Parkinson DiseaseNCT04221659
Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients
A study testing Transcranial Direct Current Stimulation in people with Parkinson Disease, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
Parkinson's disease (PD) is a neurodegenerative and progressive movement disorder, whose population incidence is increasing. It is characterized by motor symptoms such as tremor, stiffness and bradykinesia, and non-motor symptoms, highlighting the executive dysfunction that can be present from the early stages of the… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2019to Jan 2021
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD, issued by a neurologist specializing in movement disorders;
- Disease staging between I and III, according to the modified Hoehn and Yahr scale;
- Regular antiparkinsonian pharmacological treatment;
- Score higher than 24 or 18 (for participants with low education) in the Mini -Mental State Examination
- Healthy Subjects inclusion criteria:
- Ages: 40 - 75 years
- Sex: All
- Subjects who do not have self-report of neurodegenerative disorders
Who cannot join
- Diagnosis of atypical parkinsonism;
- Neurological comorbidities;
- History of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation;
- DBS implantation - deep brain stimulation;
- Patients missing two consecutive protocol sessions.
- Healthy Subjects exclusion criteria:
Show all 9Show fewer
- History of epilepsy;
- Metallic implants in the head;
- Clinical evidence of brain injury.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Suellen Marinho Andrade
João Pessoa, Paraíba
Suellen Andrade, suellenandrade@gmail.com
About this study
Official title: Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients: Randomized Controlled Trial
Parkinson's disease (PD) is a neurodegenerative and progressive movement disorder, whose population incidence is increasing. It is characterized by motor symptoms such as tremor, stiffness and bradykinesia, and non-motor symptoms, highlighting the executive dysfunction that can be present from the early stages of the disease. These deficits increase the risk of falls and reduce functional independence. Transcranial Direct Current Stimulation (ETCC) can be an attractive rehabilitation option in PD because it is a non-invasive and safe method that can modulate cortical excitability and improve motor and non-motor symptoms. One of the techniques to detect neurophysiological biomarkers associated with changes in the functional health of the brain and the effectiveness of this type of treatment is the analysis of microstates from the electroencephalogram (EEG). So, the objective of the present study is to investigate the effects of different assemblies of multifocal ETCC on the electrical brain activity represented by the EEG microstates and clinical characteristics in patients with PD.
Read the detailed description
For this, a randomized, triple-blind clinical trial will be conducted with 60 people with PD, between 40 and 75 years old, regardless of sex, recruited from the reference centers in neurology and physiotherapy in João Pessoa-PB. Participants will be randomized into three groups: Group 1 - ETCC over M1 + CPFDL; Group 2 - ETCC on M1 + APF; Group 3 - ETCC on M1. In each condition an initial baseline assessment (T0) will be performed after 16 treatment sessions (T1) and 30 days after the end of the protocol (Follow-up Assessment - T2). The evaluated outcomes will be: analysis of microstates and spectral analysis of frequencies by EEG; dual task capability with Timed Up and Go (TUG); executive function (Stroop test and verbal fluency test); motor aspects of daily life (MDS UPDRS II). For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, Version 20.0, will be used and statistical significance considered at 5% (p ≤ 0.05).
- Conditions
- Parkinson Disease
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Participants will receive 16 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, on alternate days (3 times a week). The current will be delivered via saline-embedded sponge surface electrodes using a battery-powered neurostimulator (TCT-Research, Trans Cranial Technologies, Hong Kong). A small active specific electrode (5x5 cm) will be used to prevent coverage of adjacent areas, resulting in a current density of 0.08 mA / cm². The cathode, reference electrode (5x7cm), will be positioned in the occipital region. These parameters are within the safe limits established in previous human studies.
| Study group | Role | What they receive |
|---|---|---|
| tDCS over M1 and DLPFC | Experimental | Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC). Duration: 20 minutes; Intensity: 2mA. Receives: Device: Transcranial Direct Current Stimulation |
| tDCS over M1 and FPA | Experimental | Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and left frontal polar area (FPA). Duration: 20 minutes; Intensity: 2mA. Receives: Device: Transcranial Direct Current Stimulation |
| tDCS over M1 | Active comparator | Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG microstates
For the analysis of the EEG microstates the following temporal parameters will be considered: the average duration of each microstate; its frequency of occurrence; the fraction of the total recording time covered by each; the overall variation explained by each microstate and the probabilities of transition from one microstate to another.
