Effects of tDCS Combined With Therapeutic Exercises in Patients With Parkinson's Disease.

April 30, 2021 updated by: Alessandra Tanuri Magalhães

Effects of Transcranial Direct Current Stimulation Combined With Therapeutic Exercises in Patients With Parkinson's Disease: Randomized Clinical Trial

Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Therapeutic exercises are widely employed in the attempt to delay or minimize disease progression, characterized by significant motor and sensory deficits. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (TDCs) as a complement to therapeutic exercises. However, few studies have investigated the effects of TDCs combined with therapeutic exercises in patients with Parkinson's disease. This study aims to investigate the effect of TDCs combined with therapeutic exercises in people with Parkinson's disease. Thirty patients will be randomized into two distinct groups to receive either TDCs(anodal) + therapeutic exercises or TDCs (sham) + therapeutic exercises for 24 sessions over a five-week period. The primary clinical outcome (balance) and secondary outcomes (functional capacity, quality of life and perception of overall effect) will be collected before treatment after two and five weeks at month 3 and month 6 after randomization. The data will be collected by a blind examiner to the treatment allocation.

Study Overview

Status

Status

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

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

In this study, a randomized, double-blind, placebo-controlled experimental design will be used. The 30 participants will be randomized into two groups: (1) TDCs(anodal) + therapeutic exercises and (2) TDCs (sham) + therapeutic exercises. The treatment will be performed for 8 weeks, with three sessions per week, totaling 24 sessions of electrostimulation and therapeutic exercises. The primary variable (balance), secondary outcomes and other outcomes will be assessed before and after treatment. Follow-up of patients will be conducted at 8, 12 and 24 weeks after randomization. All evaluations will be performed by a single researcher who, like the patients, will not know which stimulation group will be participating. Patients diagnosed with Parkinson's who seek treatment at the Clinical School of Physiotherapy of the Federal University of Piauí will receive detailed instructions on the present study. The physiotherapist responsible for evaluations will explain the objectives of the study, possible treatments, eligibility criteria and potential risks arising from the application of brain stimulation and therapeutic exercises. Patients who agree to the conditions and sign the consent form may participate in the study. Participants who meet the eligibility criteria will be included in the study.

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 (Actual)

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.
30

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.
  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Brazil
    • PI
      • Parnaíba, PI, Brazil, 64202020
        • Universidade Federal do Piauí

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

46 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • medical diagnosis of idiopathic Parkinson's disease present for at least 12 months,
  • spontaneous demand for treatment,
  • in clinical follow-up and pharmacological treatment by a responsible physician,
  • Parkinson's classification of 1.5-3 according to the Hoehn and Yahr scale,
  • absence of cardiovascular diseases and musculoskeletal,
  • signing of the free and informed consent form.

Exclusion Criteria:

  • Use any associated orthopedic device to aid gait or balance control,
  • signs of severe dementia (evaluated by the Mini-Mental State Examination - MMSE),
  • diagnosis of other neurological disorders (including those of central and peripheral nature)
  • previous treatment with tDCS,
  • medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants)
  • the use of pacemakers or other implanted devices.

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: Double

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: anodal tDCS +Exercise Therapy
Anodal tDCS (2mA of intensity, for twenty minutes) over the motor cortex representation of trunk and lower limbs. Immediately after tDCS application all the patients will participate in an exercise therapy protocol involving balance control, strength,
Device: tDCS
Transcranial direct current stimulation is a modulation technique of neuronal excitability which has very promising results in Parkinson's disease. In addition to the possibility of increasing the excitability of areas to tDCS, it can also facilitate the execution of the exercises by increasing the excitability of the primary motor cortex and changing the recruitment strategies of the motor units.
Other Names:
  • non invasive brain stimulation
Behavioral: Exercise Therapy
Therapeutic exercises will be based on the literature (O'Sullivan and Schmitz 2004, Klamroth et al 2016, Reynolds et al., 2016, Pérez et al 2016, Smania et al., 2010, Pastor et al., 1993, Traub et al., 1980, Schoneburg et al., 2013) Each session will be divided into warm-up exercises; balance and relaxation, with a duration of 50 minutes and a frequency of 3 times a week. Training progresses and intensifies every two weeks. The subjects will perform five repeated movements of each exercise, evolving according to the condition of each patient (according to the Hoehn and Yahr staging scale).
Other Names:
  • Physiotherapy
Sham Comparator: Sham tDCS+ Exercise Therapy
Anodal tDCS (2mA of intensity, for twenty minutes but thirdy seconds ON) over the motor cortex representation of trunk and lower limbs.
Device: tDCS
Transcranial direct current stimulation is a modulation technique of neuronal excitability which has very promising results in Parkinson's disease. In addition to the possibility of increasing the excitability of areas to tDCS, it can also facilitate the execution of the exercises by increasing the excitability of the primary motor cortex and changing the recruitment strategies of the motor units.
Other Names:
  • non invasive brain stimulation
Behavioral: Exercise Therapy
Therapeutic exercises will be based on the literature (O'Sullivan and Schmitz 2004, Klamroth et al 2016, Reynolds et al., 2016, Pérez et al 2016, Smania et al., 2010, Pastor et al., 1993, Traub et al., 1980, Schoneburg et al., 2013) Each session will be divided into warm-up exercises; balance and relaxation, with a duration of 50 minutes and a frequency of 3 times a week. Training progresses and intensifies every two weeks. The subjects will perform five repeated movements of each exercise, evolving according to the condition of each patient (according to the Hoehn and Yahr staging scale).
Other Names:
  • Physiotherapy

