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Stimulation in patients with Parkinson's disease

Stimulation of the Pontino peduncle nucleus area in patients with Parkinson's disease evaluation of motor results focusing on gait changes falls balance and impact on quality of life - Stimulation of the nucleus area of ??the Pontino peduncle in patients with Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6sc7tp
Enrollment
Unknown
Registered
2020-08-24
Start date
2019-10-01
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

five patients with PD will undergo stereotactic implantation of electrodes guided by the technique of magnetic resonance tractography. Postoperative radiological evaluation will inform the contacts pr
(ii) flow electrode at low frequency (<70 Hz)
(iii) high frequency rostral electrode + low frequency caudal electrode
(iv) electrodes disconnected. A neurologist blind to the above conditions will perform an assessment using the following scales: (i) UPDRS
(ii) Berg
(iii) March Blocking
(iv) Epworth
(v) PDQ-39. Patients will also be evaluated in a gait laboratory, using a force platform and accelerometers. Assessments for each condition will start in the fourth week after surgery and will be spac
Procedure/surgery
E01.370.350.578.750

Sponsors

Faculdade de Medicina da Univeridade de São Paulo
Lead Sponsor
Faculdade de Medicina da Univeridade de São Paulo
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Presentation of the expected outcome: It is expected to evaluate: 1. Intensity of symptoms stiffness, tremor and bradykinesia; ;Presentation of the expected outcome: It is expected to evaluate: 2. Severity of FOG and imbalance;

Secondary

MeasureTime frame
We will study the impact on motor performance and quality of life of patients with PD presenting gait disturbance and balance refractory to drug treatment

Countries

Brazil

Contacts

Public ContactFabio;Fábio Godinho;Godinho

FMUSP;FMUSP

godinho.f1@gmail.com;godinho.f1@gmail.com3171-2717;55-11-22173766

Outcome results

None listed

Source: REBEC (via WHO ICTRP)