Clinical trial NCT02388204: Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease
Official title: Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Gait
Locomotion
Freezing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although DBS improves patient's quality of life advanced Parkinson's patients (PD) by addressing the cardinal symptoms and reducing levodopa motor complications, symptoms still worsen over time. Postural problems, frequent falls, freezing of gait impairment and other locomotion difficulties still remain as important causes of disability and incapacity. Novel therapeutics approaches are needed to restore quality of life (QoL).

This study aims to explore the effects of spinal cord stimulation in locomotion, falls and freezing of gait in advanced PD patients.

Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a prospective study for six months.

Changes in locomotion capacity and freezing of gait rating will be the primary out come. Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always comparing the status before, one, three and six months after stimulation was initiated. A double blind trial will be performed within three months of follow up (high X low frequency stimulation).

Detailed description: Background: Currently there are no available Parkinson's disease (PD) therapy can really stop disease progression. Although Deep Brain Stimulation (DBS) improves patient's quality of life by addressing the cardinal symptoms and reducing Levodopa motor complications, non motor symptoms still increasing over time. Gait problems as falls and freezing are important cause of disability and incapacity. Novel therapeutics approaches are needed to restore quality of life. Data from animal PD model suggest that spinal cord stimulation (SCS) can enhance locomotion in mice. Although clinical results, mostly from case reports, in PD patients are still conflicting, a few patients benefited from SCS in thoracic levels.

Aim: Evaluated Spinal cord stimulation effects in locomotion, gait, freezing and falls in PD patient's.

Method: 20 PD patients will undergo thoracic spinal cord stimulation with high frequency in a prospective study for six months. Gait and freezing evaluation will consists in: timed up and go test, timed up and go test with dual task, 20 m walk test, 20 m walk test with obstacle, freezing of gait scale and falls scale. PDQ 39 and Schwab and England scales will be used to measure quality of life. Unified Parkinson's Disease Rating Scale for motor symptoms and general evaluation. All tests will be done before surgery, after one week, one, three, six months. All patients will be stimulated with the same parameters: High frequencies and 90 mcs pulse width and the sensory threshold will be measured. At the third month the parameters of SCS will be changed and comparative tested for low frequency in a double blind trail.

Eligibility criteria: Inclusion Criteria:

1. Idiopathic PD
2. Gait and locomotion problems as the main complain/symptom
3. PD patients with or without DBS
4. Hoehn and Yahr scale equal or more than 2.0

Exclusion Criteria:

1. Dementia
2. Hoehn and Yahr scale more than 4
3. Less than 5 years of Parkinson's disease symptoms
4. General contraindications of surgery

Primary outcomes:
measure: Changes in locomotion capacity
timeFrame: 6 months
Secondary outcomes:
measure: Changes in freezing of Gait
timeFrame: 6 months
measure: Changes in quality of life
timeFrame: 6 months
measure: Motor changes
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Division of Functional Neurosurgery
Study officials:
affiliation: University of São Paulo, Department of Neurology
name: Erich T Fonoff, MD/PhD/Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Thevathasan W, Mazzone P, Jha A, Djamshidian A, Dileone M, Di Lazzaro V, Brown P. Spinal cord stimulation failed to relieve akinesia or restore locomotion in Parkinson disease. Neurology. 2010 Apr 20;74(16):1325-7. doi: 10.1212/WNL.0b013e3181d9ed58. No abstract available.