Clinical trial NCT05870020: Validation of a Quality of Life Assessment Tool in Adult Generalized Dystonodyskinetic Syndromes Treated by Continuous Electrical Neuromodulation
Official title: Validation of a Quality of Life Assessment Tool in Generalized Dystonodyskinetic Syndromes Treated With Continuous Electrical Neuromodulation (CEN): The "Dystono-dyskinetic BrethoméSanrey Quality of Life" Scale (DBS-QoLs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dystono-dyskinetic Syndromes
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In spite of a growing interest in the evaluation of health-related quality of life in movement's disorders management, there is no tool specifically dedicated to dystonia and related syndromes that measures both the objective severity of the handicap and the patient's feelings about the surgical treatment in terms of subjective improvement. We have been working for several years at the bedside of patients operated on in the " pathologies cérébrales résistantes " Unit on the development of a related questionnaire to assess both the motor severity and the patients' feelings about the evolution of their disease under Deep Brain Stimulation (DBS).

The self-questionnaire designed would allow to a certain extent to get away from the two gold standards currently used in the field, i.e. the Burke, Fahn \& Marsden Dystonia Rating Scale (BFMDRS) and the SF-36, thus facilitating the evaluation and allowing a homogenization of the practices for the different implanting centers on the french territory.

Detailed description: The construction of the tool in its particular design, including various targeted modules, stems from an experience of more than ten years acquired with patients treated by deep brain stimulation in the unit. The self-questionnaire thus obtained will be sent to 146 patients with generalized dystonodyskinetic syndrome, operated and followed in the unit, and submitted to various statistical analyses. The scores of the identified dimensions will be compared with the etiology of the abnormal movements (primary vs. secondary) as well as with the results obtained with the two scales currently used to evaluate abnormal movements (BFMDRS) and/or quality of life (SF-36) and finally with the patients' mood during their follow-up (BDI, STAI). Tolerance to surgery will also be measured.

Eligibility criteria: Inclusion Criteria:

* Adulte between 18 an 80 years
* Patient with a generalized dystono-dyskinetic syndrome treated by Electrical Neuromodulation Continue and follow-up in the unit
* Subject affiliated to the French social security system

Exclusion Criteria:

* non-French speaker
* patients who are physically unable to answer the questionnaire and who have no trusted person to help
* severe cognitive impairment (MoCA \<10, MDRS \<123, PM-38 \<70)
* lack of informed consent

Primary outcomes:
measure: Ability to perform different activities assessed by DBS-QOLs
timeFrame: 1 year
measure: Psycho-social assessment by DBS-QOLs
timeFrame: 1 year
measure: Intervention's assessment by DBS-QOLs
timeFrame: 1 year
measure: Life's Quality assessment by DBS-QOLs
timeFrame: 1 year
Secondary outcomes:
measure: External validity of the DBS-QOLs compared to the BFMDRS for the functional subscale
timeFrame: 1 year
measure: External validity of the DBS-QOLs compared to the Beck Depression Inventory score for Thumia
timeFrame: 1 year
measure: External validity of the DBS-QOLs compared to the SF-36 for Life's quality
timeFrame: 1 year
measure: External validity of the reproducibility of the DBS-QOLs compared to the BFMDRS
timeFrame: 1 year
measure: External validity according to different clinical criteria or scales : sensitivity to change
timeFrame: 1 year
measure: Assessment of the correlation between the functional fain & the benefit felt by the patient with the DBS-QOLs
timeFrame: 1 year
measure: Assessment of the tolerance to surgery by the DBS-QOLs
timeFrame: 1 year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
state: Hérault
Study officials:
References: