Parkinson DiseaseNCT03645538
Analysis of Cortical Biomarkers for PD
An observational study of Parkinson Disease and Healthy, run by Universidade Federal de Pernambuco at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Healthy
- What is being tested?
- Parkinson's disease patients and No drug
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2018to 30 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- · 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:
Show all 9Show fewer
- Ages: 40 years or greater
- Gender: Both
- Subjects who do not have self-report of neurological or articular disorder
Who cannot join
- · 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Applied Neuroscience Laboratory
Recife, Pernambuco, 50670-900
Fernanda N Nogueira, PT, + 55 81 99989 2636, fernandanrn@hotmail.com
Marina F Berenguer, PT, +55 81 99745 6028, marinaberenguer@hotmail.com
- Recruiting
Applied Neuroscience Laboratory
Recife, Pernambuco, 50740-560
Kátia K Monte Silva, PhD
About this study
Official title: Analysis of Cortical Biomarkers for Parkinson's Disease Patients
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.
Read the 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.
- Conditions
- Parkinson Disease, Healthy
- Being tested
- Parkinson's disease patients, No drug
- Keywords
- Parkinson's disease, Healthy subjects
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkinson's disease patientsOther
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.
No drugOther
The neurophysiological evaluation in healthy subjects will be conducted by transcranial magnetic stimulation by single pulse (EMT-p) and by EEG.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before and 1 hour after the medication ingestion.
Secondary outcomes (2)
Change in motor threshold
to determine the resting motor threshold (RMT), the minimum of stimulator output necessary to emit 5 pulses with amplitudes above 50 microvolts in 10 trials. The investigators will use the motor threshold assessment tool to perform RMT assessment. Motor threshold means a measure of pyramidal neurons.
Measured: before and 1 hour after the medication ingestion.
Change in motor evoked potentials
to measure the MEP, the intensity of the magnetic stimulator will be adjusted to 120% of RMT and 20 stimuli will be registered. The volunteer will be sitted, completely relaxed. The amplitude means of evoked potentials will determine the MEP.
Measured: before and 1 hour after the medication ingestion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Lívia Shirahige, MsC, Principal investigator, Universidade Federal de PernambucoAdriana Maciel, MsC, Study chair, Universidade Federal de PernambucoDéborah Oliveira, MsC, Study chair, Universidade Federal de PernambucoFernanda Nogueira, Bachelor, Study chair, Universidade Federal de PernambucoMarina Berenguer, Bachelor, Study chair, Universidade Federal de PernambucoBrenda Valença, Study chair, Universidade Federal de PernambucoRodrigo Brito, Bachelor, Study chair, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645538
- Sponsor's protocol ID
- Cortical_Biomarkers_EEG_ PD
- Status last verified
- Sep 2019
- First submitted
- 25 Jul 2018
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cortical Biomarkers for Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT03645538
- Acronym / sponsor ID
- Cortical_Biomarkers_EEG_ PD
- Conditions
- Parkinson Disease, Healthy
- Keywords
- Parkinson's disease, Healthy subjects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Other: Parkinson's disease patientsPD 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. |
| No drug - Control group | – | Other: No drugPD 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). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- · Ages: 40 years or greater
- Ages: 40 years or greater
- Gender: Both
- Subjects who do not have self-report of neurological or articular disorder
Key exclusion criteria (17 listed)
- · Pregnant women;
- Pregnant women;
- Pacemaker;
- History of seizures;
- Metallic implants in the head;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parkinson's disease patientsThe 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 drugThe neurophysiological evaluation in healthy subjects will be conducted by transcranial magnetic stimulation by single pulse (EMT-p) and by EEG. | Other | No drug - Control group |
Primary outcome
Change in cortical activity
Time frame: before and 1 hour after the medication ingestion.
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.
2 secondary outcomes
Change in motor threshold
Time frame: before and 1 hour after the medication ingestion.
Change in motor evoked potentials
Time frame: before and 1 hour after the medication ingestion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lívia Shirahige, MsC principal investigator
Universidade Federal de Pernambuco
Adriana Maciel, MsC study chair
Universidade Federal de Pernambuco
Déborah Oliveira, MsC study chair
Universidade Federal de Pernambuco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Healthy, run by Universidade Federal de Pernambuco at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kátia Monte-Silva, PhD (+55 81 9988631322, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cortical activity (time frame: before and 1 hour after the medication ingestion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.