The Impact tDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease

October 5, 2020 updated by: Suellen Marinho Andrade, Federal University of Paraíba

Can Task Specificity and Baseline Outcomes Impact tDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease? A Protocol for a Pilot Randomized Controlled Trial

This study is a group controlled clinical trial. Parallel study, patients aged 40-70 years, with Parkinson disease. Twelve sessions, three times a week, for 30 minutes, simultaneously to the rehabilitation program. Training will consist of Transcranial Direct Current Stimulation linked dual-task exercises or dual-taks exercises with cognitive training, applied three times a week during four weeks. The investigators will used instruments: dual-task gait speed (Auditory Stroop Task ), executive function (Wisconsin Card Sorting Test , Auditory Stroop Test, Trail Making Test, Verbal Fluency Test and Montreal Cognitive Assessment), and, the objective is to examine task-dependency in enhancing the effects of tDCS-linked rehabilitation training on PD and the relationships between baseline outcomes in responders and non-responders to therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Patients with Parkinson's disease have difficulty performing a dual-task, a condition present in everyday life. It is possible that strategies such as Transcranial Direct Current Stimulation can be associated with motor training enriched with dual-task and cognitive training to improve the performance of two concurrent tasks. It is currently unclear whether specific tasks and clinical conditions of PD patients have different results after the intervention. Therefore, the proposed randomized controlled trial will examine task-dependency in enhancing the effects of tDCS-linked rehabilitation training on PD and the relationships between baseline outcomes in responders and non-responders to therapy.

Discussion: This study will evaluate the effectiveness of an intervention protocol with transcranial direct current stimulation, dual-task training and cognitive training in patients with Parkinson's disease. The study will also highlight whether the clinical factors and variability between individuals that could interfere in the training of a specific task and influence the therapeutic effect.

Study Type

Interventional

Enrollment (Anticipated)

242

Phase

  • 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

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

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • being diagnosed with idiopathic Parkinson's disease by a neurologist based on definitive evidence of responsiveness to levodopa at the start of the disease and the history of progressive hypokinesia with asymmetric onset. PD will be diagnosed based on Parkinson's Disease Society Brain Bank (PDSBB) criteria, as described in Hughes et al.
  • age between 40 and 70 years, with no distinction for sex, schooling level or other sociodemographic characteristics
  • disease staging between 1.5 and 3, according to the modified Hoehn and Yahr scale
  • undergoing regular pharmacological treatment with levodopa (equivalent dose > 300mg) or taking antiparkinsonian medication such as anticholinergics, selegiline, dopamine agonists (amantadine) and COMT (catechol-O-methyl transferase) inhibitors
  • score of more than 24 points on the Mini-Mental State Examination
  • not exhibiting other associated neurological diseases and no musculoskeletal and/or cardiorespiratory changes that could compromise gait.

Exclusion Criteria:

  • be diagnosis of atypical Parkinson's disease
  • neuropsychiatric comorbidities; convulsions, metal clips and/or pacemaker; deep brain stimulation implant; history of epilepsy; neurosurgery; traumatic brain injury; alcohol abuse or drug dependency;
  • associated diseases of the peripheral or central nervous system
  • undergoing physical therapy at another location
  • inability to walk 10 meters
  • presence of important dyskinesia that prevents the participant from sitting in a chair
  • abnormal and persistent increase in systemic blood pressure before or during training, after 3 measurements taken 5 minutes apart - Cut-off: systolic blood pressure ≥ 140 mm Hg and/or diastolic ≥ 90 mm Hg
  • not understanding any of the training protocol stages
  • chemical scalp treatment within the previous 30 days, and experiencing severe pain and/or discomfort that precludes performing the proposed activities.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active group
In the group G1 will be administered: tDCS active + dual-task motor training + cognitive training.
Other: Cognitive training
Both groups will undergo the motor training where only the type of received electric current is varied (active or simulated sham type) associated cognitive training. The twelve sessions will be performed in three sessions per week for 30 minutes.
Other Names:
  • tDCS active
Sham Comparator: Sham group
In the group G2 will be administered: tDCS active + dual-task motor training
Other: Cognitive training
Both groups will undergo the motor training where only the type of received electric current is varied (active or simulated sham type) associated cognitive training. The twelve sessions will be performed in three sessions per week for 30 minutes.
Other Names:
  • tDCS active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes dual-task gait speed by the Auditory Stroop Task
Time Frame: [Baseline, after 04 weeks]
For this outcome, the Auditory Stroop Task participants will be asked to walk while listening to words spoken loudly and softly and indicate if the volume heard was loud or low, irrespective of the word pronounced.
[Baseline, after 04 weeks]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in executive functions assessed by Wisconsin Card Sorting Test (WCST)
Time Frame: [Baseline, after 04 weeks]
The Wisconsin Card Sorting Test (WCST) is a neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement. A number of stimulus cards are presented to the participant. The participant is told to match the cards, but not how to match; however, they are told whether a particular match is right or wrong. The original WCST used paper cards and was carried out with the experimenter on one side of the desk facing the participant on the other. The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors.
[Baseline, after 04 weeks]
Changes in executive functions assessed by Trail Making Test (TMT)
Time Frame: [Baseline, after 04 weeks]
The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning
[Baseline, after 04 weeks]
Changes in executive functions assessed by Verbal Fluency Test
Time Frame: [Baseline, after 04 weeks]
The Verbal Fluency Test are a kind of psychological test in which participants have to produce as many words as possible from a category in a given time (usually 60 seconds). This category can be semantic, including objects such as animals or fruits, or phonemic, including words beginning with a specified letter, such as p, for example
[Baseline, after 04 weeks]
Changes in executive functions assessed by Montreal Cognitive Assessment (MoCA)
Time Frame: [Baseline, after 04 weeks]
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 04 weeks]
Changes in motor functions assessed by Dynamic Gait Index (DGI)
Time Frame: [Baseline, after 04 weeks]
The Dynamic Gait Index (DGI) assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function (total score = 24).
[Baseline, after 04 weeks]
Changes in motor functions assessed by 10-meter walk test
Time Frame: [Baseline, after 04 weeks]
The 10-meter walk test to estimate gait speed by recording the average time the patient takes to cover a distance of 10m in three attempts
[Baseline, after 04 weeks]
Changes in motor functions assessed by Timed Up and Go (TUG) test
Time Frame: [Baseline, after 04 weeks]
The Timed Up and Go (TUG) test to stand up from a chair at the command, walk 3 meters walk along a demarcated course, turn around and walk back to the chair, then sit down.
[Baseline, after 04 weeks]
Changes in motor functions assessed by Kinematics of Gait
Time Frame: [Baseline, after 04 weeks]
To analyze movement using the Qualisys Motion Capture System (Qualisys Medical AB, 411 13, Gothenburg, Sweden);
[Baseline, after 04 weeks]
Changes in motor function assessed by the Unified Parkinson's Disease Rating Scale - Part III (UPDRS - III)
Time Frame: [Baseline, after 04 weeks]
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 04 weeks]
Changes in motor function assessed by Activities-specific balance confidence (ABC) scale
Time Frame: [Baseline, after 04 weeks]
For this outcome, Activities-specific balance confidence (ABC) scale to measure the level of confidence in performing daily activities, in addition to identifying fear of falling and possible social isolation
[Baseline, after 04 weeks]

Collaborators and Investigators

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

Sponsor

Federal University of Paraíba

Collaborators

Universidade Federal do Rio Grande do Norte

Investigators

  • Principal Investigator: Suellen Suellen Andrade, Federal University of Paraíba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCSparkinson

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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