Analysis of Cortical Biomarkers for PD

NCT03645538 | Unknown

• 1 other identifier: Cortical_Biomarkers_EEG_ PD
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Previous studies revealed changes in the pattern of cortical electrical activity of patients with Parkinson's disease (PD) and suggested that these changes may be dependent on the phenotypes of the disease and other related factors. A greater understanding of cortical electrical activity in PD patients may be relevant to guide professionals about the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). The present study aims to evaluate the pattern of brain activity of PD patients and to correlate the findings with the disease phenotypes and with other clinical characteristics. For this, volunteers with PD and healthy will participate in a single experimental session in which behavioral and electrophysiological assessments will be performed.

Conditions

Parkinson Disease; Healthy

Keywords

Parkinson's disease; Healthy subjects

Outcome Measures

Primary Outcomes (1)

• Change in cortical activity

  For EEG assessment, the electrodes will be positioned on the scalp of the individual, according to the international 10-20 marking system, maintained with the maximum impedance of 10kΩ. During the acquisition of the electroencephalographic signal, a motor imagery and execution protocol will be performed, in both upper limbs. The collected data will be further processed and analyzed by MATLAB® software for Windows.

  before and 1 hour after the medication ingestion.

Secondary Outcomes (2)

• Change in motor threshold

  before and 1 hour after the medication ingestion.

• Change in motor evoked potentials

  before and 1 hour after the medication ingestion.

Other Outcomes (7)

• Change in functional mobility

  before and 1 hour after the medication ingestion.

• Change in balance

  before and 1 hour after the medication ingestion.

• Change in motor impairment

  before and 1 hour after the medication ingestion.

Study Arms (2)

Parkinson's disease patients

PD patients, after reading and signing the free and informed consent will be submitted to a single session to obtain the normal neurophysiological and behavioral endpoints and thus compare with those obtained in healthy individuals. All volunteers (healthy and patients) will be submitted to a behavioral and neurophysiological evaluation through transcranial magnetic stimulation (TMS) and electroencephalography (EEG). The neurophysiological evaluation will be conducted during "ON" (with medication) and "OFF" (without medication) period, by transcranial magnetic stimulation by single pulse (EMT-p) and by EEG.

Other: Parkinson's disease patients

No drug - Control group

PD patients, after reading and signing the free and informed consent will be submitted to a single session to obtain the normal neurophysiological and behavioral endpoints and thus compare with those obtained in healthy individuals. All volunteers (healthy and patients) will be submitted to a behavioral and neurophysiological evaluation through transcranial magnetic stimulation (TMS) and electroencephalography (EEG).

Other: No drug

Interventions

Parkinson's disease patients OTHER

The neurophysiological evaluation will be conducted during "ON" (with medication) and "OFF" (without medication) period, by transcranial magnetic stimulation by single pulse (EMT-p) and by EEG.

Parkinson's disease patients

No drug OTHER

The neurophysiological evaluation in healthy subjects will be conducted by transcranial magnetic stimulation by single pulse (EMT-p) and by EEG.

No drug - Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be invited to participate in the study from broad divulgation of research through print and digital media. Volunteers with PD and healthy who meet the inclusion and exclusion criteria of the study will be selected by means of non-probabilistic sampling.

You may qualify if:

• · Ages: 40 years or greater
• Gender: Both
• Minimum score of the Montreal Cognitive Assessment (MoCA) (27 points);
• Regular antiparkinsonian pharmacological treatment;
• Staged from I to IV on the modified Hoehn \& Yahr scale.
• Ages: 40 years or greater
• Gender: Both
• Subjects who do not have self-report of neurological or articular disorder

You may not qualify if:

• · Pregnant women;
• Pacemaker;
• History of seizures;
• Metallic implants in the head;
• Patients with clinical evidence of brain injuries;
• Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
• Other diseases in lower limbs that interfere with performance and locomotion;
• Submitted to previous surgical intervention for PD.
• Pregnant women;
• Pacemaker;
• History of seizures;
• Metallic implants in the head;
• Patients with clinical evidence of brain injuries;
• Chronic pain associated to other diseases;
• Use of neuroleptic medications

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (2)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50670-900, Brazil

RECRUITING

Applied Neuroscience Laboratory

Recife, Pernambuco, 50740-560, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Lívia Shirahige, MsC

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

• Adriana Maciel, MsC

  Universidade Federal de Pernambuco

  STUDY CHAIR

• Déborah Oliveira, MsC

  Universidade Federal de Pernambuco

  STUDY CHAIR

• Fernanda Nogueira, Bachelor

  Universidade Federal de Pernambuco

  STUDY CHAIR

• Marina Berenguer, Bachelor

  Universidade Federal de Pernambuco

  STUDY CHAIR

• Brenda Valença

  Universidade Federal de Pernambuco

  STUDY CHAIR

• Rodrigo Brito, Bachelor

  Universidade Federal de Pernambuco

  STUDY CHAIR

Central Study Contacts

Kátia Monte-Silva, PhD

CONTACT

+55 81 9988631322; monte.silvakk@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 24, 2018
• Study Start: September 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2020
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)