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Relief From Side Effects: Clinical Use of Electrodes With Direction (RESCUED)

Primary Purpose

Deep Brain Stimulation, Directional Lead, Essential Tremor

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No side-effect stimulator settings with directional lead
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Brain Stimulation focused on measuring Deep Brain Stimulation, Directional Lead, Essential Tremor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Tremor Control
Maximum percentage change in tremor (as measured by the Tremor Rating Scale) without side-effects (comparing DBS "on" versus "off") in each patient using the standard lead compared to the directional lead.

Secondary Outcome Measures

Quality of life based on participant's best real life setting
Quality of life will be based on each participant's subjective opinion using the Short Form 36 (SF36) (a patient-reported survey focusing on health and quality of life) assessment form.
Quality of life based on tremor management participant's best real life setting
Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare.
Quality of life based on voice handicap with participant's best real life setting
Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale.

Full Information

First Posted
September 17, 2018
Last Updated
January 6, 2019
Sponsor
University of British Columbia
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03795935
Brief Title
Relief From Side Effects: Clinical Use of Electrodes With Direction
Acronym
RESCUED
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Brain Stimulation, Directional Lead, Essential Tremor
Keywords
Deep Brain Stimulation, Directional Lead, Essential Tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
No side-effect stimulator settings with directional lead
Intervention Description
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 Information:
Title
Tremor Control
Description
Maximum percentage change in tremor (as measured by the Tremor Rating Scale) without side-effects (comparing DBS "on" versus "off") in each patient using the standard lead compared to the directional lead.
Time Frame
Assessed once all tests performed - 1 to 2 months post-operatively
Secondary Outcome Measure Information:
Title
Quality of life based on participant's best real life setting
Description
Quality of life will be based on each participant's subjective opinion using the Short Form 36 (SF36) (a patient-reported survey focusing on health and quality of life) assessment form.
Time Frame
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
Title
Quality of life based on tremor management participant's best real life setting
Description
Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare.
Time Frame
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
Title
Quality of life based on voice handicap with participant's best real life setting
Description
Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Honey, DPhil
Phone
6048755894
Email
chris.honey@telus.net
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Sarai, BSN
Phone
6048754111
Ext
69584
Email
natasha.sarai@vch.ca
Facility Information:
Facility Name
The Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher R Honey, MD, DPhil
Phone
604.875.5894
Email
chris.honey@telus.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21096152
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.
Results Reference
background
PubMed Identifier
28385887
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.
Results Reference
background

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Relief From Side Effects: Clinical Use of Electrodes With Direction

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