MEG in Parkinson¡¯s disease patients with DBS

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19892

Enrollment

Registered

2017-08-09

Start date

2017-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease, Deep Brain Stimulation

Interventions

In each subject, eleven MEG recordings of 5 minutes duration will be completed in a single session. The first MEG recording will be performed in the optimal DBS settings of the participant. After this

Eligibility

Inclusion criteria

Inclusion criteria: -Having undergone STN-DBS placement for PD six months or longer before MEG registrations; -Age ¡Ý 18 years; -Monopolar stimulation -Pre-operative DTI data available and of sufficient quality. -Post-operative NPO is available and was performed in the same DBS settings as during the MEG recordings.

Exclusion criteria

Exclusion criteria: -Hoehn and Yahr stage higher than 3, as determined in the DBS ON- (but medication OFF-)state. -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; -Dementia according to the Movement Disorder Society criteria for PD with dementia. -Conditions that will cause excessive MEG artefacts (other than the DBS electrode and stimulator). -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;

Design outcomes

Primary

Measure	Time frame
Stimulation site-specific neurophysiological measures, as obtained by MEG recordings, and differences in the exact locations and structural connections of each contact point, as obtained by brain imaging. -Correlation of neurophysiological- and structural data to clinical measures of non-motor symptoms (both pre- and post-DBS), obtained in the context of standard clinical care and clinical studies.	—

Measure

Time frame

Stimulation site-specific neurophysiological measures, as obtained by MEG recordings, and differences in the exact locations and structural connections of each contact point, as obtained by brain imaging. -Correlation of neurophysiological- and structural data to clinical measures of non-motor symptoms (both pre- and post-DBS), obtained in the context of standard clinical care and clinical studies.

—

Secondary

Measure	Time frame
MDS-UPDRS III-ratings are scored on a regular basis as part of clinical care and can be correlated to the functional and structural networks as well.	—

Contacts

Public ContactH.W. Berendse

VU University Medical Center, Amsterdam

h.berendse@vumc.nl+31 204442830

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)