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Completed

NCT Number: NCT01764815

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Essential Tremor Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital University Hospital

Bern, 3030, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

directSTN Acute lead connected to external neurostimulator

Device

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

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.

    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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Aleva Neurotherapeutics SA

Industry

Registry information

Official study title

Evaluation of Directional Stimulation During the Implantation of Deep Brain Stimulation Leads for the Treatment of Movement Disorders

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 10, 2013
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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