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Parkinson DiseaseNCT04581590

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

A study testing Cognitive training in people with Parkinson Disease and Cognition Disorder, run by Federal University of Paraíba at 1 site in Brazil.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 70 years
What is being tested?
Cognitive training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
1 siteBrazil
Study dates
3 Oct 2022to 2 Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Federal University of Paraíba

    João Pessoa, Paraíba, 58051-900

Other trials in Brazil

About this study

Official 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

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.

Read the 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.

Being tested
Cognitive training
Medical subject headings
Parkinson Disease, Cognition Disorders, Motor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive trainingOther

    Also called tDCS active

    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.

Study groups in NCT04581590
Study groupRoleWhat they receive
Active groupActive comparatorIn the group G1 will be administered: tDCS active + dual-task motor training + cognitive training.
Receives: Other: Cognitive training
Sham groupSham comparatorIn the group G2 will be administered: tDCS active + dual-task motor training
Receives: Other: Cognitive training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes dual-task gait speed by the Auditory Stroop Task

    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.

    Measured: [Baseline, after 04 weeks]

Secondary outcomes (13)
  1. Changes in executive functions assessed by Wisconsin Card Sorting Test (WCST)

    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.

    Measured: [Baseline, after 04 weeks]

  2. Changes in executive functions assessed by Trail Making Test (TMT)

    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

    Measured: [Baseline, after 04 weeks]

  3. Changes in executive functions assessed by Verbal Fluency Test

    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

    Measured: [Baseline, after 04 weeks]

  4. Changes in executive functions assessed by Montreal Cognitive Assessment (MoCA)

    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.

    Measured: [Baseline, after 04 weeks]

  5. Changes in motor functions assessed by Dynamic Gait Index (DGI)

    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).

    Measured: [Baseline, after 04 weeks]

  6. Changes in motor functions assessed by 10-meter walk test

    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

    Measured: [Baseline, after 04 weeks]

  7. Changes in motor functions assessed by Timed Up and Go (TUG) test

    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.

    Measured: [Baseline, after 04 weeks]

  8. Changes in motor functions assessed by Kinematics of Gait

    To analyze movement using the Qualisys Motion Capture System (Qualisys Medical AB, 411 13, Gothenburg, Sweden);

    Measured: [Baseline, after 04 weeks]

  9. Changes in motor function assessed by the Unified Parkinson's Disease Rating Scale - Part III (UPDRS - III)

    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.

    Measured: [Baseline, after 04 weeks]

  10. Changes in motor function assessed by Activities-specific balance confidence (ABC) scale

    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

    Measured: [Baseline, after 04 weeks]

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

    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).

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

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

    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.

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

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

    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'.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2020
  2. Study start3 Oct 2022
  3. Primary completion15 Jul 2024
  4. Study completion2 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a sham-controlled, double-blind randomized multicentric clinical trial will analyze patients with a confirmed diagnosis of Parkinson disease who were subjected to tDCS associated with dual-task motor training and cognitive tranining
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04581590
Sponsor's protocol ID
tDCSparkinson
Status last verified
Jan 2025
First submitted
31 Aug 2020
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Costa-Ribeiro A, Andrade SMMDS, Ferrer MLV, Silva OAPD, Salvador MLS, Smaili S, Lindquist ARR. Can Task Specificity Impact tDCS-Linked to Dual Task Training Gains in Parkinson's Disease? A Protocol for a Randomized Controlled Trial. Front Aging Neurosci. 2021 Jul 1;13:684689. doi: 10.3389/fnagi.2021.684689. eCollection 2021.

    PubMed 34276344

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive training in people with Parkinson Disease and Cognition Disorder, run by Federal University of Paraíba at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes dual-task gait speed by the Auditory Stroop Task (time frame: [Baseline, after 04 weeks]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04581590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

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