Relief From Side Effects: Clinical Use of Electrodes With Direction

NCT ID: NCT03795935

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-08-01

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.

Conditions

Deep Brain Stimulation; Directional Lead; Essential Tremor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients who were previously implanted with a traditional DBS lead and have subsequently developed stimulation induced side effects will gain significantly more tremor control without side effects when re-implanted with a directional DBS lead. We expect these patients' quality of life will improve. These patients typically will have had significant tremor relief (greater than 75% reduction from preoperative tremor rating scale) without side effects at their one year post operative follow-up. With the expected disease progression they will have had to increase their DBS stimulation to the degree that their DBS now causes side effects in order to block their tremor

Group Type: EXPERIMENTAL

No side-effect stimulator settings with directional lead

Intervention Type: OTHER

Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects.

Interventions

No side-effect stimulator settings with directional lead

Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Christopher Honey

Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Christopher Honey, DPhil

Role: CONTACT

chris.honey@telus.net

6048755894

Natasha Sarai, BSN

Role: CONTACT

natasha.sarai@vch.ca

6048754111 ext. 69584

Facility Contacts

Christopher R Honey, MD, DPhil

Role: primary

chris.honey@telus.net

604.875.5894

References

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.

Reference Type: BACKGROUND

PMID: 21096152 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28385887 (View on PubMed)

Other Identifiers

H17-00672

Identifier Type: -

Identifier Source: org_study_id