Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease

Federal University of Paraíba

Status: Unknown

Conditions: Parkinson Disease

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04090385

NeuroPark

Details and patient eligibility

About

People with Parkinson's disease (PD) experience various motor and nonmotor symptoms throughout its evolution. It is characterized mainly by the presence of tremor, stiffness, bradykinesia and postural instability, leading to progressive functional limitation and impairment in the performance of usual activities of daily living. In addition, patients may have cognitive disorders, memory deficits, problems related to visuospatial dysfunction, difficulties in performing sequential or repetitive movements, freezing, and slow psychological responses. Previous studies analyzed by systematic reviews suggest the efficacy of Transcranial Direct Current Stimulation (tDCS) to improve the motor and non-motor symptoms of PD, depending on the area of stimulation. However, most of these focus only on one specific area. Therefore, the overall objective of this study is to investigate the effects of multifocal neuromodulation on the motor and cognitive function of people with Parkinson's disease.

Full description

For this, a randomized, triple-blind clinical trial will be conducted with 60 people with PD, recruited from the reference centers in neurology and physiotherapy in João Pessoa. After recruitment of participants, they will be randomized into three groups: Group 1 - tDCS over Primary motor cortex (M1) + Dorsolateral prefrontal cortex (DLPFC); Group 2 - tDCS over Primary motor cortex + Frontal polar area (FPA); Group 3 - tDCS over Primary motor cortex. In each condition, an initial baseline assessment (T0) will be performed after 15 treatment sessions (T1) and 30 days after the end of the protocol (Follow-up Assessment - T2), during which time participants will not receive any type of treatment. The outcomes evaluated will be: Motor and cognitive function, executive functions, attention and planning, balance, gait speed an quality of life. For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, version 20.0, will be used and considered significant, an alpha value of 5% (p <0.05 ).

Enrollment: 45 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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;
• Be using antiparkinsonian medication regularly;
• Score higher than 24 or 18 (for participants with low education), verified through the Mini Mental State Examination.

Exclusion criteria

• Diagnosis of atypical parkinsonism;
• Neurological comorbidities;
• History of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation;
• Previous surgical intervention for PD (DBS implantation - deep brain stimulation);
• Presence of severe freezing episodes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups

tDCS over M1 and DLPFC

Experimental group

Description:

Anodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC). Duration: 20 minutes; Intensity: 2mA.

Treatment:

Device: Transcranial Direct Current Stimulation

tDCS over M1 and FPA

Experimental group

Description:

Anodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left frontal polar area (FPA). Duration: 20 minutes; Intensity: 2mA.

Treatment:

Device: Transcranial Direct Current Stimulation

tDCS over M1

Active Comparator group

Description:

Anodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA.

Treatment:

Device: Transcranial Direct Current Stimulation