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

NCT02539784 | Unknown Phase 1

• 1 other identifier: P121205
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson

Keywords

stimulation

Outcome Measures

Primary Outcomes (1)

• Number of severe adverse events and adverse events reported

  at week 30

Secondary Outcomes (11)

• Tolerance and global statement

  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

Study Arms (1)

Spinal Cord Stimulation

EXPERIMENTAL

Device: Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System

Interventions

Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System DEVICE

3 frequencies of SCS are tested for each patient : 50, 100 and 130 Hz

Also known as: Boston Scientific Device

Spinal Cord Stimulation

Eligibility Criteria

• Age: 45 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• ≤ Hoehn \& Yahr ≤ 4
• No change in anti-parkinsonian drugs in the last month
• Informed consent signed for the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

RECRUITING

Study Officials

• Claire Thiriez, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Thiriez, MD

CONTACT

(0)1 49 81 53 04; claire.thiriez@hmn.aphp.fr

Stéphane Palfi, MD, PHD

CONTACT

(0)1 49 81 39 04; stephane.palfi@hmn.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: September 3, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 2, 2016

Record last verified: 2016-07

Locations

FR (1)