Functional brain network changes as indicators of deep brain stimulation-induced cognitive and psychiatric side effects in Parkinson*s disease related to electrode contact points: a proof of concept study

Completed

• Conditions: idiopathic parkinsonism; paralysis agitans; Parkinsons disease; 10028037; 10009720

• Registration Number: NL-OMON46346
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

-Having undergone STN-DBS placement for PD six months or longer before MEG registrations;
-Age * 18 years;
-Written informed consent for the study;
-Monopolar stimulation (this restriction was chosen in order to improve inter-individual comparability);
-Pre-operative DTI data available and of sufficient quality. The patient*s nose should be included in at least one pre-operative MRI to allow optimal co-registration with the MEG data;
-Post-operative NPO is available and was performed in the same DBS settings as during the MEG recordings.

Exclusion Criteria

-Hoehn and Yahr stage (41) higher than 3, as determined in the DBS ON- (but medication OFF-)state during the visit to the outpatient clinic to establish the optimal DBS-settings, approximately ten days after surgery;
-Anatomical deformities that prevent the subject from undergoing an MEG registration in supine position (i.e. thoracic kyphosis);
-Continuous intrajejunal levodopa or subcutaneous apomorphine infusion in addition to DBS;
-Subjects who cannot read, speak or understand Dutch;
-Dementia according to the Movement Disorder Society criteria for PD with dementia (43). Mental competence is necessary in order to give informed consent for participation in the study and to follow instructions during MEG recordings. Minor cognitive decline post-DBS is not an exclusion criterion, since this is one of the outcome parameters of this study;
-Conditions that will cause excessive MEG artefacts (other than the DBS electrode and stimulator). A list of items that cause MEG signal perturbation is given in the participants information folder, on a poster at the entrance of the MEG system, and in this document (section 11);
-A history of stroke or major vascular lesions on brain MRI;
-A history of major traumatic brain injury;
-Peri-operative intracerebral complications (e.g. bleeding or infection) related to STN-DBS placement inflicting permanent changes;

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are stimulation site-specific neurophysiological<br /><br>measures, as obtained by MEG recordings, and individual differences in the<br /><br>exact locations and structural connections of each stimulation site, as<br /><br>obtained by pre- and post-DBS brain imaging. These network parameters will be<br /><br>correlated with clinical measures of cognitive and psychiatric side effects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N.a.</p><br>