Parkinson's DiseaseSCSPDNCT02388204
Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease
A study testing Implantable spinal cord stimulation in people with Parkinson's Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Implantable spinal cord stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD
- Gait and locomotion problems as the main complain/symptom
- PD patients with or without DBS
- Hoehn and Yahr scale equal or more than 2.0
Who cannot join
- Dementia
- Hoehn and Yahr scale more than 4
- Less than 5 years of Parkinson's disease symptoms
- General contraindications of surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Division of Functional Neurosurgery
São Paulo, São Paulo, 01060-970
Erich T Fonoff, MD/PhD/Prof, 5511983238848, fonoffet@usp.br
Egberto R Barbosa, MD/PhD/Prof, 551126617152, egbertob@8415.com.br
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Implantable spinal cord stimulation
- Keywords
- Gait, Locomotion, Freezing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable spinal cord stimulationProcedure or surgery
Also called Implantable SCS electrode and IPG (Medtronic)
Implantation of SCS electrode and pulse generator
Implantable spinal cord stimulationProcedure or surgery
Also called Implantable SCS electrode and IPG (Medtronic)
Implantation of SCS electrode and pulse generator
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Experimental | 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. Receives: Procedure: Implantable spinal cord stimulation |
| DBS Parkinson's disease patients | Experimental | Group description: PD patients with locomotion problems as the primary complain after cardinal symptoms are controlled by DBS.
Intervention: Implantable spinal cord stimulation. Receives: Procedure: Implantable spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in locomotion capacity
"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
Measured: 6 months
Secondary outcomes (3)
Changes in freezing of Gait
FOG (freezing of gait scale): difference between scores pre-implantation and 6 months after stimulation initiation
Measured: 6 months
Changes in quality of life
Parkinson Disease Questionnaire 39: difference between scores pre-implantation and 6 months after stimulation initiation
Measured: 6 months
Motor changes
Unified Parkinson's Disease Rating Scale motor score: difference between scores pre-implantation and 6 months after stimulation initiation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionMar 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erich Talamoni Fonoff, University of Sao Paulo
- Investigators
- Erich T Fonoff, MD/PhD/Prof, Principal investigator, University of São Paulo, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388204
- Sponsor's protocol ID
- USaoPaulo1
- Acronym
- SCSPD
- Status last verified
- Mar 2015
- First submitted
- 8 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21039949Fuentes 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.
PubMed 19299613Agari 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.
PubMed 22850494Fenelon 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.
PubMed 21865071Hassan 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.
PubMed 23453160Landi 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.
PubMed 23227965Thevathasan 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.
PubMed 20404313
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02388204
- Acronym / sponsor ID
- SCSPD / USaoPaulo1
- Conditions
- Parkinson's Disease
- Keywords
- Gait, Locomotion, Freezing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | Experimental | Procedure: Implantable spinal cord stimulationGroup 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 | Experimental | Procedure: Implantable spinal cord stimulationGroup description: PD patients with locomotion problems as the primary complain after cardinal symptoms are controlled by DBS. Intervention: Implantable spinal cord stimulation. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic PD
- Gait and locomotion problems as the main complain/symptom
- PD patients with or without DBS
- Hoehn and Yahr scale equal or more than 2.0
Key exclusion criteria (4 listed)
- Dementia
- Hoehn and Yahr scale more than 4
- Less than 5 years of Parkinson's disease symptoms
- General contraindications of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable spinal cord stimulationAlso: Implantable SCS electrode and IPG (Medtronic)Implantation of SCS electrode and pulse generator | Procedure or surgery | DBS Parkinson's disease patients |
| Implantable spinal cord stimulationAlso: Implantable SCS electrode and IPG (Medtronic)Implantation of SCS electrode and pulse generator | Procedure or surgery | Parkinson's disease patients |
Primary outcome
Changes in locomotion capacity
Time frame: 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
3 secondary outcomes
Changes in freezing of Gait
Time frame: 6 months
Changes in quality of life
Time frame: 6 months
Motor changes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Background: PubMed 21039949Fuentes 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.
- Background: PubMed 19299613Fuentes 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.
- Results publication: PubMed 22850494Agari 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.
- Results publication: PubMed 21865071Fenelon 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.
- Results publication: PubMed 23453160Hassan 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.
- Results publication: PubMed 23227965Landi 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.
- Results publication: PubMed 20404313Thevathasan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erich T Fonoff, MD/PhD/Prof principal investigator
University of São Paulo, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable spinal cord stimulation in people with Parkinson's Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erich T Fonoff, MD/PhD/Prof (5511983268848/551126616402, fonoffet@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in locomotion capacity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02388204, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.