Predicting Cognition After DBS for Parkinson's Disease

NCT03982953 | Unknown

• 1 other identifier: EA2/040/19
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to improve estimation of cognitive outcome after STN-DBS in PD in order to

• avoid risk factors by optimizing peri- and intraoperative management
• personalize therapeutic strategies for optimal long-term benefit The investigators will test possible predictors (clinical, neuropsychological, neuroimaging, electrophysiological and molecular) for the risk of cognitive dysfunction after deep brain stimulation of the subthalamic nucleus (STN-DBS) in Parkinson's disease (PD) at a single center (Charité - Universitätsmedizin Berlin, Germany). Data collection takes place prior to as well as 3 and 12 months after the STN-DBS operation. Participation is proposed to all PD patients that are planned to undergo STN-DBS after careful examination of eligibility for this treatment according to standard operation procedures.

Conditions

Parkinson's Disease; Deep Brain Stimulation; Postoperativeneurocognitive Deficit; Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• Change in cognitive performance after STN-DBS

  Based on cognitive screening by paper pencil test (MoCA)

  Difference between pre- and 12 months postoperative testing

• Incidence of postoperative neurocognitive disorder

  • According to DSM-5 criteria applying the tablet-based neuropsychological test battery Cambridge Neuropsychological Test Automated Battery (CANTAB connect)

  Difference between pre- and 3 and 12 months postoperative testing

Study Arms (2)

PD patients with STN-DBS

Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that are planned to undergo craniectomy with implantation of bilateral DBS electrodes in the subthalamic nucleus

Controls - PD patients with medical treatment

Patients with the diagnosis of Levodopa responsive idiopathic Parkinson's Disease that do not undergo DBS for personal reasons or contraindications for this treatment. Age, sex and disease-severity matched with PD patients with STN-DBS.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD patients that are planned to undergo STN-DBS. Possible contraindications to DBS are tested according to clinic-intern standard operation procedures. Tests include * Clinical scales: DemTect, MMST, ADL, MDS-UPDRS I-IV including video documentation of MDS-UPDRS III on and off dopaminergic medication * Questionnaires: expectations regarding DBS, PDQ39, BDI, Starkstein-Apathie-Skala, QUIP(-RS) * General examinations: Routine laboratory, ECG, TTE, Chest X-Ray, lung function, 24h-RR, Duplex sonography of extracranial arteries * Expert opinion from related fields: Neuropsychological exam, psychiatric examination, neurosurgery and anesthisiologic consultation

You may qualify if:

• Diagnosis of idiopathic Parkinson's Disease
• Indication for STN-DBS

You may not qualify if:

• Internistic, surgical or psychiatric contrainidications with respect to the DBS operation or treatment for the STN-DBS group
• Dementia
• Relevant language barrier

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 13351, Germany

RECRUITING

Related Publications (1)

• Kubler-Weller D, Stuke H, Astalosch M, Martins Ribeiro L, Landfried E, Schneider GH, Faust K, Krause P, Roediger J, Haufe S, Mousavi M, Al-Fatly B, Spies C, Borchers F, Kuhn AA. Predicting cognition after subthalamic Deep Brain Stimulation in Parkinson's Disease. NPJ Parkinsons Dis. 2025 Aug 28;11(1):265. doi: 10.1038/s41531-025-01128-3.

  PMID: 40877314 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cholinergic biomarkers in cerebrospinal fluid (CSF) * TAU, phospho-TAU, ß-Amyloid 1-40 and 1-42 * measured in CSF preoperatively

MeSH Terms

Conditions

Parkinson Disease; Emergence Delirium

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Andrea A Kühn, Prof. MD

  Neurology, Head of the Movement Disorders and Neuromodulation Section

  STUDY DIRECTOR

Central Study Contacts

Dorothee Kübler, MD

CONTACT

+4930450660528; dorothee.kuebler@charite.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc and MD

Study Record Dates

• First Submitted: June 9, 2019
• First Posted: June 12, 2019
• Study Start: June 12, 2019
• Primary Completion: June 10, 2022
• Study Completion: August 10, 2022
• Last Updated: May 7, 2021

Record last verified: 2021-05

Locations

DE (1)