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Clinical Trial Summary

The study is an open-label trial to validate the local field potential (LFP) activity in the subthalamic nucleus (STN) for slow-wave detection during acoustic stimulation during nighttime sleep in Parkinson's disease patients that receive deep-brain-stimulation (DBS) therapy with the novel PERCEPT™ DBS system.

Clinical Trial Description

The objective of this study is to validate the STN signal for slow-wave detection during auditory stimulation. To test this, the electrophysiological activity within the STN will be measured as local field potentials (LFP) using standard STN-DBS electrodes. To assess whether the recorded STN activity can be used for AS, the coherence analysis of cortical and STN slow waves will be performed. At the screening consultation, the study physician will obtain written informed consent, confirm inclusion and exclusion criteria, and obtain entry questionnaires including demographics, medical history, and concomitant therapy. Following a successful screening consultation, the study physician will schedule a screening night at the sleep laboratory in the department of Neurology, University Hospital Zurich (USZ), during which clinical surface EEG (12-channel system, including EMG, ECG, and EOG) will be recorded and AS will be applied. To test the individual susceptibility to AS, ERPs to auditory stimuli and SWA change will be assessed. If the screening night was successful, each patient will undergo a baseline consultation and 3 recording sessions. During all 3 recording sessions, the patients will be asked about their subjective sleep quality and current mood, concomitant therapy (including LED), and MDS-UPDRS III will be performed by the study physician. The surgical implantation (which is not part of the current proposal) follows standardized clinical protocol and is applied in 2 steps. Sleep will be recorded simultaneously with clinical surface EEG and STN LFP in all 3 recording sessions (combined LFP-EEG recording) and AS will be performed based on slow-wave detected in the surface EEG. In detail: In the first step, DBS leads are implanted in the STN, keeping the wires externalized. Following one night in the intensive or intermediate care unit for monitoring, patients will undergo a full-night combined LFP-EEG recording and AS (Recording Session 1), with LFP data collected from the externalized wires (DBS off). Next, the surgery will be completed by implantation of the neuromodulator and its connection to the DBS leads. Following the completion of the surgery, rehabilitation will start. The rehabilitation period will last for 2-5 weeks. At the end of the rehabilitation Recording Session 2 and 3 will take place. These recording session will be separated by 2-3 days and their order will be randomized and counterbalanced across participants. During Recording Session 2, combined LFP-EEG recording and AS will be performed during first 4 hours of the night sleep; STN LFP will be recorded with the implanted neurostimulator (DBS off). Recording Session 3 will be similar to Recording Session 2, but with DBS on (i.e. using DBS settings that were adjusted during rehabilitation). Because stable LFP recordings by PERCEPT™ PC neurostimulator is only possible for 4 hours, LFP sleep recordings during Recording Session 2 and 3 are limited to the first 4h of sleep. Surface EEG and AS, however, will be performed for the whole night after the LFP recoding end. Recording Sessions 2 and 3 will take place either at Clinic Lengg or in the USZ sleep laboratory (if the patient will be at a different rehabilitation center than Clinic Lengg). Additionally, circadian rhythm will be assessed continuously throughout the interventions using actigraphy. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05184270
Study type Interventional
Source University of Zurich
Contact Sara Fattinger, PhD
Phone +41432530312
Email [email protected]
Status Recruiting
Phase N/A
Start date November 10, 2021
Completion date October 30, 2023

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