Recruiting

Electrodes With Direction

Sponsor:

University of British Columbia

Code:

NCT03795935

Conditions

Deep Brain Stimulation

Directional Lead

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

No side-effect stimulator settings with directional lead

Study Details

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.

Conditions

Deep Brain Stimulation

Directional Lead

Essential Tremor

Study ID

NCT03795935

Start date

Sep 17, 2018

Status verified date

Jan, 2019

Completion date

Aug 1, 2019

Anticipated

Primary completion date

Jul 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

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.

Primary outcome measure

  • Tremor Control [ Time Frame: Assessed once all tests performed - 1 to 2 months post-operatively ]

Central Contacts and Locations

Central contacts

Christopher Honey, DPhil

6048755894chris.honey@telus.net

Natasha Sarai, BSN

6048754111natasha.sarai@vch.ca

Locations

The Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E3

Contacts

Christopher R Honey, MD, DPhil

604.875.5894chris.honey@telus.net

More Information

Sponsor

University of British Columbia

Last update posted

Jan 8, 2019

Last verified

Jan, 2019

Keywords

  • Deep Brain Stimulation
  • Directional Lead
  • Essential Tremor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2019-01-08.