Parkinson DiseaseNCT04090385
Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease
A study testing Transcranial Direct Current Stimulation in people with Parkinson Disease, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jan 2020to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Suellen Marinho Andrade
João Pessoa, Paraíba
Suellen Andrade, suellenandrade@gmail.com
About this study
Official title: 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.
Read the 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 ).
- Conditions
- Parkinson Disease
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS over M1 and DLPFC | Experimental | Anodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC). Duration: 20 minutes; Intensity: 2mA. Receives: Device: Transcranial Direct Current Stimulation |
| tDCS over M1 and FPA | Experimental | Anodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left frontal polar area (FPA). Duration: 20 minutes; Intensity: 2mA. Receives: Device: Transcranial Direct Current Stimulation |
| tDCS over M1 | Active comparator | Anodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 6 weeks, and after 10 weeks (follow-up)
Changes in cognitive function assessed by the 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 6 weeks, and after 10 weeks (follow-up)
Secondary outcomes (6)
Changes in attention and mental flexibility assessed by the Trail Making Test - A and B
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.
Measured: Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in executive functions and planning assessed by the London Tower Task
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.
Measured: Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in working memory assessed by the Digit Span Forward and Backward Test
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.
Measured: Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in balance assessed by the Mini-BESTest
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.
Measured: Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in gait speed assessed by 10 Meter Walk Test
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.
Measured: 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)
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.
Measured: Baseline, after 6 weeks, and after 10 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start30 Jan 2020
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Marinho Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090385
- Sponsor's protocol ID
- NeuroPark
- Status last verified
- Feb 2021
- First submitted
- 12 Sep 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04090385
- Acronym / sponsor ID
- NeuroPark
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS over M1 and DLPFC | Experimental | Device: Transcranial Direct Current StimulationAnodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC). Duration: 20 minutes; Intensity: 2mA. |
| tDCS over M1 and FPA | Experimental | Device: Transcranial Direct Current StimulationAnodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left frontal polar area (FPA). Duration: 20 minutes; Intensity: 2mA. |
| tDCS over M1 | Active comparator | Device: Transcranial Direct Current StimulationAnodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCSParticipants 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. | Device | tDCS over M1, tDCS over M1 and DLPFC, tDCS over M1 and FPA |
Primary outcome
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.
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.
6 secondary outcomes
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)
Changes in executive functions and planning assessed by the London Tower Task
Time frame: 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)
Changes in balance assessed by the Mini-BESTest
Time frame: 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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suellen Andrade principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Parkinson Disease, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Feb 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suellen Andrade (+55 83 999371471, suellenandrade@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2021.