Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease

Not Applicable

• Conditions: Parkinson's Disease
• Interventions: Procedure: Implantable spinal cord stimulation

• Registration Number: NCT02388204
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2014-06
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study First Submitted: 2015-03-08
• Study First Submitted QC: 2015-03-08
• Last Update Submitted: 2015-03-12
• Study First Posted: 2015-03-13
• Last Update Posted: 2015-03-17
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson's disease patients	Implantable spinal cord stimulation	Group description: PD patients with locomotion problems as the primary complain with no interventions other than medication and rehabilitation therapies Intervention: Implantable spinal cord stimulation.
DBS Parkinson's disease patients	Implantable spinal cord stimulation	Group description: PD patients with locomotion problems as the primary complain after cardinal symptoms are controlled by DBS. Intervention: Implantable spinal cord stimulation.

Primary Outcome Measures

Name	Time	Method
Changes in locomotion capacity	6 months	"Timed-up-go" test : time to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation "20 meters walking test": time and steps numbers to complete the test "20 meters walking test- with obstacles": time and steps numbers to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation "Dual task Timed-up-go" test : time to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation "Dual task Timed-up-go" test : time to complete the test : difference between scores pre-implantation and 6 months after stimulation initiation

Secondary Outcome Measures

Name	Time	Method
Changes in freezing of Gait	6 months	FOG (freezing of gait scale): difference between scores pre-implantation and 6 months after stimulation initiation
Changes in quality of life	6 months	Parkinson Disease Questionnaire 39: difference between scores pre-implantation and 6 months after stimulation initiation
Motor changes	6 months	Unified Parkinson's Disease Rating Scale motor score: difference between scores pre-implantation and 6 months after stimulation initiation

Trial Locations

Locations (1)

Division of Functional Neurosurgery; 🇧🇷 São Paulo, Brazil