Status:
COMPLETED
EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Parkinson Disease
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) remarkably improves motor functions in patients with Parkinson disease (PD). However, growing evidence suggests that STN-DBS also causes e...
Eligibility Criteria
Inclusion
- For all right-handed participants :
- Age between ≥ 40 and ≤ 70 years old ;
- Weight between 45 and 95 kg
- Without cognitive deterioration (MATTIS score \> 130) ;
- Without orthostatic hypotension known;
- Showing no contraindication to clonidine:
- Hypersensibility known to clonidine or to an excipient of Catapressan
- Depressed state
- Severe bradyarrythmias due to a sinus node disease or atrioventricular block ventricular second or third degree ;
- Treatment by sultopride;
- Showing no contraindication to the placebo of clonidine : lactose intolerance;
- Affiliated to a social security scheme or assimilated;
- Not being the subject of a measure of legal protection;
- Having consented to participate in the study and written inform consent.
- Specific to right-handed parkinsonian patients :
- Having an idiopathic Parkinson's disease Dopa-sensitive;
- Treated with deep brain stimulation of the subthalamic nucleus since at least 3 months;
- With stable antiparkinsonian treatment for at least 2 months and that it will be possible not to modified during the entire experiment;
- Specific to right-handed healthy controls :
- • Without a history of neurologic or psychiatric disease
Exclusion
- For all the participants:
- Having somatic medication treatment with a cerebral or psychic impact;
- Presenting dependence and abuse to cannabis or to other addictive substance according to the DSM-IV-TR, with the exception of tobacco;
- Already participating to another biomedical research except surgical project involving a new material of deep brain stimulation because in this case stimulation parameters and patients benefiting of it will be the same;
- Pregnant or breastfeeding women (diagnostic examination);
- Subjects having, after reading questionnaires or after the medical examination, contraindication to EEG exam or to clonidine.
- Specific to parkinsonian patients:
- Having other neurologic or psychiatric associated pathology, notably depression;
- Already participating to another biomedical research except surgical project involving a new material of deep brain stimulation because in this case stimulation parameters and patients benefiting of it will be the same;
- Pregnant or breastfeeding women (diagnostic examination); Subjects having, after reading questionnaires or after the medical examination, contraindication to EEG exam or to clonidine.
- Specific to healthy subjects :
- Already participating to another biomedical research;
- Subjects who exceeded the annual compensation allowed for participation in research protocols;
- Subjects with an inability to understand or carry out the study (language barrier, mental disability, obvious lack of motivation…) judged by the investigator
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01796483
Start Date
October 1 2012
End Date
June 1 2016
Last Update
May 28 2019
Active Locations (1)
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1
Hospices Civils de Lyon Hôpital Pierre Wertheimer
Bron, France, 69677