Clinical trial NCT04221659: Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients
Official title: Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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:

* History of epilepsy;
* Metallic implants in the head;
* Clinical evidence of brain injury.

Primary outcomes:
measure: Change in EEG microstates
timeFrame: Baseline, after 6 weeks, and after 10 weeks
Secondary outcomes:
measure: Spectral analysis of EEG frequencies
timeFrame: Baseline, after 6 weeks, and after 10 weeks
measure: Motor aspects of daily life
timeFrame: Baseline, after 6 weeks, and after 10 weeks
measure: Stroop test
timeFrame: Baseline, after 6 weeks, and after 10 weeks
measure: Dual Task
timeFrame: Baseline, after 6 weeks, and after 10 weeks
measure: Verbal Fluency Test
timeFrame: Baseline, after 6 weeks, and after 10 weeks
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Marinho Andrade
state: PB
Study officials:
affiliation: Federal University of Paraiba
name: Suellen Andrade
role: PRINCIPAL_INVESTIGATOR
References: