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

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ClinicalTrials.gov Identifier: NCT04090385
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Suellen Marinho Andrade, Federal University of Paraíba

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Transcranial Direct Current Stimulation Not Applicable

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 16 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 ).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease: Randomized Controlled Trial
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tDCS over M1 and DLPFC
Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC). Duration: 20 minutes; Intensity: 2mA.
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. These parameters are within the safe limits established in previous human studies.
Other Name: tDCS

Experimental: tDCS over M1 and FPA
Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1) and left frontal polar area (FPA). Duration: 20 minutes; Intensity: 2mA.
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. These parameters are within the safe limits established in previous human studies.
Other Name: tDCS

Active Comparator: tDCS over M1
Anodic transcranial direct current stimulation (tDCS) over right primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA.
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. These parameters are within the safe limits established in previous human studies.
Other Name: tDCS




Primary Outcome Measures :
  1. Changes in motor function assessed by the Unified Parkinson's Disease Rating Scale - Part III (UPDRS - III) [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    For this outcome, the Unified Parkinson's Disease Rating Scale - Part III will be used. Section III provides an overall score for movement-related functions and activities (tremor, stiffness, gait, alternating movements, among others). This section is made up of 33 items, which can range from zero (normal) to four (severe), with responses that are linked to commonly accepted clinical terms. The higher the score, the greater the impairment of motor function.

  2. Changes in cognitive function assessed by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool. MoCA is composed of eight cognitive domains, which are scored within a range of 0 to 30 points (higher scores indicate better function): short-term memory; visuospatial skills; executive function; verbal fluency; attention, concentration and working memory; language; sentence repetition; and spatiotemporal orientation.


Secondary Outcome Measures :
  1. Changes in attention and mental flexibility assessed by the Trail Making Test - A and B [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    To assess this outcome, the Trail Making Test - Parts A and B will be used. In condition A, the participant must draw lines, without removing the pencil from the paper, to connect numbers in a sequence. In condition B, the participant must draw lines to connect numbers and letters in an alternating numeric and alphabetic sequence. Prior to the execution of the task, a short "training sheet" is presented from both parts, in which the above instructions are given. The final score represents the total time to finish the task execution. When the participant makes a mistake during the test, the examiner should point out the error at the time of the test and ask the examiner to return to the previous circle and continue the test. Thus, errors are not logged, but result in an increase in total time.

  2. Changes in executive functions and planning assessed by the London Tower Task [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    The Tower of London task is very sensitive to evaluate executive dysfunction in PD patients. The Tower of London is made up of three vertical pins of different heights and three colored spheres, with a hole in the center for the pins to fit. The goal is to move them to reproduce, in a given number of moves, the position of a presented target figure. There are 15 problems with increasing difficulty and reduced possibilities for moving parts. Three attempts to resolve the issue are allowed. Will be evaluated: total and average execution time, and total score, obtained by the sum of the points of each step, ranging from 0 to 3.

  3. Changes in balance assessed by the Mini-BESTest [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    The Mini-BESTest test will be used to evaluate static and dynamic balance in 14 activities. These include TUG (Timed Up and Go), Push and Release Test and gait quality while changing speed, handling obstacles and turning on your own body axis. Each of the 14 items is scored from 0 to 2, with 0 indicating the lowest level of functionality.

  4. Changes in walking speed assessed by 10 Meter Walk Test [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    To evaluate gait speed and cadence will be used the 10 Meter Walk Test (10MWT). A distance of 10 meters will be determined, with 2 meters of initial acceleration and 2 meters for deceleration. Participants will have 3 attempts to travel the distance, walking as fast as possible without running. An average of the time spent during the three attempts will be calculated. Finally, the number of steps will be counted by visual observation.

  5. Changes in quality of life for people with Parkinson's disease assessed by the Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    PDQ-39 is a specific quality of life assessment scale for Parkinson's disease and comprises 39 items that can be answered with five different response options: "never"; "Sometimes"; "sometimes"; "often"; "Always" or "it's impossible for me". The instrument is divided into eight dimensions: Mobility (10 items), Daily Living Activities (6 items), Emotional Wellbeing (6 items), Stigma (4 items), Social Support (3 items), Cognition (4 items) , Communication (3 items) and Body Discomfort (3 items). The total score for each individual is calculated according to the following formula: 100 x (sum of patient scores on 39 questions / 4 x 39). The score of each dimension is obtained in the same way as the total score. A low score indicates better perception of quality of life by the individual.

  6. Changes in the general aspects of the electroencephalogram as a response predictor [ Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up) ]
    The electroencephalogram (EEG) to be used has 32 channels, with silver chloride electrodes, which will be fixed to the scalp through an adjustable cap, following the international EEG 10/20 system, containing holes that will allow the electrode to contact the scalp. The amplifier is ActiChamp, developed by Brain Products Inc., with a 500Hz sampling rate. The high pass 0.5 and low pass 60 Hz filters will be applied at the time of data acquisition to exclude noise in the frequency range above 60 Hz. The right and left mastoid region electrodes will be used as reference at the time of data collection.



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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);
  • Patients missing two consecutive protocol sessions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090385


Contacts
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Contact: Suellen Andrade +55 83 999371471 suellenandrade@gmail.com
Contact: Camila Machado +55 83 996421523 camilamachado60@gmail.com

Locations
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Brazil
Suellen Marinho Andrade Recruiting
João Pessoa, PB, Brazil
Contact: Suellen Andrade       suellenandrade@gmail.com   
Sponsors and Collaborators
Federal University of Paraíba
Investigators
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Principal Investigator: Suellen Andrade Federal University of Paraiba

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Responsible Party: Suellen Marinho Andrade, Principal Investigator and Professor, Federal University of Paraíba
ClinicalTrials.gov Identifier: NCT04090385     History of Changes
Other Study ID Numbers: NeuroPark
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases