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CompletedNCT01764815Updated Jul 2, 2017

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

An interventional study of directSTN Acute lead connected to external neurostimulator in Parkinson's Disease and Essential Tremor, sponsored by Aleva Neurotherapeutics SA. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by Aleva Neurotherapeutics SA · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson's Disease
  • Essential Tremor
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 13 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Aleva Neurotherapeutics SA is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Directional lead

    Device: directSTN Acute lead connected to external neurostimulator

Interventions

  • DevicedirectSTN Acute lead connected to external neurostimulator

    Test phase will be performed intra-operatively, prior to chronic lead implant

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to one hour during surgery

Secondary outcomes

  1. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Inselspital University Hospital
    Bern, 3030, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01764815
Lead sponsor
Aleva Neurotherapeutics SA
Responsible party
Sponsor
First posted
Jan 10, 2013
Start date
Dec 2012
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Jul 2, 2017

Study contacts

Claudio Pollo, PD, Dr. med
principal investigator · Inselspital, Bern University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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