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Impacts of neurosurgery on non-motor symptoms in Parkinson's Disease patients.

Impacts of staged bilateral pallidotomy or campotomy on non-motor symptoms in Parkinson's disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-9rh8vr
Enrollment
Unknown
Registered
2018-04-18
Start date
2011-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Forty patients with Parkinson's Disease diagnosis will be evaluated in a regular follow-up at the movement disorders outclinic (Medical Specialties ambulatory) regarding surgical indication for pallid
Procedure/surgery
Other
G25.8

Sponsors

Hospital Santa Marcelina
Lead Sponsor
Hospital Santa Marcelina
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with Idiopathic Parkinson's Disease; clinical Indication for neurosurgical treatment for Parkinson's disease; Age greater than 18 Years; Stage two or greater on Hoehn and Yahr Scale in the absence of medication. Presence of significant motor dysfunction during three or more hours per day despite receiving adequate drug treatment; Persistence of motor dysfunction under revised and adequated medication regimen for at least 1 month; Consent to participate in the defined evaluations; Consent to perform surgical procedure with the purpose of treating Parkinson's symptoms; Patients who sign the Informed Consent Form according to the Norms of the Research Ethics Committee of Santa Marcelina Hospital.

Exclusion criteria

Exclusion criteria: Patients with parkinsonism associated with another degenerative disease such as Multi-systemic Atrophy; Dementia by Lewy Bodies; Alzheimer's disease; Cortico-Basal degeneration; Fronto-temporal dementia; cerebellar ataxia. Patients with suspected secondary parkinsonism such as cerebral vascular disease; Use of medications; Normal pressure hydrocephalus; Traumatic brain injury. Patients with previous surgical treatment for Parkinson's Disease as pallidotomy; talamotomy or electrode Implant for deep brain stimulation. Patients with clinical or cardiologic contraindications to perform the surgical procedure. Current use of neuroleptic drugs for the treatment of behavior disorders or hallucinations associated with the use of dopaminergic drugs. Patients with schooling Level very Low (below 2 Years) or with auditory or visual deficiency, in such a way as to Inviabilize neuropsychological evaluation. Personal history of alcohol abuse. Diagnosis of current severe depression, according to DSM-IV criteria - American Psychiatric Association 2000. Patients with dementia diagnosis associated with Parkinson's disease according to the criteria stablished by the movement disorders society.

Design outcomes

Primary

MeasureTime frame
Reduction in the severity and frequency of non-motor symptoms after 6 months and one year of the neurosurgical procedure, verified by applying the scale of non-motor symptoms for Parkinson's Disease, based on a reduction of at least 20% in severity and 5% on the frequency of the symptom.;Reduction 44.1% in mood scores and cognitive disorders of the unified scale of Parkinson's Disease. Reduction of 31% in pain scores on the visual pain scale. No significant differences were observed in the frequency and severity of the other non-motor symptoms evaluated by the non-motor symptoms scale.

Secondary

MeasureTime frame
Spectral analysis of the activity of neuronal units located in the Subthalamic Nucleus and the Inner Pale Globe to the specific nociceptive stimulation, by comparing intraoperative unit action potentials, evoked to laser stimulation, among Parkinsonian patients with or without central pain.;Due to technical issues, it was not possible to proceed with laser stimulations in the surgical center setting. Therefore we have no observed outcome to this point.

Countries

Brazil

Contacts

Public ContactMaria Sheila Rocha

Hospital Santa Marcelina

msrocha@uol.com.br+55-11-981384300

Outcome results

None listed

Source: REBEC (via WHO ICTRP)