EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01796483
• Date of registration: 13/02/2013
• Prospective Registration: No
• Primary sponsor: Hospices Civils de Lyon
• Public title: EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PD EEGDBSNAd
• Scientific title: Exploration électroencéphalographie et Pharmacologique Des Dysfonctionnements exécutifs Induits Par la Stimulation cérébrale Profonde du Noyau Sous-thalamique Dans la Maladie de Parkinson
• Date of first enrolment: October 2012
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01796483
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 40 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Device: Clonidine (Catapressan)

Device: Placebo 90 minutes before EEG

Primary Outcome(s)

comparision placebo vs Clonidine [Time Frame: Primary outcome data will be analyzed at the completion of the study, i.e. after the planned 18-month duration of data collection from patients and control subjects.]

Secondary Outcome(s)

Localisation of the sources of activity [Time Frame: Secondary outcome data will be analyzed at the completion of the study, i.e. after the planned 18-month duration of data collection from patients and control subjects.]

Secondary ID(s)

2012.712

Source(s) of Monetary Support

Please refer to primary and secondary sponsors