Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04581590

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Paraíba

João Pessoa, Paraíba, 58051-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Training

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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).

  6. 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

  7. 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.

  8. 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);

  9. 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.

  10. 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

  11. Changes in sleep quality assessed by Parkinson's disease sleep scale-2 (PDSS-2)

    Time frame: Time Frame: [Baseline, after 04 weeks]

    The PDSS is a scale specifically designed to assess sleep quality in individuals with Parkinson's. The PDSS-2 consists of 15 questions rated according to five categories ranging from 0 (never) to 4 (very frequent). Its total score ranges from 0 (no disturbance) to 60 (maximum nighttime disturbance).

  12. Changes in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Time Frame: [Baseline, after 04 weeks]

    The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.

  13. Changes in daytime sleepiness assessed by the Epworth Sleepiness Scale (ESS)

    Time frame: Time Frame: [Baseline, after 04 weeks]

    The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Collaborators

  • Universidade Federal do Rio Grande do Norte

Registry information

Official study title

Can Task Specificity and Baseline Outcomes Impact TDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease? a Protocol for a Controlled, Double-blind, Randomized Multicentric Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Oct 9, 2020
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.