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

Aleva Neurotherapeutics

Status: Completed

Conditions: Essential Tremor; Parkinson's Disease

Treatments: Device: directSTN Acute lead connected to external neurostimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764815

CIV-12-08-008482 (Other Identifier)

KEK 072-12

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Directional lead

Experimental group

Treatment:

Device: directSTN Acute lead connected to external neurostimulator