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Thoracic Spinal Cord Stimulation as a Symptomatic Treatment for Advanced Parkinson's Disease (SpinalPark)

Primary Purpose

Parkinson

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson focused on measuring stimulation

Eligibility Criteria

45 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient from 45 to 69 years old
  • Affiliated to the French social health care system
  • Menopausal or under contraception for women
  • Parkinson's disease according to UK PDSBB's criteria with diagnosis for ≥ 5 years
  • OFF UPDRS-III ≥ 25
  • Acute dopa-response ≥ 50% for UPDRS-III in an L-Dopa challenge
  • Fluctuations with periods off ≥ 25% of the time of awakening or dyskinesia ≥ 25%
  • 3≤ Hoehn & Yahr ≤ 4
  • No change in anti-parkinsonian drugs in the last month
  • Informed consent signed for the study

Exclusion Criteria:

  • Patients major protected
  • Pregnancy
  • Deep brain stimulation or other neurosurgical treatment
  • MDRS Score < 130 or depression scale MADRS ≥ 20
  • Respiratory insufficiency (surgery belly decubitus)
  • Abnormalities on brain MRI which evoke a secondary parkinsonian syndrome
  • Spinal cord's injury on MRI or posterior cordonal's pathology on sensitive evoked potential
  • Neuropathy on EMG
  • Prior spinal surgery and spinal pathology at the dorsal level
  • Patients having already been included in therapeutic studies
  • Patient with a cardiac pacemaker, a defibrillator or any other implanted active pacemaker
  • Patient requiring diathermy process
  • Patient having a pathology requiring an MRI follow-up care

Sites / Locations

  • Henri Mondor HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord Stimulation

Arm Description

Outcomes

Primary Outcome Measures

Number of severe adverse events and adverse events reported

Secondary Outcome Measures

Tolerance and global statement
Clinical assessment
Difference of UPDRS-III scores with and without stimulation in ON or OFF medication state
Difference of UPDRS-III scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state
Difference of global UPDRS between screening and others visits, in OFF and ON medication state
Difference of Walking Time Measurement scores with and without stimulation in ON or OFF medication state
Difference of Walking Time Measurement scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state
Pain assessment using visual pain scale and Saint Antoine Pain Questionnaire
Paresthesia assessment using visual pain scale and Saint Antoine Pain Questionnaire
Clinical abnormalities demonstrated during a comprehensive sensitive examination
Differences of MDRS, LARS, MADRS, PDQ-39 scores between screening and the end of the study
Change of daily L-Dopa equivalent dose

