychologist at the end of the study. This will be coupled with a routine medical visit in the unit (V2).
