Stimulation in patients with Parkinson's disease
- Conditions
- Parkinson's disease
- Registration Number
- RBR-6sc7tp
- Lead Sponsor
- Faculdade de Medicina da Univeridade de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Patients diagnosed with idiopathic PD according to Queen Square Brain Bank criteria 23.
The diagnosis will be given by a neurologist specializing in movement disorders.
Presence of moderate PD, at least 4 years from the onset of motor symptoms.
Persistent motor dysfunction for at least 1 month despite drug adjustment.
Patients with moderate to severe gait disturbances and refractory balance to drug treatment.
Thus, they should have: score 3 (moderate) or 4 (severe) in items 12 and 13 of part II of the MDS-UPDRS and score 3 (moderate) or 4 (severe) in items 9, 10, 11 and 12 of part III UPDRS being on medication (medication status ON).
Cognitive performance appropriate to preoperative care.
Understanding of the stimulation system and recognition of adverse events.
Willingness of the caregiver or family member, and the patient himself, to come in frequent returns to ensure the best brain stimulation parameters.
Age under 18 years.
Parkinsonism Associated With Other Degenerative Diseases
Secondary Parkinsonism.
Prior surgical treatment of PD symptoms.
Patients without clinical conditions for the surgical procedure due to noncompensated systemic disease.
Behavioral disorders and hallucinations associated with dopamine drug use and without drug control.
Patients with less than two years of schooling or visually impaired who cannot perform properly on neuropsychological tests.
Depression.
Dementia associated with PD
Refusal to undergo neurosurgical procedure.
Refusal to accept the informed consent form.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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