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Bipolar directional stimulation to reduce side-effects in deep brain stimulation of the thalamus

Bipolar directional stimulation to reduce side-effects in deep brain stimulation of the thalamus - BiDirect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00012667
Enrollment
12
Registered
2017-07-24
Start date
2017-04-27
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 G25

Interventions

Group 1: Monopolar stimulation: each patient will be programmed consecutively and in a randomized order in the following different stimulation-settings: monopolar stimulation, conventional bipolar sti

Sponsors

Universitätsklinikum Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of essential tremor or tremordominant Parkinson's disease - Implantation of DBS-electrodes in the Ventral intermediate nucleus thalami (VIM) for at least 3 months - Age between 18 and 80 years - Full understanding of all study related procedures and ability to sign the written informed consent

Exclusion criteria

Exclusion criteria: - no withdrawal of medication over night possible - dementia or other relevant cognitive impairment

Design outcomes

Primary

MeasureTime frame
Comparison of side-effect thresholds between 1. monopolar, 2. conventional bipolar, and 3. directional bipolar stimulation. Prim. Outcome: immediate treshold (in mA) of side effects in the different stimulation settings during a monopolar review

Secondary

MeasureTime frame
Comparison of effect on tremor of 1. monopolar, 2. conventional bipolar, and 3. directional bipolar stimulation. Sec. Outcome: Tremor Rating Scale Total Score of patient when stimulating just below the treshold of side effects, 15 minutes after the stimulation ist programmed

Countries

Germany

Contacts

Public ContactJulia K. Steffen

Klinik und Poliklinik für Neurologie, Uniklinik Köln

julia.steffen@uk-koeln.de+492214784013

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026