NCT04221659

Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients

Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients: Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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).

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Transcranial Direct Current Stimulation	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-11-01
• Completion: 2021-01-01
• First posted: 2020-01-09
• Last updated: 2020-05-04

Locations

1 site across 1 country: Brazil