MedPath

Stimulation in patients with Parkinson's disease

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath