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

Thoracic Spinal Cord Stimulation as a Symptomatic Treatment for Advanced Parkinson's Disease: A Phase I Safety and Efficacy Study

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson
• Intervention / Treatment: Device: Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Claire Thiriez, MD; Phone Number: +33 (0)1 49 81 53 04; Email: claire.thiriez@hmn.aphp.fr
• Study Contact Backup: Name: Stéphane Palfi, MD, PHD; Phone Number: +33 (0)1 49 81 39 04; Email: stephane.palfi@hmn.aphp.fr

Study Locations

• France
  • Creteil, France, 94010
    • Recruiting
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Cord Stimulation	Device: Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System; 3 frequencies of SCS are tested for each patient : 50, 100 and 130 Hz; Other Names: Boston Scientific Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of severe adverse events and adverse events reported	at week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance and global statement	Clinical assessment	After surgery (DO), at week 4, 8, 13, 18 and 30
Difference of UPDRS-III scores with and without stimulation in ON or OFF medication state		At W4, W9, W14,W30
Difference of UPDRS-III scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state		At W4, W8, W9, W13, W14,W18
Difference of global UPDRS between screening and others visits, in OFF and ON medication state		At W-4, W8, W13, W18,W30
Difference of Walking Time Measurement scores with and without stimulation in ON or OFF medication state		At W4, W9, W14,W30
Difference of Walking Time Measurement scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state		At W4, W8, W9, W13, W14,W18
Pain assessment using visual pain scale and Saint Antoine Pain Questionnaire		After 4, 9, 13 and 30 weeks after surgery
Paresthesia assessment using visual pain scale and Saint Antoine Pain Questionnaire		After 4, 9, 13 and 30 weeks after surgery
Clinical abnormalities demonstrated during a comprehensive sensitive examination		At W4, W8, W13, W18, W30
Differences of MDRS, LARS, MADRS, PDQ-39 scores between screening and the end of the study		At W-4 and W30
Change of daily L-Dopa equivalent dose		At W4, W8, W13, W18, W30

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Claire THIRIEZ, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: July 31, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: stimulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P121205