NCT04116177

Brief Summary

Exploring the benefits of the linear lead in deep brain stimulation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

September 25, 2019

Last Update Submit

October 8, 2019

Conditions

Parkinson Disease

Keywords

Deep brain stimulationParkinson diseaseNovel strategies

Outcome Measures

Primary Outcomes (1)

  • Change of Overall Global functioning (PGIC)

    The PGIC evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status relative to baseline. This is a seven point scale with lower values indicating worsening and higher values, improvement.

    After 3 months of each intervention

Secondary Outcomes (9)

  • Measure of Quality of life (PDQ-39)

    After 3 months of each intervention

  • Clinical change in motor symptoms using Unified Parkinson Disease Rating Scale I-IV

    After 3 months of each intervention

  • Clinical change in motor symptoms

    After 3 months of each intervention

  • Number of falls

    After 3 months of each intervention

  • Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI)

    After 3 months of each intervention

  • +4 more secondary outcomes

Study Arms (2)

Standard Stimulation

ACTIVE COMPARATOR

Standard stimulation using contact 3-6 to achieve best therapeutic stimulation

Device: Deep brain stimulation

Flexible stimulation

EXPERIMENTAL

Flexible stimulation using all available stimulation strategies provided by the VerciseTM system including stimulation of contacts 1-8 and variable pulse width and frequency.

Device: Deep brain stimulation

Interventions

Deep brain stimulationDEVICE

Stimulation using VerciseTM system

Flexible stimulationStandard Stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Patients with a diagnosis of PD according to the British Parkinson's Disease Society

You may not qualify if:

  • Male and female patients with idiopathic PD, who have symptoms responsive to L-dopa medications, but who have significant impairment related to PD that is no longer well controlled with pharmacotherapy (i.e., refractory to optimized medical therapy)
  • Patients considered as STN-DBS candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
  • Quality of life and social functioning influenced by levodopa-responsive signs
  • No major comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Movement disorders Centre, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (9)

  • Fasano A, Daniele A, Albanese A. Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Lancet Neurol. 2012 May;11(5):429-42. doi: 10.1016/S1474-4422(12)70049-2.

    PMID: 22516078BACKGROUND

  • Herzog J, Pinsker M, Wasner M, Steigerwald F, Wailke S, Deuschl G, Volkmann J. Stimulation of subthalamic fibre tracts reduces dyskinesias in STN-DBS. Mov Disord. 2007 Apr 15;22(5):679-84. doi: 10.1002/mds.21387.

    PMID: 17266046BACKGROUND

  • Herzog J, Hamel W, Wenzelburger R, Potter M, Pinsker MO, Bartussek J, Morsnowski A, Steigerwald F, Deuschl G, Volkmann J. Kinematic analysis of thalamic versus subthalamic neurostimulation in postural and intention tremor. Brain. 2007 Jun;130(Pt 6):1608-25. doi: 10.1093/brain/awm077. Epub 2007 Apr 17.

    PMID: 17439979BACKGROUND

  • Chastan N, Westby GW, Yelnik J, Bardinet E, Do MC, Agid Y, Welter ML. Effects of nigral stimulation on locomotion and postural stability in patients with Parkinson's disease. Brain. 2009 Jan;132(Pt 1):172-84. doi: 10.1093/brain/awn294. Epub 2008 Nov 11.

    PMID: 19001482BACKGROUND

  • Weiss D, Walach M, Meisner C, Fritz M, Scholten M, Breit S, Plewnia C, Bender B, Gharabaghi A, Wachter T, Kruger R. Nigral stimulation for resistant axial motor impairment in Parkinson's disease? A randomized controlled trial. Brain. 2013 Jul;136(Pt 7):2098-108. doi: 10.1093/brain/awt122. Epub 2013 Jun 11.

    PMID: 23757762BACKGROUND

  • Barbe MT, Maarouf M, Alesch F, Timmermann L. Multiple source current steering--a novel deep brain stimulation concept for customized programming in a Parkinson's disease patient. Parkinsonism Relat Disord. 2014 Apr;20(4):471-3. doi: 10.1016/j.parkreldis.2013.07.021. Epub 2013 Sep 14. No abstract available.

    PMID: 24041939BACKGROUND

  • Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.

    PMID: 6067254BACKGROUND

  • Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.

    PMID: 9351479BACKGROUND

  • Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.

    PMID: 26027940BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2019

First Posted

October 4, 2019

Study Start

September 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)