Spinal Cord Stimulation for Gait in Parkinson Disease

NCT03079310 | Unknown

• 1 other identifier: 107451
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Atypical Parkinsonism

Keywords

spinal cord stimulation; gait analysis; whole-body kinematics; Parkinson's disease; Neuromodulation; Feature extraction

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Changes in UPDRS-III scores

  12 months

• Changes in NFOG-Q scores

  12 months

• Changes in PDQ-39 scores

  12 months

• Changes in ABC scores

  12 months

• Changes in QoL scores

  12 months

Study Arms (1)

Spinal cord stimulation

EXPERIMENTAL

Boston Scientific SCS system

Device: Spinal cord stimulation

Interventions

Spinal cord stimulation DEVICE

Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient

Also known as: Boston Scientific Precision® System

Spinal cord stimulation

Eligibility Criteria

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

You may qualify if:

• 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).
• we had a few devices to include exploratory trial in atypical PD (MSA, PSP, and CBD confirmed diagnosis from clinic).

You may not qualify if:

• History of stroke
• History of ALS or Myasthenia Gravis
• Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol).
• Persons prescribed zonisamide
• Women reporting that they are pregnant
• Persons medically unstable with contraindications to SCS will be excluded
• Previous brain surgery or cardiac pacemaker
• Eligibility for deep brain stimulation surgery
• Moderately severe parkinsonism in the context of unstable pharmacological treatment
• Dementia as assessed by DSM criteria or severe cognitive disturbances
• Severe psychiatric symptoms (in particular, hallucinations and depression)
• Bad general health
• Lack of compliance at follow-up
• Severe dyskinesias
• Significant cognitive impairment

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

RECRUITING

Related Publications (14)

• 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.

  PMID: 21039949 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.

  PMID: 25447740 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.

  PMID: 19097193 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.

  PMID: 19131039 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.

  PMID: 25932301 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.

  PMID: 17251240 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.

  PMID: 19773356 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.

  PMID: 24132835 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.

  PMID: 19299613 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.

  PMID: 21865071 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.

  PMID: 23453160 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.

  PMID: 22850494 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.

  PMID: 23227965 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.

  PMID: 24452435 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mandar Jog, MD

  LHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandar Jog, MD

CONTACT

519-685-8500

Olivia Samotus, MSc

CONTACT

519-685-8500

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 14, 2017
• Study Start: February 1, 2016
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)