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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-30

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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 ).

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tDCS over M1 and DLPFC

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

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Participants will receive 15 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, 5 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. These parameters are within the safe limits established in previous human studies.

tDCS over M1 and FPA

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

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Participants will receive 15 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, 5 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. These parameters are within the safe limits established in previous human studies.

tDCS over M1

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

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation

Intervention Type DEVICE

Participants will receive 15 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, 5 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. These parameters are within the safe limits established in previous human studies.

Interventions

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Transcranial Direct Current Stimulation

Participants will receive 15 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, 5 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. These parameters are within the safe limits established in previous human studies.

Intervention Type DEVICE

Other Intervention Names

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tDCS

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No