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Deep Brain Stimulation Effects Study

NCT01098565 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-08-02

No results posted yet for this study

Summary

The purpose of this study is to provide proof-of-concept that the test product can perform as intended in an intra-operative setting and the responses to the test product are perceivable in a person. The study will also compare results of the test product to the commercially-available product.

Hypothesis: the test product will elicit successful test results in over 90% of test product.

Conditions

Interventions

DEVICE

Study device HFR0001

Study device will be tested for up to 2 hours prior to chronic device implant.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • H. Maximilian Mehdorn, MD, PhD · University Clinics Kiel, Department of Neurosurgery

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098565 on ClinicalTrials.gov