Recruiting

Spinal Cord Stimulation

Sponsor:

Western University, Canada

Code:

NCT03079310

Conditions

Parkinson Disease

Atypical Parkinsonism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Spinal cord stimulation

Study Details

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

Study ID

NCT03079310

Start date

Feb, 2016

Status verified date

Jun, 2020

Completion date

Apr, 2022

Anticipated

Primary completion date

Apr, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spinal cord stimulation

Boston Scientific SCS system

Interventions

Spinal cord stimulation

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

Primary outcome measure

  • Tailored SCS programming [ Time Frame: 3 weeks ]
  • Changes in spatiotemporal gait measures using objective gait analysis [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Mandar Jog, MD

519-685-8500

Olivia Samotus, MSc

519-685-8500

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

Mandar Jog, MD

519-685-8500mandar.jog@lhsc.on.ca

More Information

Sponsor

Western University, Canada

Last update posted

Jun 23, 2020

Last verified

Jun, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2020-06-23.