Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients
1 other identifier
interventional
60
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 6, 2020
CompletedFirst Posted
Study publicly available on registry
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMay 4, 2020
April 1, 2020
11 months
January 6, 2020
April 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, after 6 weeks, and after 10 weeks
Secondary Outcomes (5)
Spectral analysis of EEG frequencies
Baseline, after 6 weeks, and after 10 weeks
Motor aspects of daily life
Baseline, after 6 weeks, and after 10 weeks
Stroop test
Baseline, after 6 weeks, and after 10 weeks
Dual Task
Baseline, after 6 weeks, and after 10 weeks
Verbal Fluency Test
Baseline, after 6 weeks, and after 10 weeks
Study Arms (3)
tDCS over M1 and DLPFC
EXPERIMENTALAnodic 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
EXPERIMENTALAnodic 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 COMPARATORAnodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- Sex: All
- Subjects who do not have self-report of neurodegenerative disorders
You may not qualify if:
- 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.
- History of epilepsy;
- Metallic implants in the head;
- Clinical evidence of brain injury.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suellen Marinho Andrade
João Pessoa, Paraíba, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suellen Andrade
Federal University of Paraiba
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator and Teacher
Study Record Dates
First Submitted
January 6, 2020
First Posted
January 9, 2020
Study Start
December 1, 2019
Primary Completion
November 1, 2020
Study Completion
January 1, 2021
Last Updated
May 4, 2020
Record last verified: 2020-04