Relief From Side Effects: Clinical Use of Electrodes With Direction

NCT03795935 | Unknown

• 1 other identifier: H17-00672
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Deep Brain Stimulation; Directional Lead; Essential Tremor

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed once all tests performed - 1 to 2 months post-operatively

Secondary Outcomes (3)

• Quality of life based on participant's best real life setting

  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 based on tremor management participant's best real life setting

  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 based on voice handicap with participant's best real life setting

  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

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

No side-effect stimulator settings with directional lead 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.

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

The Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E3, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 21096152 BACKGROUND

• 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.

  PMID: 28385887 BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Christopher Honey, DPhil

CONTACT

6048755894; chris.honey@telus.net

Natasha Sarai, BSN

CONTACT

6048754111; natasha.sarai@vch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: January 8, 2019
• Study Start: September 17, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)