Intra-operative evaluation of efficacy and safety of a new lead for steering Deep Brain Stimulation. First Acute-in-Man Evaluation of Steering Brain Stimulation (FAME )

Intra-operative evaluation of efficacy and safety of a new lead for steering Deep Brain Stimulation. First Acute-in-Man Evaluation of Steering Brain Stimulation (FAME ) - FAME

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39039

Enrollment

Registered

2012-08-09

Start date

2012-10-22

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Parkinson's Disease stifness tremors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Diagnosis of idiopathic Parkinson*s disease • Clinical indication for STN DBS with MER. • Age > 18 years • Subject is a male or non-pregnant female • Ability to comply with the study assignments. • Ability to give informed consent.

Exclusion criteria

Exclusion criteria: • Parkinson*s disease graded according to Hoehn and Yahr stage 5 • Score on MATTIS dementia rating scale

Design outcomes

Primary

Measure	Time frame
1) To confirm that stimulation through the Sapiens lead is safe and able to produce equivalent effects as stimulation through currently available commercial DBS leads.	—

Secondary

Measure	Time frame
2) To establish that steering stimulation with the Sapiens lead modulates the threshold for stimulation-induced effects as found in ring mode through the same Sapiens lead	—

Countries

Netherlands

Outcome results