The brain electrical activity will be acquired through the BrainVision actiCHamp equipment using 32 Ag / AgCl electrodes that will be fixed according to the International 10-20 System, keeping the impedance below 10kΩ in silent condition and in eyes open states. and eyes closed. The output of the amplifier data will be directed to a computer with BrainVision Pycoder software to record the obtained records and the data will be processed using the BrainVision Analyzer.
Measured: Baseline, after 6 weeks, and after 10 weeks
Secondary outcomes (5)
Spectral analysis of EEG frequencies
Analyze the average of the spectra in the different frequency bands and identify their predominant cortical regions.
The brain electrical activity will be acquired through the BrainVision actiCHamp equipment using 32 Ag / AgCl electrodes that will be fixed according to the International 10-20 System, keeping the impedance below 10kΩ in silent condition and in eyes open states. and eyes closed. The output of the amplifier data will be directed to a computer with BrainVision Pycoder software to record the obtained records and the data will be processed using the BrainVision Analyzer.
Measured: Baseline, after 6 weeks, and after 10 weeks
Motor aspects of daily life
The Unified Parkinson's Disease Assessment Scale - Part II (MDS-UPDRS) will be used to assess the motor experiences of daily life.
Measured: Baseline, after 6 weeks, and after 10 weeks
Stroop test
A modified version of the Stroop Test will be used, the Victoria Stroop Test (VST), which uses three conditions: name the color 24 points, 24 neutral words and 24 colorful words printed in incongruous colors.
Measured: Baseline, after 6 weeks, and after 10 weeks
Dual Task
Participants will perform single and double task conditions with Timed Up and Go (TUG). First, only TUG (TUGS) is performed, a single attention task in which the participant will be instructed to get up from a chair, walk at a normal and safe pace for three meters, rotate 180 degrees, come back and sit down. Then the TUG will be performed simultaneously performing the cognitive task of generating a word list starting with a specific letter, speaking out loud (TUGC), and performing the TUG with the motor task of carrying a glass of water ( TUGM).
Measured: Baseline, after 6 weeks, and after 10 weeks
Verbal Fluency Test
The FAS is a verbal fluency test, in which participants must name as many unique words as possible starting with the letters F, A and S in separate tests, and each condition has a time limit of 60 seconds.
Measured: Baseline, after 6 weeks, and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Dec 2019
- Primary completionNov 2020 (estimated)
- Study completionJan 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221659
- Sponsor's protocol ID
- EEGPark
- Status last verified
- Apr 2020
- First submitted
- 6 Jan 2020
- Last updated
- 4 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04221659
- Acronym / sponsor ID
- EEGPark
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 9 Jan 2020 (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.
Parkinson's disease (PD) is a neurodegenerative and progressive movement disorder, whose population incidence is increasing. It is characterized by motor symptoms such as tremor, stiffness and bradykinesia, and non-motor symptoms, highlighting the executive dysfunction that can be present from the early stages of the disease. These deficits increase the risk of falls and reduce functional independence. Transcranial Direct Current Stimulation (ETCC) can be an attractive rehabilitation option in PD because it is a non-invasive and safe method that can modulate cortical excitability and improve motor and non-motor symptoms. One of the techniques to detect neurophysiological biomarkers associated with changes in the functional health of the brain and the effectiveness of this type of treatment is the analysis of microstates from the electroencephalogram (EEG). So, the objective of the present study is to investigate the effects of different assemblies of multifocal ETCC on the electrical brain activity represented by the EEG microstates and clinical characteristics in patients with PD.
