NCT05870020 Validation of a Quality of Life Assessment Tool in Adult Generalized Dystonodyskinetic Syndromes Treated by Continuous Electrical Neuromodulation
| NCT ID | NCT05870020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Dystono-dyskinetic Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2023-05-24 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2023-05-24 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT05870020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Dystono-dyskinetic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05870020 currently recruiting?
Yes, NCT05870020 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Montpellier to inquire about joining.
Where is the NCT05870020 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05870020 clinical trial?
NCT05870020 is sponsored by University Hospital, Montpellier. The trial plans to enroll 146 participants.