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

This study has been completed.
Information provided by (Responsible Party):
Aleva Neurotherapeutics SA Identifier:
First received: December 26, 2012
Last updated: March 20, 2014
Last verified: January 2014
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: Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, 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 ]
    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 ]
    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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01764815

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

Responsible Party: Aleva Neurotherapeutics SA Identifier: NCT01764815     History of Changes
Other Study ID Numbers: KEK 072-12
CIV-12-08-008482 ( Other Identifier: EUDAMED )
Study First Received: December 26, 2012
Last Updated: March 20, 2014

Additional relevant MeSH terms:
Parkinson Disease
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases processed this record on May 25, 2017