Detailed description
For this, a randomized, triple-blind clinical trial will be conducted with 60 people with PD, between 40 and 75 years old, regardless of sex, recruited from the reference centers in neurology and physiotherapy in João Pessoa-PB. Participants will be randomized into three groups: Group 1 - ETCC over M1 + CPFDL; Group 2 - ETCC on M1 + APF; Group 3 - ETCC on M1. In each condition an initial baseline assessment (T0) will be performed after 16 treatment sessions (T1) and 30 days after the end of the protocol (Follow-up Assessment - T2). The evaluated outcomes will be: analysis of microstates and spectral analysis of frequencies by EEG; dual task capability with Timed Up and Go (TUG); executive function (Stroop test and verbal fluency test); motor aspects of daily life (MDS UPDRS II). For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, Version 20.0, will be used and statistical significance considered at 5% (p ≤ 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS over M1 and DLPFC | Experimental | Device: Transcranial Direct Current StimulationAnodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC). Duration: 20 minutes; Intensity: 2mA. |
| tDCS over M1 and FPA | Experimental | Device: Transcranial Direct Current StimulationAnodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and left frontal polar area (FPA). Duration: 20 minutes; Intensity: 2mA. |
| tDCS over M1 | Active comparator | Device: Transcranial Direct Current StimulationAnodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of idiopathic PD, issued by a neurologist specializing in movement disorders;
- Disease staging between I and III, according to the modified Hoehn and Yahr scale;
- Regular antiparkinsonian pharmacological treatment;
- Score higher than 24 or 18 (for participants with low education) in the Mini -Mental State Examination
- Ages: 40 - 75 years
Key exclusion criteria (9 listed)
- Diagnosis of atypical parkinsonism;
- Neurological comorbidities;
- History of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation;
- DBS implantation - deep brain stimulation;
- Patients missing two consecutive protocol sessions.
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 |
|---|---|---|
| Transcranial Direct Current StimulationParticipants will receive 16 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, on alternate days (3 times a week). The current will be delivered via saline-embedded sponge surface electrodes using a battery-powered neurostimulator (TCT-Research, Trans Cranial Technologies, Hong Kong). A small active specific electrode (5x5 cm) will be used to prevent coverage of adjacent areas, resulting in a current density of 0.08 mA / cm². The cathode, reference electrode (5x7cm), will be positioned in the occipital region. These parameters are within the safe limits established in previous human studies. | Device | tDCS over M1, tDCS over M1 and DLPFC, tDCS over M1 and FPA |
Primary outcome
Change in EEG microstates
Time frame: Baseline, after 6 weeks, and after 10 weeks
For the analysis of the EEG microstates the following temporal parameters will be considered: the average duration of each microstate; its frequency of occurrence; the fraction of the total recording time covered by each; the overall variation explained by each microstate and the probabilities of transition from one microstate to another. The brain electrical activity will be acquired through the BrainVision actiCHamp equipment using 32 Ag / AgCl electrodes that will be fixed according to the International 10-20 System, keeping the impedance below 10kΩ in silent condition and in eyes open states. and eyes closed. The output of the amplifier data will be directed to a computer with BrainVision Pycoder software to record the obtained records and the data will be processed using the BrainVision Analyzer.
5 secondary outcomes
Spectral analysis of EEG frequencies
Time frame: Baseline, after 6 weeks, and after 10 weeks
Motor aspects of daily life
Time frame: Baseline, after 6 weeks, and after 10 weeks
Stroop test
Time frame: Baseline, after 6 weeks, and after 10 weeks
Dual Task
Time frame: Baseline, after 6 weeks, and after 10 weeks
Verbal Fluency Test
Time frame: Baseline, after 6 weeks, and after 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
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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.
Suellen Andrade principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Parkinson Disease, run by Federal University of Paraíba at 1 site 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 8 inclusion and 9 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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Suellen Andrade (+55 83 999371471, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG microstates (time frame: Baseline, after 6 weeks, and after 10 weeks). 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 4 May 2020.