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

Primary Purpose

Parkinson's Disease, Essential Tremor

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
directSTN Acute lead connected to external neurostimulator
Sponsored by
Aleva Neurotherapeutics SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inselspital University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Directional lead

Arm Description

Outcomes

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.
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
The electrical integrity of the device will be measured before and after its use, to confirm that it was functional throughout the test phase.

Full Information

First Posted
December 26, 2012
Last Updated
June 30, 2017
Sponsor
Aleva Neurotherapeutics SA
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1. Study Identification

Unique Protocol Identification Number
NCT01764815
Brief Title
Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation (DBS) Leads
Official Title
Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aleva Neurotherapeutics SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Essential Tremor

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Directional lead
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
directSTN Acute lead connected to external neurostimulator
Intervention Description
Test phase will be performed intra-operatively, prior to chronic lead implant
Primary Outcome Measure Information:
Title
Measurement of the therapeutic window's boundaries when stimulating in specific angular directions, and comparison to those obtained when stimulating in all directions.
Description
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.
Time Frame
up to one hour during surgery
Secondary Outcome Measure Information:
Title
Electrical functionality of the study device during the test phase
Description
The electrical integrity of the device will be measured before and after its use, to confirm that it was functional throughout the test phase.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Pollo, PD, Dr. med
Organizational Affiliation
Inselspital, Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital University Hospital
City
Bern
ZIP/Postal Code
3030
Country
Switzerland

12. IPD Sharing Statement

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

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