Motor Cortex Stimulation for Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Motor cortex stimulation on.
motor cortex stimulation off
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson's Disease focused on measuring motorcortex stimulation, Parkinson's disease, neuromodulation
Eligibility Criteria
Inclusion Criteria:
- 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)
- Significant clinical response to Levodopa (improvement of UPDRS motor score > 20%).
- Disease duration > 5 years
- Advanced stage of disease:
- UPDRS motor score in off condition >/= 40/108
- Hoehn & Yahr stage >/= 3
- DBS surgery not indicated or expressly refused by the patient
- Antiparkinsonian therapy stable for at least one month prior to implant
- Capability to give informed consent to surgery and to the study.
Exclusion Criteria:
- Severe cognitive impairment or dementia
- Psychiatric disturbances with the exception of mild anxiety or depression and drug-induced psychiatric symptoms (i.e. benign hallucinations)
- History of epilepsy or documented electroencephalographic abnormalities suggesting epilepsy
- Previous neurosurgery of the brain (DBS or lesioning of the basal ganglia, fetal tissue transplantation )
- Lack of informed consent
- History of drug or alcohol abuse
- Poor general conditions increasing surgical risk or severe illness with poor prognosis.
Sites / Locations
- Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
UPDRS III
Secondary Outcome Measures
UPDRS III
UPDRS
Parkinson's disease quality of life scale(PDQL)
Neuropsychological and mood evaluation
Drug therapy
Full Information
NCT ID
NCT00637260
First Posted
March 10, 2008
Last Updated
September 1, 2015
Sponsor
Catholic University, Italy
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00637260
Brief Title
Motor Cortex Stimulation for Parkinson's Disease
Official Title
Motor Cortex Stimulation for Parkinson's Disease. A Prospective Double Blind Randomized Study With Cross-over
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University, Italy
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
motorcortex stimulation, Parkinson's disease, neuromodulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Motor cortex stimulation on.
Other Intervention Name(s)
Motor cortex stimulation on
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
motor cortex stimulation off
Intervention Description
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.
Primary Outcome Measure Information:
Title
UPDRS III
Time Frame
12 months - end of crossover
Secondary Outcome Measure Information:
Title
UPDRS III
Time Frame
18, 30 and 31 months
Title
UPDRS
Time Frame
6,12, 18, 30, 31 months
Title
Parkinson's disease quality of life scale(PDQL)
Time Frame
6, 12, 18, 30, 31 months
Title
Neuropsychological and mood evaluation
Time Frame
6, 12, 18, 30 months
Title
Drug therapy
Time Frame
6, 12, 18, 30, 31 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Significant clinical response to Levodopa (improvement of UPDRS motor score > 20%).
Disease duration > 5 years
Advanced stage of disease:
UPDRS motor score in off condition >/= 40/108
Hoehn & Yahr stage >/= 3
DBS surgery not indicated or expressly refused by the patient
Antiparkinsonian therapy stable for at least one month prior to implant
Capability to give informed consent to surgery and to the study.
Exclusion Criteria:
Severe cognitive impairment or dementia
Psychiatric disturbances with the exception of mild anxiety or depression and drug-induced psychiatric symptoms (i.e. benign hallucinations)
History of epilepsy or documented electroencephalographic abnormalities suggesting epilepsy
Previous neurosurgery of the brain (DBS or lesioning of the basal ganglia, fetal tissue transplantation )
Lack of informed consent
History of drug or alcohol abuse
Poor general conditions increasing surgical risk or severe illness with poor prognosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatrice Cioni, MD
Organizational Affiliation
Università Cattolica Roma, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mario Meglio, Prof, MD
Organizational Affiliation
Università Cattolica Roma, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale
City
Roma
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17691309
Citation
Cioni B. Motor cortex stimulation for Parkinson's disease. Acta Neurochir Suppl. 2007;97(Pt 2):233-8. doi: 10.1007/978-3-211-33081-4_26.
Results Reference
background
PubMed Identifier
15986739
Citation
Pagni CA, Altibrandi MG, Bentivoglio A, Caruso G, Cioni B, Fiorella C, Insola A, Lavano A, Maina R, Mazzone P, Signorelli CD, Sturiale C, Valzania F, Zeme S, Zenga F. Extradural motor cortex stimulation (EMCS) for Parkinson's disease. History and first results by the study group of the Italian neurosurgical society. Acta Neurochir Suppl. 2005;93:113-9. doi: 10.1007/3-211-27577-0_19.
Results Reference
background
PubMed Identifier
18083500
Citation
Cioni B, Meglio M, Perotti V, De Bonis P, Montano N. Neurophysiological aspects of chronic motor cortex stimulation. Neurophysiol Clin. 2007 Dec;37(6):441-7. doi: 10.1016/j.neucli.2007.10.007. Epub 2007 Nov 1.
Results Reference
background
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Motor Cortex Stimulation for Parkinson's Disease
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