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

Parkinson's Disease Clinical Trial

Official title:

Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764815
• Other study ID #: KEK 072-12
• Secondary ID: CIV-12-08-008482
• Status: Completed
• Phase: N/A
• First received: December 26, 2012
• Last updated: June 30, 2017
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2017
• Source: Aleva Neurotherapeutics SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• directSTN Acute lead connected to external neurostimulator
Test phase will be performed intra-operatively, prior to chronic lead implant

Locations

Country	Name	City	State
Switzerland	Inselspital University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Aleva Neurotherapeutics SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.	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.	up to one hour during surgery
Secondary	Electrical functionality of the study device during the test phase	The electrical integrity of the device will be measured before and after its use, to confirm that it was functional throughout the test phase.	1 day