Clinical trial NCT04090385: Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease
Official title: Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease: 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: 2019-09-16
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 ).

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;
* 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.

Primary outcomes:
measure: Changes in motor function assessed by the Unified Parkinson's Disease Rating Scale - Part III (UPDRS - III)
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
measure: Changes in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
Secondary outcomes:
measure: Changes in attention and mental flexibility assessed by the Trail Making Test - A and B
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
measure: Changes in executive functions and planning assessed by the London Tower Task
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
measure: Changes in working memory assessed by the Digit Span Forward and Backward Test
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
measure: Changes in balance assessed by the Mini-BESTest
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
measure: Changes in gait speed assessed by 10 Meter Walk Test
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
measure: Changes in quality of life for people with Parkinson's disease assessed by the Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
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: