An interventional study of Deep brain stimulation in Parkinson Disease, sponsored by University of Toronto. Status unknown at 2 sites in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-10.
Sponsored by University of Toronto · Not applicable, Interventional, and Treatment
Exploring the benefits of the linear lead in deep brain stimulation.
Detailed Description:
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:
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.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Toronto is the lead sponsor of 403 studies on the registry; 57 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1) Patients with a diagnosis of PD according to the British Parkinson's Disease Society
Exclusion Criteria:
1) Exclusion criteria will include patients with other significant neurologic or psychiatric illnesses or cognitive deficit.
Standard stimulation using contact 3-6 to achieve best therapeutic stimulation
Device: Deep brain 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.
Device: Deep brain stimulation
Stimulation using VerciseTM system
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.
Time frame: After 3 months of each intervention
Measure of Quality of life (PDQ-39)
The PDQ-39 assesses individuals experiences across 8 dimensions of daily living. Each dimension is scored from 0 to 100. Lower scores mean better quality of life.
Time frame: After 3 months of each intervention
Clinical change in motor symptoms using Unified Parkinson Disease Rating Scale I-IV
The Unified Parkinson Disease Rating Scale I-IV ranges from 0-199, with higher scores meaning more severe disease
Time frame: After 3 months of each intervention
Clinical change in motor symptoms
Clinical change in motor symptoms as measured using falls diaries
Time frame: After 3 months of each intervention
Number of falls
Using a falls diary
Time frame: After 3 months of each intervention
Change in the presence and severity of depressive symptoms using the Beck Depression Inventory (BDI)
The BDI is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Scores range from 0 to 63, with higher scores meaning worse depression.
Time frame: After 3 months of each intervention
Walking speed measure using Prokinetics gait analysis/Zeno Walkway
The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Walking speed will be measured.
Time frame: After 3 months of each intervention
Step length measured using Prokinetics gait analysis/Zeno Walkway
The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of step length will be measured.
Time frame: After 3 months of each intervention
Cadence measured using Prokinetics gait analysis/Zeno Walkway
The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of cadence will be measured. Cadence is the number of steps per minute of walking.
Time frame: After 3 months of each intervention
Double support time measured using Prokinetics gait analysis/Zeno Walkway
The Zeno Walkway is a 20 feet walking mat containing 16-pressure sensing pads and circuitry that allows for measurement of various gait and balance variables during straight walking. Patients will be asked to walk on the mat at a self selected pace. Mean and coefficients of variation (standard deviation divided by the mean x 100) of double support time will be measured. The double support time is the the time during gait where both feet are in contact to the ground
Time frame: After 3 months of each intervention
Plan to share: No
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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