Validation of a Quality of Life Assessment Tool in Adult Generalized Dystonodyskinetic Syndromes Treated by Continuous Electrical Neuromodulation

NCT05870020 | Terminated

• 1 other identifier: RECHMPL22_0228
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystono-dyskinetic Syndromes

Outcome Measures

Primary Outcomes (4)

• Ability to perform different activities assessed by DBS-QOLs

  Ability to perform different activities assessed by the Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale (DBS-QOLs) with the evaluation of the ability to perform different activities (from impossible to autonomous) and then to estimate the evolution of this ability since the intervention (worsening, no change, improvement)

  1 year

• Psycho-social assessment by DBS-QOLs

  Psychosocial assessment by the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no/partially questions related to the emotional and psychological perception of patients and then to estimate the evolution of this thought since the intervention (worsening, no change, improvement)

  1 year

• Intervention's assessment by DBS-QOLs

  Intervention's assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no question related to the intervention.

  1 year

• Life's Quality assessment by DBS-QOLs

  Life's Quality assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with squales from 0 (worst case) to 10 (best case).

  1 year

Secondary Outcomes (7)

• External validity of the DBS-QOLs compared to the BFMDRS for the functional subscale

  1 year

• External validity of the DBS-QOLs compared to the Beck Depression Inventory score for Thumia

  1 year

• External validity of the DBS-QOLs compared to the SF-36 for Life's quality

  1 year

• External validity of the reproducibility of the DBS-QOLs compared to the BFMDRS

  1 year

• External validity according to different clinical criteria or scales : sensitivity to change

  1 year

Study Arms (1)

Adults with dystono-diskinetic syndrome treated by depp brain stimulation in the unit.

EXPERIMENTAL

Other: Questionnaire (DBS-QoLs)

Interventions

Questionnaire (DBS-QoLs) OTHER

The DBS-QoLs questionnaire will be sent to the patients for answer: The questonnaire will be sent at : * the inclusion * 15 days after the inclusion * 1 year after the inclusion

Adults with dystono-diskinetic syndrome treated by depp brain stimulation in the unit.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, Hérault, 34295, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 23, 2023
• Study Start: May 24, 2023
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: July 9, 2026

Record last verified: 2026-07

Locations

FR (1)