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

Parkinson Clinical Trial

— SpinalPark  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02539784
• Other study ID #: P121205
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 27, 2015
• Last updated: July 31, 2016
• Start date: June 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Claire Thiriez, MD
• Phone: (0)1 49 81 53 04
• Email: claire.thiriez[@]hmn.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 69 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of severe adverse events and adverse events reported		at week 30	Yes
Secondary	Tolerance and global statement	Clinical assessment	After surgery (DO), at week 4, 8, 13, 18 and 30	Yes
Secondary	Difference of UPDRS-III scores with and without stimulation in ON or OFF medication state		At W4, W9, W14,W30	No
Secondary	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	No
Secondary	Difference of global UPDRS between screening and others visits, in OFF and ON medication state		At W-4, W8, W13, W18,W30	No
Secondary	Difference of Walking Time Measurement scores with and without stimulation in ON or OFF medication state		At W4, W9, W14,W30	No
Secondary	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	No
Secondary	Pain assessment using visual pain scale and Saint Antoine Pain Questionnaire		After 4, 9, 13 and 30 weeks after surgery	No
Secondary	Paresthesia assessment using visual pain scale and Saint Antoine Pain Questionnaire		After 4, 9, 13 and 30 weeks after surgery	No
Secondary	Clinical abnormalities demonstrated during a comprehensive sensitive examination		At W4, W8, W13, W18, W30	No
Secondary	Differences of MDRS, LARS, MADRS, PDQ-39 scores between screening and the end of the study		At W-4 and W30	No
Secondary	Change of daily L-Dopa equivalent dose		At W4, W8, W13, W18, W30	No