Analysis of Cortical Biomarkers for Parkinson's Disease Patients

Analysis of Cortical Biomarkers for PD

Sponsors

Lead sponsor: Universidade Federal de Pernambuco

Source Universidade Federal de Pernambuco
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.

Detailed Description

Healthy individuals, 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 individuals with PD. 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. TMS can perform different measures for the study of cortical excitability. The analysis of the motor cortex excitability will be held by: (i) determination of motor threshold (ii) the amplitude of the motor evoked potential (MEP). Since the assessment of the cortex activity will be held by: (i) power spectrum density (PSD) of all frequencies bands.75 For evaluation with the TMS (Neurosoft - Russia) volunteers will be instructed to sit in a chair and get comfortable position. Initially single TMS stimuli will be administered over the motor cortex to determine the cortical representation area of the first dorsal interosseous muscle (FDI) - MEP region whose response occurs more intensely observed by electromyography. The electrodes with 10 mm diameter should be placed on the belly of the target muscle and the reference electrode is placed in the interphalangeal joint of the thumb. All care for the acquisition of electromyographic signal will be taken according to the criteria of Surface Electromyography for the Non-invasive Assessment of Muscles (SENIAM).

For the location of the representative FDI muscle cortical region coil with an angle of 45 degrees is positioned at a distance of 20% of Cz point (according to the international system for marking 10-20) bring into the contralateral muscle to be evaluated. For all evaluations the same coil is used, the figure-eight angled in order to avoid measurement bias. To assess cortical excitability of both hemispheres, the following measures are carried out: resting motor threshold (RMT) and motor evoked potentials (MEP).

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.

For behavioral assessment the following scales and tests will be performed during "ON" (with medication) and "OFF" (without medication) period: Parkinson's disease sleep scale; Geriatric Depression Scale; Edinburgh Handedness Inventory; International Physical Activity Questionnaire; Timed up and go test; Berg Balance Scale; Unified Parkinson's disease Rating Scale sessions II and III.

Overall Status Recruiting
Start Date September 1, 2018
Completion Date January 30, 2020
Primary Completion Date January 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Change in cortical activity before and 1 hour after the medication ingestion.
Secondary Outcome
Measure Time Frame
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.
Enrollment 20
Condition
Intervention

Intervention type: Other

Intervention name: Parkinson's disease patients

Description: 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.

Arm group label: Parkinson's disease patients

Intervention type: Other

Intervention name: No drug

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

Arm group label: No drug - Control group

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- · 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.

Healthy Subjects inclusion criteria:

- Ages: 40 years or greater

- Gender: Both

- Subjects who do not have self-report of neurological or articular disorder

Exclusion Criteria:

- · 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.

Healthy Subjects exclusion criteria:

- 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

- Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests.

Gender: All

Minimum age: 40 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last name: Kátia Monte-Silva, PhD

Phone: +55 81 9988631322

Email: [email protected]

Location
facility status contact contact_backup investigator
Applied Neuroscience Laboratory | Recife, Pernambuco, 50670-900, Brazil Recruiting Fernanda N Nogueira, PT + 55 81 99989 2636 [email protected] Lívia Shirahige, MSc Sub-Investigator
Applied Neuroscience Laboratory | Recife, Pernambuco, 50740-560, Brazil Recruiting Kátia K Monte Silva, PhD Principal Investigator
Location Countries

Brazil

Verification Date

September 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Universidade Federal de Pernambuco

Investigator full name: Kátia Monte-Silva

Investigator title: Clinical professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Parkinson's disease patients

Description: 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.

Arm group label: No drug - Control group

Description: 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).

Patient Data No
Study Design Info

Observational model: Other

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov