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

Not Applicable

• Conditions: G20; G25; Parkinson disease; Other extrapyramidal and movement disorders

• Registration Number: DRKS00012667
• Lead Sponsor: niversitätsklinikum Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-24
• Study Completion: 2018-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 14

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Comparison of effect on tremor of 1. monopolar, 2. conventional bipolar, and 3. directional bipolar stimulation.<br>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<br>