Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation (DBS) Leads

Not Applicable

Completed

• Conditions: Essential Tremor; Parkinson's Disease
• Interventions: Device: directSTN Acute lead connected to external neurostimulator

• Registration Number: NCT01764815
• Lead Sponsor: Aleva Neurotherapeutics SA

Brief Summary

The purpose of this study is to provide proof-of-concept that directional stimulation, in an intraoperative setting, is perceivable in a subject and is different from omnidirectional stimulation. The tests will be performed using a dedicated DBS lead connected to external neurostimulator.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-26
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Subject is indicated to undergo DBS for Parkinson's disease or Essential Tremor according to criteria of the Study site

• For Parkinson Disease:

  • Person is between 18 and 75 years of age
  • Established diagnosis of idiopathic Parkinson's disease with progression of symptoms for a minimum of 2 years.
  • Person has a history of at least 30% improvement on the Unified Parkinson's Disease Rating Scale with therapy in L-dopa (levodopa)
  • Weak control of symptoms by dopaminergic therapy (off phenomenon, fluctuations on / off, dyskinesia on)

• For Essential Tremor:

  • Person is between 18 and 80 years of age
  • Established diagnosis of Essential Tremor for a minimum of 2 years
  • Functional disability due to tremor was not adequately controlled by medication for at least 3 months prior to implant.

• Person has given his/her written consent

Exclusion Criteria

• Person suffering from an active major psychiatric disorder
• Mattis Dementia Rating Scale score <130 or otherwise not capable of discernment
• Presence of major co-morbidity or medical condition that may affect participation to the study
• Presence of an electrical or electromagnetic implant (e.g., cochlear implant, pacemaker)
• Person with a previous surgery for the treatment of Parkinson's disease or Essential Tremor
• Person with a previous brain ablation procedure
• Person who suffers from epilepsy
• Person who is pregnant: a pregnancy test will be performed in women of childbearing age
• Person with coagulopathies
• Abuse of drugs or alcohol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Directional lead	directSTN Acute lead connected to external neurostimulator	-

Primary Outcome Measures

Name	Time	Method
Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.	up to one hour during surgery	A therapeutic window is defined as the difference between the electrical current threshold at which a desired therapeutic effect is obtained and the current threshold at which side effects appear.

Secondary Outcome Measures

Name	Time	Method
Electrical functionality of the study device during the test phase	1 day	The electrical integrity of the device will be measured before and after its use, to confirm that it was functional throughout the test phase.

Trial Locations

Locations (1)

Inselspital University Hospital; 🇨🇭 Bern, Switzerland