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
Change From balance
Time Frame: 8 weeks after randomization
Balance will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) and Mediolateral (ML) axes in centimeters. Other variables such as area (cm²), speed AP and ML(cm/s), frequency (Hz) and Entropy (no unit) will be derived from COP displacement.
8 weeks after randomization

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
Change From balance
Time Frame: 3 and 6 months after randomization
Balance will be evaluated using a force plate to record center of pressure displacement (COP) in antero-posterior (AP) and Mediolateral (ML) axes in centimeters. Other variables such as area (cm²), speed AP and ML(cm/s), frequency (Hz) and Entropy (no unit) will be derived from COP displacement.
3 and 6 months after randomization
Change From Unified Parkinson´s Disease Rating Scale
Time Frame: 8 weeks, 3 and 6 months after randomization
The Unified Parkinson's Disease Rating evaluate is composed of 42 questions, divided into 4 parts: motor symptoms; mental activity, behavior and mood; activities of daily living; complications of drug therapy. The mental activity, behavior and humor part counts of 4 questions being the score ranging from 0 to 4 totaling 16 points. The daily life activity part consists of 13 questions that range from 0 to 4 scores totaling 52 points. The motor symptoms part consists of 14 questions, in which some of them have to be applied independently for each member. Thus, there are 27 observations that vary the score from 0 to 4, totaling 108 points. Part of the complications of drug therapy consists of 23 questions in which 4 vary the score from 0 to 4 and 7 questions vary the score from 0 to 1 totaling 23 points. Thus, the scoring of this scale varies between 0 and 199 in that the higher the score the greater the impairment and the closer to zero the more tendency to normality
8 weeks, 3 and 6 months after randomization
Change From Parkinson Disease Quality of Life
Time Frame: 8 weeks, 3 and 6 months after randomization
Parkinson Disease Quality of Life is a questionnaire consists of 37 items, subdivided into four domains: parkinsonian symptoms (14 items), systemic symptoms (7 items), emotional function (7 items) social function (9 items). The score ranges from 1 (all time), 2 (almost always), 3 (sometimes), 4 (few times) and 5 (never). The score of each domain is determined by the average of the points of each domain. The sum of the average score of each domain is made and high scores refers to the individual's better perception regarding his or her quality of life.
8 weeks, 3 and 6 months after randomization
Change in the perception scale of the overall effect
Time Frame: 8 weeks, 3 and 6 months after randomization
Perception scale of the overall effect evaluates the level of perception of recovery of the patient in relation to the treatment comparing the beginning of the symptoms with the last days. It is a numerical scale of 11 points ranging from -5 to +5, being - 5: extremely worse; zero: no modification; and +5: fully recovered, with the highest score representing greater recovery
8 weeks, 3 and 6 months after randomization
Maximal Isometric Voluntary Contraction
Time Frame: 8 weeks, 3 and 6 months after randomization
Peak and average force (Kg or Newton) and time to peak (seconds) will be collected during the maximal Isometric contraction of knee extensor muscles.
8 weeks, 3 and 6 months after randomization
Tampa Scale for Kinesiophobia (TSK)
Time Frame: 8 weeks, 3 and 6 months after randomization
Irrational, and debilitating fear of movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Its a 17-item scale.
8 weeks, 3 and 6 months after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geriatric Depression Scale (GDS)
Time Frame: 8 weeks, 3 and 6 months after randomization
Assessment of emotional function with GDS. Its a 15 item scale
8 weeks, 3 and 6 months after randomization

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.
Alessandra Tanuri Magalhães

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Foundation for Research Support of the State of Piauí

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.
February 1, 2018

Primary Completion (Actual)

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.
December 1, 2019

Study Completion (Actual)

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.
January 15, 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).
February 7, 2018

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.
March 20, 2018

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.
March 22, 2018

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.
May 3, 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.
April 30, 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.
April 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 2.085.438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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