Validation of a quality of life assessment tool for patients with dystono-dyskinetic syndromes
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)
This study is testing a new questionnaire to see how well it can measure the quality of life for adults with dystono-dyskinetic syndromes who are getting treatment with electrical stimulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Hérault) |
| Trial ID | NCT05870020 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a self-questionnaire designed to assess the quality of life in adults with generalized dystonodyskinetic syndromes who are treated with continuous electrical neuromodulation. The questionnaire will evaluate both the objective severity of the condition and the patients' subjective feelings about their treatment outcomes. A total of 146 patients will participate, and their responses will be statistically analyzed and compared with existing evaluation scales. The goal is to create a standardized tool that can be used across different treatment centers in France.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with generalized dystonodyskinetic syndromes who have undergone electrical neuromodulation treatment.
Not a fit: Patients who are non-French speakers, have severe cognitive impairments, or are physically unable to complete the questionnaire will not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could provide a more accurate and comprehensive assessment of quality of life for patients with dystonodyskinetic syndromes, leading to improved treatment strategies.
How similar studies have performed: While there is growing interest in quality of life assessments in movement disorders, this specific approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier, Hérault
- CHU Montpellier — Montpellier, Hérault, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.