Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00637260
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00637260
Study Brief:
Protocol Section:
NCT00637260