Full Information

First Posted
July 27, 2015
Last Updated
July 31, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02539784
Brief Title
Thoracic Spinal Cord Stimulation as a Symptomatic Treatment for Advanced Parkinson's Disease
Acronym
SpinalPark
Official Title
Thoracic Spinal Cord Stimulation as a Symptomatic Treatment for Advanced Parkinson's Disease: A Phase I Safety and Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Following the so call "honey moon" period, motor symptoms of Parkinson's Disease (PD) become difficult to control with dopaminergic treatments alone. Deep brain stimulation (DBS) of the subthalamic nucleus and internal globus pallidus helps to treat fluctuating parkinsonian patients restoring a decent quality of life. However, DBS need a long, complex and invasive surgery to succeed. Thus, there is a critical need to develop alternative treatments, more accessible and less invasive. Thoracic posterior spinal cord stimulation has been used for decades to treat chronic neuropathic pains. Safety and efficacy have already been demonstrated in neuropathic pain. Experimentally, SCS has also demonstrated to improve locomotor activity in two different rodents' models of parkinson's disease. The purpose of this study is to determine whether thoracic SCS is safe and could induce a benefit motor parkinsonian symptoms without any impact on cognitive function and axial disability.
Detailed Description
The present pilot study will enroll 6 patients suffering from advanced Parkinson Disease (PD). Investigator will assess the safety, tolerance and efficacy of Spinal Cord Stimulation (SCS) with frequencies of 50, 100 and 130 Hz in a shuffle randomized for each patient. Briefly, each frequency will be evaluated immediately after and 4 weeks following SCS initiation with UPDRS-III, pain scales, and Hauser's diary. The best frequency for each patient will be then selected and maintained activated for 12 additional weeks. At the end of these 12 weeks, new assessment including UPDRS, visual pain scale, "SAINT-ANTOINE" Pain Questionary, PDQ-39 (quality of life), daily L-dopa equivalent dose, MDRS (cognitive status), LARS (apathy status) and MADRS (depression status) will be compared to the inclusion data of each patient. Primary endpoints include the safety of thoracic SCS by collected the number of adverse event and the efficacy by measuring the UPDRS-III OFF med/ON stim at 30 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson
Keywords
stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System
Other Intervention Name(s)
Boston Scientific Device
Intervention Description
3 frequencies of SCS are tested for each patient : 50, 100 and 130 Hz
Primary Outcome Measure Information:
Title
Number of severe adverse events and adverse events reported
Time Frame
at week 30
Secondary Outcome Measure Information:
Title
Tolerance and global statement
Description
Clinical assessment
Time Frame
After surgery (DO), at week 4, 8, 13, 18 and 30
Title
Difference of UPDRS-III scores with and without stimulation in ON or OFF medication state
Time Frame
At W4, W9, W14,W30
Title
Difference of UPDRS-III scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state
Time Frame
At W4, W8, W9, W13, W14,W18
Title
Difference of global UPDRS between screening and others visits, in OFF and ON medication state
Time Frame
At W-4, W8, W13, W18,W30
Title
Difference of Walking Time Measurement scores with and without stimulation in ON or OFF medication state
Time Frame
At W4, W9, W14,W30
Title
Difference of Walking Time Measurement scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state
Time Frame
At W4, W8, W9, W13, W14,W18
Title
Pain assessment using visual pain scale and Saint Antoine Pain Questionnaire
Time Frame
After 4, 9, 13 and 30 weeks after surgery
Title
Paresthesia assessment using visual pain scale and Saint Antoine Pain Questionnaire
Time Frame
After 4, 9, 13 and 30 weeks after surgery
Title
Clinical abnormalities demonstrated during a comprehensive sensitive examination
Time Frame
At W4, W8, W13, W18, W30
Title
Differences of MDRS, LARS, MADRS, PDQ-39 scores between screening and the end of the study
Time Frame
At W-4 and W30
Title
Change of daily L-Dopa equivalent dose
Time Frame
At W4, W8, W13, W18, W30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient from 45 to 69 years old Affiliated to the French social health care system Menopausal or under contraception for women Parkinson's disease according to UK PDSBB's criteria with diagnosis for ≥ 5 years OFF UPDRS-III ≥ 25 Acute dopa-response ≥ 50% for UPDRS-III in an L-Dopa challenge Fluctuations with periods off ≥ 25% of the time of awakening or dyskinesia ≥ 25% 3≤ Hoehn & Yahr ≤ 4 No change in anti-parkinsonian drugs in the last month Informed consent signed for the study Exclusion Criteria: Patients major protected Pregnancy Deep brain stimulation or other neurosurgical treatment MDRS Score < 130 or depression scale MADRS ≥ 20 Respiratory insufficiency (surgery belly decubitus) Abnormalities on brain MRI which evoke a secondary parkinsonian syndrome Spinal cord's injury on MRI or posterior cordonal's pathology on sensitive evoked potential Neuropathy on EMG Prior spinal surgery and spinal pathology at the dorsal level Patients having already been included in therapeutic studies Patient with a cardiac pacemaker, a defibrillator or any other implanted active pacemaker Patient requiring diathermy process Patient having a pathology requiring an MRI follow-up care
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Thiriez, MD
Phone
(0)1 49 81 53 04
Ext
+33
Email
claire.thiriez@hmn.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Palfi, MD, PHD
Phone
(0)1 49 81 39 04
Ext
+33
Email
stephane.palfi@hmn.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Thiriez, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Thoracic Spinal Cord Stimulation as a Symptomatic Treatment for Advanced Parkinson's Disease

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