Clinical trial NCT03795935: Relief From Side Effects: Clinical Use of Electrodes With Direction
Official title: Relief From Side Effects: Clinical Use of Electrodes With Direction: a Prospective, Open Label, Clinical Trial for Thalamic Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Brain Stimulation
Directional Lead
Essential Tremor
Keywords: Deep Brain Stimulation
Directional Lead
Essential Tremor
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2019-01-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Deep Brain Stimulation (DBS) uses electrical pulses sent through a lead (insulated wire) to help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in patients with Essential Tremor (ET). The current standard lead allows this stimulation to spread out uniformly in all directions. As these diseases progress, however, the amount of electrical stimulation required to stop the symptom usually increases. This may become problematic because the increased electrical stimulation required for advanced symptoms may spread outside the desired targeted area, and effect other parts of the brain and causing unwanted side effects. A new type of DBS lead has been developed which can steer, or focus, the electrical stimulation in a given direction toward the desired target area and away from areas that would cause side effects. We would like to quantify the benefit seen in patients who have been switched from the traditional lead to this new directional lead.

Detailed description: Patients implanted with a DBS may experience unwanted side effects such as motor contractures, paresthesia, or dysarthria. This occurs when the electrical field of the stimulation spreads out beyond the targeted area. This is especially common in patients whose disease has progressed, and must use increasingly higher currents in order to regain control of their tremor. Unfortunately, because the electrical field affects neurons in a symmetrical sphere around the DBS, it is often impossible to reach the additional desired neuronal elements without simultaneously affecting equidistant brain regions responsible for side effects. For many of our advanced patients, this means choosing between a debilitating tremor or disabling side effects.The directional lead is a FDA and Health Canada approved DBS lead which features radially segmented electrodes which can selectively steer the electrical field in a predefined direction, orthogonal to the lead trajectory. This will allow DBS clinicians to steer current towards desired structural areas, while avoiding locations, which produce negative side effects.

Eligibility criteria: Inclusion Criteria:

* Participants must have been implanted with the DBS
* Participants must have been diagnosed with Essential Tremor
* Participants must experience negative side effects from their DBS which limit control over their tremor
* Participants must be able to receive benefit from their stimulator, but at the cost of negative side effects

Exclusion Criteria:

* All individuals who meet criteria outlined in "inclusion criteria" may be eligible for this study

Primary outcomes:
measure: Tremor Control
timeFrame: Assessed once all tests performed - 1 to 2 months post-operatively
Secondary outcomes:
measure: Quality of life based on participant's best real life setting
timeFrame: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
measure: Quality of life based on tremor management participant's best real life setting
timeFrame: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
measure: Quality of life based on voice handicap with participant's best real life setting
timeFrame: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Vancouver General Hospital
state: British Columbia
Study officials:
References:
citation: Toader E, Decre MM, Martens HC. Steering deep brain stimulation fields using a high resolution electrode array. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2061-4. doi: 10.1109/IEMBS.2010.5626472.
citation: Reinacher PC, Kruger MT, Coenen VA, Shah M, Roelz R, Jenkner C, Egger K. Determining the Orientation of Directional Deep Brain Stimulation Electrodes Using 3D Rotational Fluoroscopy. AJNR Am J Neuroradiol. 2017 Jun;38(6):1111-1116. doi: 10.3174/ajnr.A5153. Epub 2017 Apr 6.