Safety and Feasibility of low-frequent Co-Stimulation in Parkinson´s Disease

Safety and Feasibility of low-frequent Co-Stimulation in Parkinson´s Disease - DUST-PD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035880

Enrollment

Registered

2025-01-27

Start date

2025-01-28

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

G20

Interventions

Group 1: Control stimulation (clinically etablished): In Phase 1 or Phase 2 (cross-over design), patients receive continuous deep brain stimulation in gamma frequency in the motor (dorsolateral) part

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Clinically established diagnosis of Parkinson's disease - Bilateral implantation of directional electrodes for deep brain stimulation in the subthalamic nucleus at least 10 weeks prior to the start of the study - Stimulation system capable of dual stimulation (Boston Scientific Vercise™ Gevia/Genus) - Imaging-confirmed intranuclear positioning of the stimulation electrodes - Oral and written informed consent

Exclusion criteria

Exclusion criteria: - Clinically relevant cognitive impairment - Levodopa dysregulation syndrome - Severe affective disorder - Disabling postural instability - Inability or unwillingness to independently switch stimulation programs using the patient remote control

Design outcomes

Primary

Measure	Time frame
Primary endpoints are the rates of adverse events (AEs) and severe adverse events (SAEs), as well as the dropout rate of the study. Using a standardized registration form, all adverse events and severe adverse events are documented according to the Common Terminology Criteria for Adverse Events (CTCAE). Data collection occurs through telephone reporting by the patients during the intervention phases, and targeted inquiries are conducted at the end of each intervention phase.	—

Measure

Time frame

Primary endpoints are the rates of adverse events (AEs) and severe adverse events (SAEs), as well as the dropout rate of the study. Using a standardized registration form, all adverse events and severe adverse events are documented according to the Common Terminology Criteria for Adverse Events (CTCAE). Data collection occurs through telephone reporting by the patients during the intervention phases, and targeted inquiries are conducted at the end of each intervention phase.

—

Secondary

Measure	Time frame
Secondary endpoints involve data collection from various symptom-related, disease-specific questionnaires as well as the results of administering a computer-based test battery to measure executive functions. At the end of the study day, after the two intervention phases, and three months following the conclusion of the intervention phases, questionnaires are collected (on-site on the study day and by telephone at the other three time points) to descriptively assess symptom control and participants' quality of life. On the study day, brief cognitive tests are conducted under three different conditions on the computer to descriptively investigate the acute effects of the stimulation conditions on executive functions.	—

Measure

Time frame

Secondary endpoints involve data collection from various symptom-related, disease-specific questionnaires as well as the results of administering a computer-based test battery to measure executive functions. At the end of the study day, after the two intervention phases, and three months following the conclusion of the intervention phases, questionnaires are collected (on-site on the study day and by telephone at the other three time points) to descriptively assess symptom control and participants' quality of life. On the study day, brief cognitive tests are conducted under three different conditions on the computer to descriptively investigate the acute effects of the stimulation conditions on executive functions.

—

Countries

Germany

Contacts

Public ContactMichael Thomas Barbe

Universität zu Köln

michael.barbe@uk-koeln.de+49 221 478 7479

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026