Motor Cortex Stimulation for Parkinson's Disease

September 1, 2015 updated by: bEATRICE CIONI, Catholic University, Italy

Motor Cortex Stimulation for Parkinson's Disease. A Prospective Double Blind Randomized Study With Cross-over

Deep Brain Stimulation represents the golden standard for surgical treatment of Parkinson disease (PD), but it is not optimally effective for controlling every motor sign and adverse events are not so infrequent Therefore, other approaches should be considered.We identified the motor cortex as a possible candidate and therefore we propose a double-blind randomized prospective study in 20 Parkinson patients in order:

  • to test the efficacy of epidural motor cortex stimulation in Parkinson disease (primary endpoint: UPDRS III at 12 months at the end of the cross-over)
  • to find out optimal electrode position and optimal stimulation parameters

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

20 Parkinsonian patients will be enrolled. After implantation of a bilateral strip electrode (Resume, Medtronic) over the motor cortex, after setting of optimal stimulation parameters, and after implantation of a neurostimulator, Medtronic, the patient will be randomly assigned to group A (Motor cortex stimulation on) or to group B ( sham stimulation) for 6 months. Randomization will be based on the output of a program based on a random number generation function that will output a 0 or 1 with a 50% chance of having a 1.

At the 6 months visit, a cross-over is scheduled: group A will receive sham stimulation and group B will receive stimulation of the motor cortex for the next 6 months. In group A, the stimulation of the motor cortex will be resumed before the end of the 6 month sham stimulation, when the clinical status of the patient will come back to the status quo ante (UPDRS score equal to baseline pre-implant score).

Both the patients and the evaluating neurologists and neuropsychologists will be blind; only the neurosurgeon will know the state of the stimulator (on or off) and the position and parameters of MCS.

At 12 months, all the patients will be programmed as stimulation on and followed up for further 18 months. At 30 months visit, the clinical evaluation will be performed in on stim-on med, on stim-off med conditions; then the stimulator will be switched off for 1 month and the clinical evaluation will be repeated in off stim-off med and off stim-on med conditions.

The primary endpoint will be the UPDRS III at 12 months (end of the cross over), and subsequently at 18 and 30 months. We will compare the clinical results with the precise site of the stimulating electrodes and we will try to correlate the clinical results with the amount of inhibition induced by motor cortex stimulation.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Idiopathic PD as diagnosed by a neurologist - a movement disorders specialist, according to the Parkinson Disease Brain Bank criteria, with asymmetrical bradykinesia, rigidity, tremor and postural instability (at least 3 from the above)
  2. Significant clinical response to Levodopa (improvement of UPDRS motor score > 20%).
  3. Disease duration > 5 years
  4. Advanced stage of disease:
  5. UPDRS motor score in off condition >/= 40/108
  6. Hoehn & Yahr stage >/= 3
  7. DBS surgery not indicated or expressly refused by the patient
  8. Antiparkinsonian therapy stable for at least one month prior to implant
  9. Capability to give informed consent to surgery and to the study.

Exclusion Criteria:

  1. Severe cognitive impairment or dementia
  2. Psychiatric disturbances with the exception of mild anxiety or depression and drug-induced psychiatric symptoms (i.e. benign hallucinations)
  3. History of epilepsy or documented electroencephalographic abnormalities suggesting epilepsy
  4. Previous neurosurgery of the brain (DBS or lesioning of the basal ganglia, fetal tissue transplantation )
  5. Lack of informed consent
  6. History of drug or alcohol abuse
  7. Poor general conditions increasing surgical risk or severe illness with poor prognosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Device: Motor cortex stimulation on.
The parameters of stimulation will be: contact 0 cathode, contact 3anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5Volts. The stimulator will be switched on, continuously.
Other Names:
  • Motor cortex stimulation on
Sham Comparator: B
Device: motor cortex stimulation off
The parameters of stimulation will be: contact 0 cathode, contact 3 anode, 120microsec, 80 Hz, subthreshold for any movement or sensation, usually 3-5 volts. The stimulator will be switched off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
UPDRS III
Time Frame: 12 months - end of crossover
12 months - end of crossover

Secondary Outcome Measures

Outcome Measure
Time Frame
UPDRS III
Time Frame: 18, 30 and 31 months
18, 30 and 31 months
UPDRS
Time Frame: 6,12, 18, 30, 31 months
6,12, 18, 30, 31 months
Parkinson's disease quality of life scale(PDQL)
Time Frame: 6, 12, 18, 30, 31 months
6, 12, 18, 30, 31 months
Neuropsychological and mood evaluation
Time Frame: 6, 12, 18, 30 months
6, 12, 18, 30 months
Drug therapy
Time Frame: 6, 12, 18, 30, 31 months
6, 12, 18, 30, 31 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University, Italy

Collaborators

Medtronic

Investigators

  • Principal Investigator: Beatrice Cioni, MD, Università Cattolica Roma, Italy
  • Study Chair: Mario Meglio, Prof, MD, Università Cattolica Roma, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 820117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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