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

NCT ID: NCT01764815

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-11-30

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.

Conditions

Parkinson's Disease; Essential Tremor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Directional lead

Group Type: EXPERIMENTAL

directSTN Acute lead connected to external neurostimulator

Intervention Type: DEVICE

Test phase will be performed intra-operatively, prior to chronic lead implant

Interventions

directSTN Acute lead connected to external neurostimulator

Test phase will be performed intra-operatively, prior to chronic lead implant

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aleva Neurotherapeutics SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Pollo, PD, Dr. med

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern University Hospital

Locations

Inselspital University Hospital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

CIV-12-08-008482

Identifier Type: OTHER

Identifier Source: secondary_id

KEK 072-12

Identifier Type: -

Identifier Source: org_study_id