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ParkinsonPhase 1/2SpinalParkNCT02539784

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

A Phase 1/2 study testing Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System in people with Parkinson, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 45 to 69 years
Conditions the study is for
Parkinson
What is being tested?
Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteFrance
Study dates
Jun 2015to Jan 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Claire Thiriez, MD contact

(0)1 49 81 53 04 ext. +33

claire.thiriez@hmn.aphp.fr

Stéphane Palfi, MD, PHD contact

(0)1 49 81 39 04 ext. +33

stephane.palfi@hmn.aphp.fr

France1 site, 1 recruiting

  • Henri Mondor Hospital

    Créteil, 94010

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Parkinson
Being tested
Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System
Keywords
stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Boston Scientific Device

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

Study groups in NCT02539784
Study groupRoleWhat they receive
Spinal Cord StimulationExperimentalNot described
Receives: Device: Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of severe adverse events and adverse events reported

    Measured: at week 30

Secondary outcomes (11)

  1. Tolerance and global statement

    Clinical assessment

    Measured: After surgery (DO), at week 4, 8, 13, 18 and 30

  2. Difference of UPDRS-III scores with and without stimulation in ON or OFF medication state

    Measured: At W4, W9, W14,W30

  3. Difference of UPDRS-III scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state

    Measured: At W4, W8, W9, W13, W14,W18

  4. Difference of global UPDRS between screening and others visits, in OFF and ON medication state

    Measured: At W-4, W8, W13, W18,W30

  5. Difference of Walking Time Measurement scores with and without stimulation in ON or OFF medication state

    Measured: At W4, W9, W14,W30

  6. Difference of Walking Time Measurement scores without stimulation and after 4 weeks of continuous stimulation in ON or OFF medication state

    Measured: At W4, W8, W9, W13, W14,W18

  7. Pain assessment using visual pain scale and Saint Antoine Pain Questionnaire

    Measured: After 4, 9, 13 and 30 weeks after surgery

  8. Paresthesia assessment using visual pain scale and Saint Antoine Pain Questionnaire

    Measured: After 4, 9, 13 and 30 weeks after surgery

  9. Clinical abnormalities demonstrated during a comprehensive sensitive examination

    Measured: At W4, W8, W13, W18, W30

  10. Differences of MDRS, LARS, MADRS, PDQ-39 scores between screening and the end of the study

    Measured: At W-4 and W30

  11. Change of daily L-Dopa equivalent dose

    Measured: At W4, W8, W13, W18, W30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJan 2017 (estimated)
  4. Study completionJan 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539784
Sponsor's protocol ID
P121205
Acronym
SpinalPark
Status last verified
Jul 2016
First submitted
27 Jul 2015
Last updated
2 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Kit for Spinal Cord Stimulator System " SCS Systems " : PRECISION® System in people with Parkinson, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Claire Thiriez, MD ((0)1 49 81 53 04 ext. +33, claire.thiriez@hmn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of severe adverse events and adverse events reported (time frame: at week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2016.

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