Imaging-based selection of the stimulation parameters of deep brain stimulation in patients with idiopathic Parkinson's syndrome

Not Applicable

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00023115
• Lead Sponsor: Charité – Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie, Abteilung Bewegungsstörungen und Neuromodulation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Study Completion: 2021-10-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Consenting patient
- Minimum age 18 years
- Oral and written informed consent
- Diagnosis of an IPS of the akinetic-rigid or equivalent type according to the criteria of the British Parkinson's Disease Society Brain Bank
- Successful implantation of electrodes for deep brain stimulation in the STN area within the last 2.5 years

Exclusion Criteria

- Presence of a tremor-dominant subtype according to the criteria of (Stebbins et al., 2013)
- Severe complications, such as bleeding or systemic infection during THS implantation or postoperative course
- Pronounced psychiatric accompanying symptoms (dementia, affective disorders, psychosis)
- Significant limitations of cognitive functions and the ability to express oneself

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is absolute motor improvement (measured by the overall MDS-UPDRS-III score) compared to motor function without stimulation under the respective stimulation settings. The non-inferiority of setting A compared to setting B is examined by means of a t-test for period differences, a one-sided alpha of 5% and a non-inferiority limit of 5 points. This limit has been defined according to FDA guidelines (Nov 2016) based on clinical considerations.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are motor improvement (ordinal scaled between 0 and 4) and side effect thresholds (measured in mA) as determined in the monopolar review. The contacts are ranked based on these values and the contact sequences are correlated with the contact sequences predicted by the algorithm across cohorts (Spearman correlation). The significance level alpha is 5%.