Clinical trial NCT05214313: Impact of a Standardized Music Therapy Protocol on the Quality of Life of Patients With Abnormal Movements Treated With Continuous Electrical Neuromodulation
Official title: Impact of a Standardized Music Therapy Protocol on the Quality of Life of Patients With Abnormal Movements Treated With Continuous Electrical Neuromodulation (Music-QOL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dystonia
Parkinson Disease
Essential Tremor
Keywords: Music therapy
Abnormal movements
Quality of life
Functional neurosurgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study of the impact of music on emotional, motor and cognitive aspects remains recent. Music therapy has experienced a major boom over the last half century thanks to neuroradiological techniques for investigating the brain, and in particular in vivo functional MRI. Brain imaging has also made it possible to highlight and analyse certain activations of the networks concerned during the passive listening of music (receptive music therapy) but also during the playing of a musical instrument and/or the use of the voice (active music therapy). The accumulated data in music neurophysiology is now considerable \[1\]. Music therapy has thus been associated with motor rehabilitation in the case of acquired (stroke) and/or degenerative (Parkinson's disease) pathologies and has also been proposed as a means of pain relief. However, although proposed in the middle of the 20th century as a potentially therapeutic tool, music therapy has not managed to prove sufficiently effective to be validated in medicine. One of the limitations remains the intervention of numerous subjective factors, notably in the establishment of "protocols" and the absence of standardisation in their very structures.

Each year, the "Resistant Brain Pathology" unit of the Department of Neurosurgery takes care of more than a hundred patients who have benefited from treatment with Continuous Electrical Neuromodulation (CEN) in order to respond to a motor symptomatology that is resistant to the usual treatments. The benefits of DBS in the management of abnormal movements have been demonstrated \[2\]. However, this symptomatic treatment does not exclude a worsening of the underlying pathology over time, thereby increasing latent anxiety and promoting the fragility of otherwise severely disabled patients. The management of chronic diseases requires the expertise of a multidisciplinary team so that each aspect contributing to the quality of life of patients can be assessed and supported as best as possible.

In order to improve the quality of life of our patients, a music therapy unit has been established within the multidisciplinary neurosurgery department for two years now. The clinical music therapist attached to the unit has a dedicated room, offering a sensory environment conducive to relaxation and including all the necessary comfort. A standardised protocol for the conduct of the sessions, the organisation and choice of music in direct relation to the different emotions explored on the basis of the permanent perception of heartbeats was developed on the basis of the Webb \& all study \[3\]. When a patient is immersed in a sound bath, identical to that perceived in utero, it would seem that this potentiates the benefits expected from music therapy sessions \[3\].

Our approach, although empirical, shows a decrease in anxiety and an increase in well-being in about fifty patients. Our observations support those highlighted in the literature in other pathologies \[4\] and encourage the use of this approach as a preamble to more specific explorations, in particular the catalysis of certain motor behaviours.

This project is therefore in line with this approach and continuity.

The investigators thus hypothesize that participation in a standardized music therapy protocol (active, receptive and psychomusical relaxation) against a background of regular heartbeats improves the quality of life of the operated patients by acting in particular on a reduction of anxiety and depressive symptoms.

To our knowledge, music therapy has never been proposed in a standardised way to patients with multiple disabilities, operated on and cared for over the long term in a functional neurosurgery department. This approach remains non-invasive and attractive in an often anxiety-provoking hospital context.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Adult subjects (≥ 18 years)
* Meets eligibility criteria: treated with CEN and medically stabilised

Exclusion Criteria:

* Not be available for 3 consecutive months
* Not be able to speak and understand the French language
* Severe disability that would prohibit musical practice according to the investigator (such as tetraparesis, anarthria...)
* Lack of informed consent
* Foreseeable absence from at least 30% of the sessions
* Pregnancy in progress or planned during the study, pregnant or breastfeeding
* Adult protected by law or patient under guardianship or curatorship
* Not residing in Occitania
* Not covered by a social security scheme
* Participation in another ongoing research project
* Complementary therapeutic treatment such as 3rd wave Cognitive Behavioural Therapy (mindfulness or relaxation type)

Primary outcomes:
measure: Change of total score of Quality of life assessment (MOS SF-36) baseline at 1 month and 3 months
timeFrame: The evaluations will take place at three times : at patient inclusion (V0), at 1 month (V1) and at 3 months from the intervention (V2).
Secondary outcomes:
measure: Variation of score in the Quality of life assessment (MOS SF-36)
timeFrame: At patient inclusion (V0), at 1 month (V1) and at 3 months from the intervention (V2).
measure: Hospital Anxiety Depression-Scale (HAD-S)
timeFrame: The evaluations will take place at three times : at baseline (patient inclusion (V0)), at 1 month (V1) and at 3 months from the intervention (V2).
measure: Weel-being Scale (EV.I.BE: Echelle d'évaluation instantanée du Bien-Etre)
timeFrame: The evaluations will take place at three times : at baseline (patient inclusion (V0)), at 1 month (V1) and at 3 months from the intervention (V2).
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Unité Pathologies Cérébrales Résistantes (UPCR) - Département de Neurochirurgie - Gui de Chauliac
Study officials:
affiliation: Montpellier University Hospital
name: Philippe COUBES
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sihvonen AJ, Sarkamo T, Leo V, Tervaniemi M, Altenmuller E, Soinila S. Music-based interventions in neurological rehabilitation. Lancet Neurol. 2017 Aug;16(8):648-660. doi: 10.1016/S1474-4422(17)30168-0. Epub 2017 Jun 26.
citation: Coubes P, Roubertie A, Vayssiere N, Hemm S, Echenne B. Treatment of DYT1-generalised dystonia by stimulation of the internal globus pallidus. Lancet. 2000 Jun 24;355(9222):2220-1. doi: 10.1016/S0140-6736(00)02410-7.
citation: Ribeiro MKA, Alcantara-Silva TRM, Oliveira JCM, Paula TC, Dutra JBR, Pedrino GR, Simoes K, Sousa RB, Rebelo ACS. Music therapy intervention in cardiac autonomic modulation, anxiety, and depression in mothers of preterms: randomized controlled trial. BMC Psychol. 2018 Dec 13;6(1):57. doi: 10.1186/s40359-018-0271-y.
citation: Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
citation: Lord VM, Hume VJ, Kelly JL, Cave P, Silver J, Waldman M, White C, Smith C, Tanner R, Sanchez M, Man WD, Polkey MI, Hopkinson NS. Singing classes for chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2012 Nov 13;12:69. doi: 10.1186/1471-2466-12-69.