Spinal Cord Stimulation for Gait in Parkinson Disease
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ClinicalTrials.gov Identifier: NCT03079310 |
Recruitment Status : Unknown
Verified June 2020 by Western University, Canada.
Recruitment status was: Recruiting
First Posted : March 14, 2017
Last Update Posted : June 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease Atypical Parkinsonism | Device: Spinal cord stimulation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Thoracic Dorsal Spinal Cord Stimulation for the Treatment of Gait and Balance Impairments in Parkinson Disease |
Actual Study Start Date : | February 2016 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Spinal cord stimulation
Boston Scientific SCS system
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Device: Spinal cord stimulation
Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient
Other Name: Boston Scientific Precision® System |
- Tailored SCS programming [ Time Frame: 3 weeks ]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.
- Changes in spatiotemporal gait measures using objective gait analysis [ Time Frame: 12 months ]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.
- Changes in UPDRS-III scores [ Time Frame: 12 months ]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.
- Changes in NFOG-Q scores [ Time Frame: 12 months ]NFOG-Q scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
- Changes in PDQ-39 scores [ Time Frame: 12 months ]PDQ-39 scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
- Changes in ABC scores [ Time Frame: 12 months ]ABC scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
- Changes in QoL scores [ Time Frame: 12 months ]QoL scores will be assessed pre-surgery and post-surgery at 3-, 6- and 12-month time-points.
- DaTscan imaging [ Time Frame: 12-months ]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.
- Proprioception testing [ Time Frame: 12-months ]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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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).
Exclusion Criteria:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079310
Contact: Mandar Jog, MD | 519-685-8500 ext 76708 | ||
Contact: Olivia Samotus, MSc | 519-685-8500 ext 32059 |
Canada, Ontario | |
London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A5A5 | |
Contact: Mandar Jog, MD 519-685-8500 ext 32758 mandar.jog@lhsc.on.ca |
Principal Investigator: | Mandar Jog, MD | LHSC |
Responsible Party: | Western University, Canada |
ClinicalTrials.gov Identifier: | NCT03079310 |
Other Study ID Numbers: |
107451 |
First Posted: | March 14, 2017 Key Record Dates |
Last Update Posted: | June 23, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
spinal cord stimulation gait analysis whole-body kinematics |
Parkinson's disease Neuromodulation Feature extraction |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |