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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Essential Tremor
• Intervention / Treatment: Device: directSTN Acute lead connected to external neurostimulator

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3030
    • Inselspital University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Directional lead	Device: directSTN Acute lead connected to external neurostimulator; Test phase will be performed intra-operatively, prior to chronic lead implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aleva Neurotherapeutics SA
• Investigators: Principal Investigator: Claudio Pollo, PD, Dr. med, Inselspital, Bern University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: December 26, 2012
• First Submitted That Met QC Criteria: January 8, 2013
• First Posted (Estimate): January 10, 2013

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Essential Tremor
• Other Study ID Numbers: KEK 072-12; CIV-12-08-008482 (Other Identifier: EUDAMED)