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Parkinson DiseaseNCT03079310

Spinal Cord Stimulation for Gait in Parkinson Disease

A study testing Spinal cord stimulation in people with Parkinson Disease and Atypical Parkinsonism, run by Western University, Canada at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease, Atypical Parkinsonism
What is being tested?
Spinal cord stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteCanada
Study dates
Feb 2016to Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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).

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mandar Jog, MD contact

519-685-8500 ext. 76708

Olivia Samotus, MSc contact

519-685-8500 ext. 32059

Canada1 site, 1 recruiting

  • London Health Sciences Centre

    London, Ontario, N6A5A5

    Mandar Jog, MD, 519-685-8500 ext. 32758, mandar.jog@lhsc.on.ca

    Recruiting

Other trials in Canada

About this study

Official title: Thoracic Dorsal Spinal Cord Stimulation for the Treatment of Gait and Balance Impairments in Parkinson Disease

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.

Being tested
Spinal cord stimulation
Keywords
spinal cord stimulation, gait analysis, whole-body kinematics, Parkinson's disease, Neuromodulation, Feature extraction
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal cord stimulationDevice

    Also called Boston Scientific Precision® System

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

Study groups in NCT03079310
Study groupRoleWhat they receive
Spinal cord stimulationExperimentalBoston Scientific SCS system
Receives: Device: Spinal cord stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 weeks

  2. 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.

    Measured: 12 months

Secondary outcomes (7)

  1. 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.

    Measured: 12 months

  2. Changes in NFOG-Q scores

    NFOG-Q scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.

    Measured: 12 months

  3. Changes in PDQ-39 scores

    PDQ-39 scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.

    Measured: 12 months

  4. Changes in ABC scores

    ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.

    Measured: 12 months

  5. Changes in QoL scores

    QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.

    Measured: 12 months

  6. 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.

    Measured: 12-months

  7. 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

    Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study startFeb 2016
  3. Primary completionApr 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079310
Sponsor's protocol ID
107451
Status last verified
Jun 2020
First submitted
8 Mar 2017
Last updated
23 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21039949

  • 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.

    PubMed 25447740

  • 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.

    PubMed 19097193

  • 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.

    PubMed 19131039

  • 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.

    PubMed 25932301

  • 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.

    PubMed 17251240

  • 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.

    PubMed 19773356

  • 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.

    PubMed 24132835

  • 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.

    PubMed 19299613

  • 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.

    PubMed 21865071

  • 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.

    PubMed 23453160

  • 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.

    PubMed 22850494

  • 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.

    PubMed 23227965

  • 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.

    PubMed 24452435

Questions about this trial

What is this clinical trial studying?

A study testing Spinal cord stimulation in people with Parkinson Disease and Atypical Parkinsonism, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mandar Jog, MD (519-685-8500 ext. 76708), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tailored SCS programming (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03079310, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.

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