Parkinson's disease
Conditions
Interventions
This clinical trial will randomize 30 Parkinson's disease patients to either best medical oral treatment ((levodopa
amantadine) or bilateral deep brain stimulation on Forel's field. Best medical treatment will be sustained for six months (habitual dosages and regimes - there will no be changes in usual dosages), wh
all patients and controls will be paired to age, disease severity, disease duration and clinical subtype. Clinical and neuropsychological evaluations will be performed before surgery (within 30 days)
the definition for best stimulations parameters will be achieved by the experienced neurologist step by step (each two weeks), according to the standard stimulation algorithm. This aims to figure out
Procedure/surgery
Other
H02.403.810.425
Sponsors
Hospital Santa Marcelina
Hospital Santa Marcelina
Eligibility
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with Idiopathic Parkinson's disease according to the criteria of Queen Square Brain Bank; be over 35 years of age and less than 80 y-old; staging of Parkinson's Disease (Hoehn and Yahr scale), greater than 2 when evaluated in the absence of antiparkinsonian drugs effect; preserved clinical response to levodopa, the patient should present at least 30 percent reduction in the score of motor score the UPDRS scale; significant motor dysfunctions for 3 hours per day or more, despite the best drug treatment; persistent motor dysfunction for at least 1 month despite drug adjustment; patient's desire to receive deep brain stimulation as a therapeutic option in PD; adequate cognitive performance for the demand associated with the necessary care in the postoperative, with the DBS equipments, and in the recognition of adverse events; availability of the caregiver or family member, and of the patient himself, to come in frequent returns to ensure the best parameters of brain stimulation
Exclusion criteria
Exclusion criteria: Parkinsonism associated with other neurodegenerative diseases (multisystemic atrophy; dementia with Lewy bodies; corticobasal degeneration; frontotemporal dementia; spinocerebellar ataxia); vascular parkinsonism; parkinsonism associated with antidopaminergic drugs; normal pressure hydrocephalus; traumatic brain injury; previous surgical treatment for Parkinson's Disease (pallidotomy, thalamotomy, campotomy or deep brain stimulation); patients with uncompensated systemic pathology; Parkinson's disease associated psychosis; major depression according to DSM-IV criteria - American Psychiatric Association 2000; dementia associated with Parkinson's disease, according to the criteria of the Movement Disorders Society
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score on freezing of gait questionnaire for Parkinson's disease after six months and one year of effective brain stimulation on Forel's field.;Total score on Berg Balance scale after six months and one year of effective brain stimulation on Forel's field.;Parameters of instrumented gait analysis through Mobility Lab equipment performed before and after six months and one year of effective brain stimulation on Forel's field. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total scores in the Quality of Life Scale (PDQ39) obtained after six months and one year of effective brain stimulation on Forel's field.;Total motor score on UPDRS (Unified Parkinson's disease rating scale) after six months and one year of effective brain stimulation on Forel's field.;Verbal fluency score on phonemic and categorical verbal fluency tests after six months and one year of effective brain stimulation on Forel's field.;Score on depression scale (Beck depression inventory) after six months and one year of effective brain stimulation on Forel's field. | — |
Countries
Brazil
Contacts
Public ContactMaria Sheila Rocha
Hospital Santa Marcelina
Outcome results
None listed