NCT01764815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

December 26, 2012

Last Update Submit

June 30, 2017

Conditions

Parkinson's DiseaseEssential Tremor

Outcome Measures

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.

    up to one hour during surgery

Secondary Outcomes (1)

  • Electrical functionality of the study device during the test phase

    1 day

Study Arms (1)

Directional lead

EXPERIMENTAL
Device: directSTN Acute lead connected to external neurostimulator

Interventions

directSTN Acute lead connected to external neurostimulatorDEVICE

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

Directional lead

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital University Hospital

Bern, 3030, Switzerland

Location

MeSH Terms

Conditions

Parkinson DiseaseEssential Tremor

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Claudio Pollo, PD, Dr. med

    Inselspital, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2012

First Posted

January 10, 2013

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

CH(1)