Flexible vs. Standard Deep Brain Stimulation Programming in Parkinson Disease Patients
NCT ID: NCT04116177
Last Updated: 2019-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2016-09-30
2020-06-30
Brief Summary
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Detailed Description
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This is a single-centre, double-blinded cross-over study comparing the 4 contact vs 8 contact electrodes of deep brain stimulation (DBS) patients.
The study will follow 2 phases.
Phase 1:
Visit 1 Screening/Baseline (T0):
As per current standard care for patients undergoing subthalamic deep brain stimulation (STN-DBS), participants will be screened 3-6 months before the surgery (T0) according to the inclusion/exclusion criteria.
Visits for standard programming of VerciseTM system between 1 to 3 months after the surgery of 10 patients will be done in an open label fashion in order to find the best program for optimization of patient motor symptoms without side effects. This will be done according to the standard of practice currently adopted at Toronto Western Hospital.
Phase 2:
Visit 1
Randomization: 4 months +/- 4weeks of the surgery, patients will be randomized to two type of stimulation:
1. Standard : only contacts 3-6 will be used in either unipolar or bipolar configuration; pulse width lower than 60μsec will not be used; all types of frequencies will be used but keeping the value constant for the both hemispheres at each active contact. The same amount of current for each of the active contacts will be used, however, in case of different currents at different contacts, an "interleaved" type of stimulation will be used and frequency will kept lower than 125Hz ( Fig 2A).
2. Flexible : contacts 1-8 will be used in any possible configuration and using different amount of current for each of the active one as well as different frequencies; pulse width lower than 60μsec can be used. In conclusion, all the capabilities of the VerciseTM system will be used. Possible adjustments to stimulation parameters (e.g. Pulse width, amplitude threshold) will be performed to achieve an optimal therapeutic window for each patient.
Visit 2
Follow up visit at 6 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 3 (T1):
Cross over : 7 months +/- 4 weeks after the surgery patients will be switched to the other type of stimulation . Raters and patients will be blinded to the group allocation.
Visit 4:
Follow up visit at 9 months +/- 4 weeks of the surgery for neurological examination if required.
Visit 5 (T2):
End of study visit at month 10 +/- 4 weeks after the surgery. Raters and patients will be blinded to the group allocation.
There might be unscheduled visits in case of unexpected clinical conditions (i.e. occurrence of side effects or worsening of motor conditions). Participants will be in this study for a maximum of 17 months. Throughout the whole study, participants will visit the clinic without their regular medication for PD as part of standard treatment practice. All the stimulation adjustment will be performed by the same unblinded physician using the GuideTM software provided by the company.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Standard Stimulation
Standard stimulation using contact 3-6 to achieve best therapeutic stimulation
Deep brain stimulation
Stimulation using VerciseTM system
Flexible stimulation
Flexible stimulation using all available stimulation strategies provided by the VerciseTM system including stimulation of contacts 1-8 and variable pulse width and frequency.
Deep brain stimulation
Stimulation using VerciseTM system
Interventions
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Deep brain stimulation
Stimulation using VerciseTM system
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3. Patients considered as STN-DBS candidates as per current standard of care. These patients will subsequently undergo STN-DBS surgery and maintain stimulation therapy.
4. Quality of life and social functioning influenced by levodopa-responsive signs
5. No major comorbidities
18 Years
80 Years
ALL
No
Sponsors
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University of Toronto
OTHER
Responsible Party
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Alfonso Fasano
Professor
Locations
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Movement disorders Centre, Toronto Western Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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15-9700
Identifier Type: -
Identifier Source: org_study_id
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