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

February 13, 2021 updated by: Suellen Marinho Andrade, Federal University of Paraíba

Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease: Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 ).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Brazil
    • PB
      • João Pessoa, PB, Brazil
        • Recruiting
        • Suellen Marinho Andrade

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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.
Other Names:
  • tDCS
Experimental: 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.
Device: 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.
Other Names:
  • tDCS
Active Comparator: tDCS over M1
Anodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA.
Device: 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.
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, after 6 weeks, and after 10 weeks (follow-up)
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.
Baseline, after 6 weeks, and after 10 weeks (follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, after 6 weeks, and after 10 weeks (follow-up)
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.
Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in working memory assessed by the Digit Span Forward and Backward Test
Time Frame: Baseline, after 6 weeks, and after 10 weeks (follow-up)
The Digit Span Forward (DSF) is related to the efficiency of attention, while the Digit Span Backward (DSB), the performance of working memory. Both tests involve six pairs of random numeric sequences that the examiner reads aloud at the rate of one per second. During the DSF the participant will have to repeat each sequence of numbers exactly as they were given, while in the DSB they have to repeat each sequence of numbers in the reverse order. When a sequence is repeated correctly, the examiner reads the next one continuing until the subject fails in a set of sequences or repeats the highest sequence correctly. For each digit repeated correctly, one point is given.
Baseline, after 6 weeks, and after 10 weeks (follow-up)
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.
Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in gait 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.
Baseline, after 6 weeks, and after 10 weeks (follow-up)
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.
Baseline, after 6 weeks, and after 10 weeks (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NeuroPark

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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