NCT02388204

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2015

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

March 8, 2015

Last Update Submit

March 12, 2015

Conditions

Parkinson's Disease

Keywords

GaitLocomotionFreezing

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (3)

  • Changes in freezing of Gait

    6 months

  • Changes in quality of life

    6 months

  • Motor changes

    6 months

Study Arms (2)

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.

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.

Procedure: Implantable spinal cord stimulation

Interventions

Implantable spinal cord stimulationPROCEDURE

Implantation of SCS electrode and pulse generator

Also known as: Implantable SCS electrode and IPG (Medtronic)
DBS Parkinson's disease patients

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Functional Neurosurgery

São Paulo, São Paulo, 01060-970, Brazil

RECRUITING

Related Publications (7)

  • 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.

    PMID: 21039949BACKGROUND

  • 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.

    PMID: 19299613BACKGROUND

  • 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.

    PMID: 22850494RESULT

  • 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.

    PMID: 21865071RESULT

  • 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.

    PMID: 23453160RESULT

  • 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.

    PMID: 23227965RESULT

  • 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.

    PMID: 20404313RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Erich T Fonoff, MD/PhD/Prof

    University of São Paulo, Department of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erich T Fonoff, MD/PhD/Prof

CONTACT

5511983268848/551126616402fonoffet@usp.br

Carolina P de Souza, MD

CONTACT

5516 33297315/551633297317carolinasouza@usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosurgery

Study Record Dates

First Submitted

March 8, 2015

First Posted

March 13, 2015

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

December 1, 2017

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

BR(1)