Status:
COMPLETED
Motor Cortex Stimulation for Parkinson's Disease
Lead Sponsor:
Catholic University, Italy
Collaborating Sponsors:
Medtronic
Conditions:
Parkinson's Disease
Eligibility:
All Genders
Phase:
NA
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...
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 impla...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00637260
Start Date
December 1 2007
End Date
June 1 2013
Last Update
September 2 2015
Active Locations (1)
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1
Università Cattolica - Policlinico Gemelli - Neurochirurgia Funzionale
Roma, Italy, 00168