Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Balance and gait impairment increases the risk of falls and contributes to a reduced quality of life and shorter survival in Parkinson disease (PD) and atypical Parkinsonism patients. In preliminary case studies, electrical epidural spinal cord stimulation (SCS) has been shown to significantly improve gait, postural instability, rigidity, and tremor. Controlled studies for optimizing which stimulation settings produce the best clinical response for mobility and gait, and achieving these results chronically are all significant unmet needs. Using quantitative laboratory and mobile technologies to test a range of stimulation settings, this research study aims to determine which SCS parameters or combination of parameters is best suited to effectively alleviate disabling symptoms experienced by each patient.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord stimulation | Experimental | Boston Scientific SCS system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal cord stimulation | Device | Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tailored SCS programming | Participants following SCS implantation will undergo 3 programming visits. 9 SCS programs will be tested in a repeated fashion on separate days and at different times of the day (morning vs afternoon). The SCS setting(s) to produce the best motor (gait) response will be used by the participant in-home. SCS device will not be used during this time period. | 3 weeks |
| Changes in spatiotemporal gait measures using objective gait analysis | Spatiotemporal gait parameters known to be affected in parkinsonian syndromes will be analyzed over a 12 month period using gait analysis software. Best SCS setting tailored to each participant's gait symptoms will be assessed at 3-, 6- and 12-months time-points. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in UPDRS-III scores | UPDRS-III assessment will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points while participants are OFF/ON-dopaminergic medication and OFF/ON SCS. | 12 months |
| Changes in NFOG-Q scores |
Not provided
Inclusion Criteria:
Consenting male and female participants, aged 18 years to 80 years
Idiopathic PD with II-IV Hoehn-Yahn stage
A history of frequent falls, gait and balance dysfunction and postural instability
ON-freezing
Ability to perform a gait/walking task (under close supervision),
PD participants referred by Dr. Jog to the functional neurosurgeon for SCS implantation for treatment of their gait and balance dysfunction and/or for their freezing of gait.
SCS eligibility has been confirmed by neurologist and neurosurgeon
Patients who receive SCS for their gait and mobility must participate in this study in order to determine which SCS parameters provide the patient with the best outcome for their PD symptoms.
able to give informed consent
Able to attend all clinic visits and assessments
No dementia or psychiatric abnormalities on neuropsychological testing
No significant secondary causes (such as cerebrovascular disease, normal pressure hydrocephalus, peripheral neuropathy, severe degenerative lower limb or back disease).
Exclusion Criteria:
History of stroke
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mandar Jog, MD | Contact | 519-685-8500 | 76708 | |
| Olivia Samotus, MSc | Contact | 519-685-8500 | 32059 |
| Name | Affiliation | Role |
|---|---|---|
| Mandar Jog, MD | LHSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | Recruiting | London | Ontario | N6A5A5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21039949 | Background | Fuentes R, Petersson P, Nicolelis MA. Restoration of locomotive function in Parkinson's disease by spinal cord stimulation: mechanistic approach. Eur J Neurosci. 2010 Oct;32(7):1100-8. doi: 10.1111/j.1460-9568.2010.07417.x. | |
