Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pall… (NCT00505323) | Clinical Trial Compass
CompletedPhase 1
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
5 participantsStarted 2007-09
Plain-language summary
Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage.
Cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. This is the aim of the present study.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age : \>18 years and \< 65 years
* Evolution time of dystonia \> 1 year
* Clinical stability of dystonia = 1 year
* Secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei
* Inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.)
* Stability of treatment \>3 months
* Agreement of patients
* Affiliation to social security
Exclusion Criteria:
* Significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases
* Significant clinical and biological anomalies
* Disease or treatment in favour in bleeding
* Sever cognitive disorders
* Psychiatric evolutionary pathology
* Counter-indication during inclusion examination
* Chirurgical counter-indication
* Pregnant women ou women who nurse
* Person who participate to an other study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale
Timeframe: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after