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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aleva Neurotherapeutics SA
ClinicalTrials.gov Identifier:
NCT01764815
First received: December 26, 2012
Last updated: March 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Parkinson's Disease
Essential Tremor
Device: directSTN Acute lead connected to external neurostimulator

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders

Resource links provided by NLM:


Further study details as provided by Aleva Neurotherapeutics SA:

Primary Outcome Measures:
  • Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions. [ Time Frame: up to one hour during surgery ] [ Designated as safety issue: No ]
    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:
  • Electrical functionality of the study device during the test phase [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The electrical integrity of the device will be measured before and after its use, to confirm that it was functional throughout the test phase.


Enrollment: 13
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Directional lead Device: directSTN Acute lead connected to external neurostimulator
Test phase will be performed intra-operatively, prior to chronic lead implant

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764815

Locations
Switzerland
Inselspital University Hospital
Bern, Switzerland, 3030
Sponsors and Collaborators
Aleva Neurotherapeutics SA
Investigators
Principal Investigator: Claudio Pollo, PD, Dr. med Inselspital, Bern University Hospital
  More Information

No publications provided

Responsible Party: Aleva Neurotherapeutics SA
ClinicalTrials.gov Identifier: NCT01764815     History of Changes
Other Study ID Numbers: KEK 072-12, CIV-12-08-008482
Study First Received: December 26, 2012
Last Updated: March 20, 2014
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Parkinson Disease
Tremor
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014