NCT02894567

Evaluation of Directional Recording and Stimulation Using spiderSTN

Evaluation of Directional Recording and Stimulation Using the spiderSTN During the Implantation of DBS Leads

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Aleva Neurotherapeutics SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide proof-of-concept that directional stimulation and directional recording, in an intraoperative setting, is perceivable in a subject. The tests will be performed using a dedicated intraoperative lead connected to an external neuro-recorder/stimulator, during a deep brain stimulation implantation surgery.

Detailed description

Deep brain stimulation (DBS) technique involves implanting electrodes using a stereotactic method and connecting them to a pulse generator to deliver a current in localized areas in the brain. The optimum location for DBS electrodes is determined by pre-operative brain imaging, often combined with an intraoperative microelectrode recording/stimulating (MER) sequence. Current MER practice involves inserting micro-recording/stimulating electrodes into guide tubes in the brain and lowering them towards the target, performing recordings at selected steps. The recordings differ based on the types of neuronal structures they are passing through.Based on the recordings, some promising locations are further discriminated by stimulation using macro-electrodes, and the target for final lead placement is chosen. The spiderSTN lead (Aleva Neurotherapeutics SA, Switzerland) is capable of recording and stimulating from both its inner and outer surface, allowing the user to steer the direction of stimulation during the target location phase. This will allow the neurosurgeon greater flexibility in investigating the balance between therapeutic benefits and stimulation-induced side effects at a given location. This feasibility study is designed to explore the effect of directional stimulation and the ability to differentiate between stimulation induced side effects at a given location, during the DBS surgery. It will be proposed to patients who suffer from Parkinson disease (PD) or essential tremor (ET) and for whom DBS is indicated according to standard criteria at the hospital. It will be restricted to a limited number of patients (10), sufficient to assess the recording and stimulating capacity of the spiderSTN device. The patient undergoes the normal DBS surgery until the position for the final lead has been chosen. Then the spiderSTN test phase takes place. Once test phase is completed, the conventional DBS surgery resumes.

Conditions

• Parkinson's Disease
• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Intraoperative test during a deep brain stimulation surgery	The spiderSTN lead is inserted in a selected track in the brain, and is connected to external neuro-recorder/stimulator . Once the intraoperative test phase is completed, the test devices are removed and the DBS surgery resumes.

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-09-09
• Last updated: 2017-07-02

Locations

1 site across 1 country: Switzerland