Clinical trial NCT03079310: Spinal Cord Stimulation for Gait in Parkinson Disease
Official title: Thoracic Dorsal Spinal Cord Stimulation for the Treatment of Gait and Balance Impairments in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Atypical Parkinsonism
Keywords: spinal cord stimulation
gait analysis
whole-body kinematics
Parkinson's disease
Neuromodulation
Feature extraction
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tailored SCS programming
timeFrame: 3 weeks
measure: Changes in spatiotemporal gait measures using objective gait analysis
timeFrame: 12 months
Secondary outcomes:
measure: Changes in UPDRS-III scores
timeFrame: 12 months
measure: Changes in NFOG-Q scores
timeFrame: 12 months
measure: Changes in PDQ-39 scores
timeFrame: 12 months
measure: Changes in ABC scores
timeFrame: 12 months
measure: Changes in QoL scores
timeFrame: 12 months
measure: DaTscan imaging
timeFrame: 12-months
measure: Proprioception testing
timeFrame: 12-months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: LHSC
name: Mandar Jog, MD
role: PRINCIPAL_INVESTIGATOR
References:
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