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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023115

Enrollment

Registered

2020-10-05

Start date

2020-09-23

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G20

Interventions

Group 1: Arm 1: Image-guided stimulation setting. Total electrical current as well as its percental distribution across electrode contacts suggested by algorithm based on electrode reconstructions. Gr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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%.	—

Countries

Germany

Contacts

Public ContactJan Roediger

Charite´ - Universita¨tsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie, Abteilung Bewegungsstörungen und Neuromodulation

jan.roediger@charite.de+49 30-450 660 207

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026