| 25447740 | Background | Santana MB, Halje P, Simplicio H, Richter U, Freire MAM, Petersson P, Fuentes R, Nicolelis MAL. Spinal cord stimulation alleviates motor deficits in a primate model of Parkinson disease. Neuron. 2014 Nov 19;84(4):716-722. doi: 10.1016/j.neuron.2014.08.061. Epub 2014 Oct 30. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
NFOG-Q scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
| 12 months |
| Changes in PDQ-39 scores | PDQ-39 scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points. | 12 months |
| Changes in ABC scores | ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points. | 12 months |
| Changes in QoL scores | QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points. | 12 months |
| DaTscan imaging | Asymmetry and specific binding ratios (SBRs) of the striatal regions of dopamine transporter from I-123 FP-CIT SPECT images will be quantitatively analyzed from pre-surgery and 12-months of SCS use. | 12-months |
| Proprioception testing | KINARM and lower leg KINARM type of robot collects reaction time, speed, force, accuracy and trajectory using a robotic object hitting game to assess cognitive and motor skills to be conducted pre-surgery, and post-SCS at 3-, 6- and 12-months | 12-months |
| 19097193 | Background | Jenkinson N, Nandi D, Muthusamy K, Ray NJ, Gregory R, Stein JF, Aziz TZ. Anatomy, physiology, and pathophysiology of the pedunculopontine nucleus. Mov Disord. 2009 Feb 15;24(3):319-28. doi: 10.1002/mds.22189. |
| 19131039 | Background | Nagatsua T, Sawadab M. L-dopa therapy for Parkinson's disease: past, present, and future. Parkinsonism Relat Disord. 2009 Jan;15 Suppl 1:S3-8. doi: 10.1016/S1353-8020(09)70004-5. |
| 25932301 | Background | Liu HG, Zhang K, Yang AC, Zhang JG. Deep brain stimulation of the subthalamic and pedunculopontine nucleus in a patient with Parkinson's disease. J Korean Neurosurg Soc. 2015 Apr;57(4):303-6. doi: 10.3340/jkns.2015.57.4.303. Epub 2015 Apr 24. |
| 17251240 | Background | Stefani A, Lozano AM, Peppe A, Stanzione P, Galati S, Tropepi D, Pierantozzi M, Brusa L, Scarnati E, Mazzone P. Bilateral deep brain stimulation of the pedunculopontine and subthalamic nuclei in severe Parkinson's disease. Brain. 2007 Jun;130(Pt 6):1596-607. doi: 10.1093/brain/awl346. Epub 2007 Jan 24. |
| 19773356 | Background | Ferraye MU, Debu B, Fraix V, Goetz L, Ardouin C, Yelnik J, Henry-Lagrange C, Seigneuret E, Piallat B, Krack P, Le Bas JF, Benabid AL, Chabardes S, Pollak P. Effects of pedunculopontine nucleus area stimulation on gait disorders in Parkinson's disease. Brain. 2010 Jan;133(Pt 1):205-14. doi: 10.1093/brain/awp229. Epub 2009 Sep 22. |
| 24132835 | Background | Giladi N, Horak FB, Hausdorff JM. Classification of gait disturbances: distinguishing between continuous and episodic changes. Mov Disord. 2013 Sep 15;28(11):1469-73. doi: 10.1002/mds.25672. |
| 19299613 | Background | Fuentes R, Petersson P, Siesser WB, Caron MG, Nicolelis MA. Spinal cord stimulation restores locomotion in animal models of Parkinson's disease. Science. 2009 Mar 20;323(5921):1578-82. doi: 10.1126/science.1164901. |
| 21865071 | Background | Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available. |
| 23453160 | Background | Hassan S, Amer S, Alwaki A, Elborno A. A patient with Parkinson's disease benefits from spinal cord stimulation. J Clin Neurosci. 2013 Aug;20(8):1155-6. doi: 10.1016/j.jocn.2012.08.018. Epub 2013 Feb 26. |
| 22850494 | Background | Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470. |
| 23227965 | Background | Landi A, Trezza A, Pirillo D, Vimercati A, Antonini A, Sganzerla EP. Spinal cord stimulation for the treatment of sensory symptoms in advanced Parkinson's disease. Neuromodulation. 2013 May-Jun;16(3):276-9. doi: 10.1111/ner.12005. Epub 2012 Dec 10. No abstract available. |
| 24452435 | Background | Yadav AP, Fuentes R, Zhang H, Vinholo T, Wang CH, Freire MA, Nicolelis MA. Chronic spinal cord electrical stimulation protects against 6-hydroxydopamine lesions. Sci Rep. 2014 Jan 23;4:3839. doi: 10.1038/srep03839. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |