Predicting Cognition After DBS for Parkinson's Disease 2

NCT06272968 | Active Not Recruiting

• 1 other identifier: EA2/252/23
• Study Type: observational
• Target: 30
• 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, 12 and 60 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

Cognitive Impairment

Keywords

Cognitive Impairment; Parkinson's disease; Deep Brain Stimulation; Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• Change in cognitive performance after STN-DBS

  Based on cognitive screening by Cambridge CANTAB Connect

  Difference between baseline, 12 and 60 months postoperative testing

• Incidence of postoperative neurocognitive disorder

  Based on cognitive screening by paper pencil test (MoCA or MDRS)

  Difference between baseline, 12 and 60 months postoperative testing

Secondary Outcomes (1)

• Validation of post-hoc model from prior study (NCT03982953)

  1 year after DBS surgery

Interventions

Neuropsychological Testing DIAGNOSTIC_TEST

Neuropsychological Testing via Cambridge CANTAB Connect

Eligibility Criteria

• Age: 18 Years - 80 Years
• 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.

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

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease; Emergence Delirium

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; 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

Study Officials

• Dorothee Kübler-Weller, MD

  Movement Disorders and Neuromodulation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Senior Physician

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 22, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

DE (1)