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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02388204
Acronym
SCSPD
Enrollment
20
Registered
2015-03-13
Start date
2014-06-30
Completion date
2017-12-31
Last updated
2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Gait, Locomotion, Freezing

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.

Interventions

PROCEDUREImplantable spinal cord stimulation

Implantation of SCS electrode and pulse generator

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in locomotion capacity6 monthsTimed-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

MeasureTime frameDescription
Changes in freezing of Gait6 monthsFOG (freezing of gait scale): difference between scores pre-implantation and 6 months after stimulation initiation
Changes in quality of life6 monthsParkinson Disease Questionnaire 39: difference between scores pre-implantation and 6 months after stimulation initiation
Motor changes6 monthsUnified Parkinson's Disease Rating Scale motor score: difference between scores pre-implantation and 6 months after stimulation initiation

Countries

Brazil

Contacts

Primary ContactErich T Fonoff, MD/PhD/Prof
fonoffet@usp.br5511983268848/551126616402
Backup ContactCarolina P de Souza, MD
carolinasouza@usp.br5516 33297315/551633297317

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026