Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795935
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Christopher Honey, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Deep Brain Stimulation Directional Lead Essential Tremor Other: No side-effect stimulator settings with directional lead Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Relief From Side Effects: Clinical Use of Electrodes With Direction: a Prospective, Open Label, Clinical Trial for Thalamic Deep Brain Stimulation
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
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
Other: 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 Measures :
  1. Tremor Control [ Time Frame: Assessed once all tests performed - 1 to 2 months post-operatively ]
    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 :
  1. Quality of life based on participant's best real life setting [ 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 ]
    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.

  2. Quality of life based on tremor management participant's best real life setting [ 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 ]
    Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare.

  3. Quality of life based on voice handicap with participant's best real life setting [ 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 ]
    Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795935


Contacts
Layout table for location contacts
Contact: Christopher Honey, DPhil 6048755894 chris.honey@telus.net
Contact: Natasha Sarai, BSN 6048754111 ext 69584 natasha.sarai@vch.ca

Locations
Layout table for location information
Canada, British Columbia
The Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 4E3
Contact: Christopher R Honey, MD, DPhil    604.875.5894    chris.honey@telus.net   
Sponsors and Collaborators
University of British Columbia
Boston Scientific Corporation
Publications:
Layout table for additonal information
Responsible Party: Christopher Honey, Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders, University of British Columbia
ClinicalTrials.gov Identifier: NCT03795935    
Other Study ID Numbers: H17-00672
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher Honey, University of British Columbia:
Deep Brain Stimulation
Directional Lead
Essential Tremor
Additional relevant MeSH terms:
Layout table for MeSH terms
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases