Parkinson DiseaseNCT06145776
The Role of EEG in Identifying Cognitive Changes in Parkinson's Disease
A study testing tDCS + tredmill training (Standart trehab training) and Cognitite-motor Dual Task Training (DT training) in people with Parkinson Disease and Cognition Disorder, run by Federal University of Paraíba at 2 sites in Brazil.
Trial summary
This study is a group controlled clinical trial. Parallel study, patients aged 40-80 years, with Parkinson disease. Twelve sessions, three times a week, for 30 minutes. Training will consist of Transcranial Direct Current Stimulation linked to tredmill training, in 3 blocks of 7 minutes, and adicionally to the… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Cognition Disorder, EEG With Abnormally Slow Frequencies
- What is being tested?
- tDCS + tredmill training (Standart trehab training) and Cognitite-motor Dual Task Training (DT training)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesBrazil
- Study dates
- 2 Aug 2023to Apr 2024
- 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 80 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. (1992)
- 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 (Hoehn and Yahr, 1998);
- undergoing regular pharmacological treatment with levodopa (equivalent dose > 300 mg) or taking antiparkinsonian medication, such as anticholinergics, selegiline, dopamine agonists, and COMT (catechol-O-methyl transferase) inhibitors for at least 4 weeks prior intervention;
- score of more than 24 points on the Mini-Mental State Examination (Folstein et al., 1975);
- not exhibiting other associated neurological diseases; and
- no musculoskeletal and/or cardiorespiratory changes that could compromise gait.
Who cannot join
- 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;
Show all 13Show fewer
- 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 three measurements taken 5 min apart-Cut-off: systolic blood pressure ≥ 140 mm Hg and/or diastolic ≥ 90 mm Hg (Malachias et al., 2016);
- 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
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Federal University of Paraiba
João Pessoa, Paraíba, 51051900
Suellen M Marinho dos Santos Andrade, Doctor, 83993812744 ext. +55, suellen.andrade@academico.ufpb.br
E
- Recruiting
Aging and Neuroscience Studies Laboratory
João Pessoa
Suellen Andrade
About this study
Official title: Effects of Cognitive-motor Dual-Task Training and tDCS on Brain Electrical Activity Assessed by EEG and Cognitive Performance in Patients With Parkinson's Disease: a Randomized, Double-blind, Controlled Clinical Trial.
This study is a group controlled clinical trial. Parallel study, patients aged 40-80 years, with Parkinson disease. Twelve sessions, three times a week, for 30 minutes. Training will consist of Transcranial Direct Current Stimulation linked to tredmill training, in 3 blocks of 7 minutes, and adicionally to the Experimental Group, dual-task cognitive-motor exercises, simultaneously. The investigators will use the folowwing instruments: Auditory Stroop Test, Trail Making Test, Montreal Cognitive Assessment, Timed-up-and-go ST and DT, UPDRS II and III and Eletroencefalography (EEG). The objective is to examine cognitive alterations on PD pacients due to intervention and the relationships between baseline outcomes in responders and non-responders to therapy.
Read the detailed description
Background: Parkinson disease (PD) is one of the most common age-related brain disorders. PD is defined primarily as a movement disorder, with the typical symptoms being resting tremor, rigidity, bradykinesia and postural instability. In addition to the defining dopamine-related motor symptoms, however, PD is increasingly recognized as a heterogeneous multisystem disorder involving other neurotransmitter systems, such as the serotonergic, noradrenergic and cholinergic circuits. Thus, a wide variety of nonmotor symptoms (NMS) linked with these neurotransmitters are commonly observed in patients with PD. Cognitive decline is among the most common and important NMS. Robust evidence indicates that in comparison with age-matched groups without PD, people with PD exhibit more rapid decline in a number of cognitive domains - in particular, executive, attentional and visuospatial domains, but also memory. In recent years, research has focused on the pre-dementia stages of cognitive impairment in PD, including mild cognitive impairment (MCI). Several longitudinal studies have shown that MCI is a harbinger of dementia in PD, although the course is variable, and stabilization of cognition - or even reversal to normal cognition - is not uncommon. A variety of biomarkers have been studied, some using novel structural and functional imaging techniques, and have documented in vivo brain changes associated with cognitive impairment. 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 the effects of a intervention protocol on brain eletric activity and cognitive outcomes on PD patientes 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 motor-cognitive training in patients with Parkinson's disease. The study will also highlight whether, by qEEG analysis, the clinical factors and variability between individuals that could interfere in the efficacy intervention and influence the therapeutic effect.
- Being tested
- tDCS + tredmill training (Standart trehab training), Cognitite-motor Dual Task Training (DT training)
- Keywords
- Parkinson; EEG; cognition; dual-task cost
- Medical subject headings
- Parkinson Disease, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS + tredmill training (Standart trehab training)Other
Standart Rehab training will consist in 20 min treadmill gait training associated to active atDCS F3 2mA for 20 min.
Cognitite-motor Dual Task Training (DT training)Other
The dual-task training protocol (DT) will consist in cognitive exercises (verbal fluency, mental screening tasks, discrimination, decision-making and reaction time tasks) and motor exercises (walking while carrying a tray with only one empty glasscarrying a glass while walks, change peaces from one pocket to another, looking from one side to another while walking)
| Study group | Role | What they receive |
|---|---|---|
| dual-task group | Experimental | Dual-Task Training Protocol (DTTP) The dual-task training protocol (DT) will consist in cognitive exercise categories: verbal fluency, mental screening tasks, discrimination, decision-making and reaction time tasks, which will be associated to treadmill gait training (Sousa et al., 2016). Verbal commands will focus on the following: (1) large strides; (2) heel strike; (3) raising the knees while walking (Kelly et al., 2012). Receives: Other: tDCS + tredmill training (Standart trehab training); Other: Cognitite-motor Dual Task Training (DT training) |
| control group | Active comparator | The participants will perform 21 min treadmill gait training associated to tDCS active in F3 for 20 min, 3 times a week for 4 weeks. Receives: Other: tDCS + tredmill training (Standart trehab training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG outcomes
PSD of theta, alpha and beta and alpha/theta ratio and beta/theta ratio of 6 ROIs (righ and left: frontal, temporoparietal and occipital)
Measured: 30 days
clinic outcome
Dual-task cost
Measured: 30 days
Secondary outcomes (5)
Total Montreal Cognitive Assessment (MoCA)
total score obtained at Montreal Cognitive Assesment, for a possible maximum of 30 points. A final total score of 26 and above is considered normal.
Measured: 30 days
domains of MoCA
Score of ecah subscale obtained at Montreal Cognitive Assesment: visuospatial/executive (5 points); nomination (3 points); memory (5 points for delayed recall); attention (6 points); language (3 points); abstraction (2 points); and orientation (6 points).
Measured: 30 days
Trail Making Test part B (TMT-B)
TMT-B is scored based on how long it takes to complete the test, within 5 minutes.
Measured: 30 days
Stroop Test
score of total Stroop test (Stroop Colors and Stroop Words). Word, color, and color-word T-Scores of 40 or less are considered "low." Word, color, and color-word T-Scores above 40 or are considered "normal."
Measured: 30 days
Movement Disorder Society - Unified Parkinson's Disease Rating Scale PART II Score Compare insights MDS-Unified Parkinson's Disease Rating Scale part II (UPDRS-II)
Score of part II of UPDRS, Motor experiences of daily living: 13 items. Score range: 0-52,[8] 12 and below is mild, 30 and above is severe
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start2 Aug 2023
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- This study is a randomized, double-blind, group controlled clinical trial. Parallel study,
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Andrade, Federal University of Paraíba
- Investigators
- Suellen Andrade, Doctor, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145776
- Sponsor's protocol ID
- EEG_DPcog
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2023
- Last updated
- 1 Dec 2023
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive-motor Dual-Task Training and tDCS on Brain Electrical Activity Assessed by EEG and Cognitive Performance in Patients With Parkinson's Disease: a Randomized, Double-blind, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06145776
- Acronym / sponsor ID
- EEG_DPcog
- Keywords
- Parkinson; EEG; cognition; dual-task cost
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 24 Nov 2023 (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.
This study is a group controlled clinical trial. Parallel study, patients aged 40-80 years, with Parkinson disease. Twelve sessions, three times a week, for 30 minutes. Training will consist of Transcranial Direct Current Stimulation linked to tredmill training, in 3 blocks of 7 minutes, and adicionally to the Experimental Group, dual-task cognitive-motor exercises, simultaneously. The investigators will use the folowwing instruments: Auditory Stroop Test, Trail Making Test, Montreal Cognitive Assessment, Timed-up-and-go ST and DT, UPDRS II and III and Eletroencefalography (EEG). The objective is to examine cognitive alterations on PD pacients due to intervention and the relationships between baseline outcomes in responders and non-responders to therapy.
Detailed description
Background: Parkinson disease (PD) is one of the most common age-related brain disorders. PD is defined primarily as a movement disorder, with the typical symptoms being resting tremor, rigidity, bradykinesia and postural instability. In addition to the defining dopamine-related motor symptoms, however, PD is increasingly recognized as a heterogeneous multisystem disorder involving other neurotransmitter systems, such as the serotonergic, noradrenergic and cholinergic circuits. Thus, a wide variety of nonmotor symptoms (NMS) linked with these neurotransmitters are commonly observed in patients with PD. Cognitive decline is among the most common and important NMS. Robust evidence indicates that in comparison with age-matched groups without PD, people with PD exhibit more rapid decline in a number of cognitive domains - in particular, executive, attentional and visuospatial domains, but also memory. In recent years, research has focused on the pre-dementia stages of cognitive impairment in PD, including mild cognitive impairment (MCI). Several longitudinal studies have shown that MCI is a harbinger of dementia in PD, although the course is variable, and stabilization of cognition - or even reversal to normal cognition - is not uncommon. A variety of biomarkers have been studied, some using novel structural and functional imaging techniques, and have documented in vivo brain changes associated with cognitive impairment. 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 the effects of a intervention protocol on brain eletric activity and cognitive outcomes on PD patientes 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 motor-cognitive training in patients with Parkinson's disease. The study will also highlight whether, by qEEG analysis, the clinical factors and variability between individuals that could interfere in the efficacy intervention and influence the therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized, double-blind, group controlled clinical trial. Parallel study,
| Arm | Type | Receives |
|---|---|---|
| dual-task group | Experimental | Other: tDCS + tredmill training (Standart trehab training), Other: Cognitite-motor Dual Task Training (DT training)Dual-Task Training Protocol (DTTP) The dual-task training protocol (DT) will consist in cognitive exercise categories: verbal fluency, mental screening tasks, discrimination, decision-making and reaction time tasks, which will be associated to treadmill gait training (Sousa et al., 2016). Verbal commands will focus on the following: (1) large strides; (2) heel strike; (3) raising the knees while walking (Kelly et al., 2012). |
| control group | Active comparator | Other: tDCS + tredmill training (Standart trehab training)The participants will perform 21 min treadmill gait training associated to tDCS active in F3 for 20 min, 3 times a week for 4 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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. (1992)
- 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 (Hoehn and Yahr, 1998);
- undergoing regular pharmacological treatment with levodopa (equivalent dose > 300 mg) or taking antiparkinsonian medication, such as anticholinergics, selegiline, dopamine agonists, and COMT (catechol-O-methyl transferase) inhibitors for at least 4 weeks prior intervention;
- score of more than 24 points on the Mini-Mental State Examination (Folstein et al., 1975);
Key exclusion criteria (13 listed)
- diagnosis of atypical Parkinson's disease;
- neuropsychiatric comorbidities;
- convulsions, metal clips and/or pacemaker;
- deep brain stimulation implant;
- history of epilepsy; neurosurgery;
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 |
|---|---|---|
| tDCS + tredmill training (Standart trehab training)Standart Rehab training will consist in 20 min treadmill gait training associated to active atDCS F3 2mA for 20 min. | Other | control group, dual-task group |
| Cognitite-motor Dual Task Training (DT training)The dual-task training protocol (DT) will consist in cognitive exercises (verbal fluency, mental screening tasks, discrimination, decision-making and reaction time tasks) and motor exercises (walking while carrying a tray with only one empty glasscarrying a glass while walks, change peaces from one pocket to another, looking from one side to another while walking) | Other | dual-task group |
Primary outcome
EEG outcomes
Time frame: 30 days
PSD of theta, alpha and beta and alpha/theta ratio and beta/theta ratio of 6 ROIs (righ and left: frontal, temporoparietal and occipital)
clinic outcome
Time frame: 30 days
Dual-task cost
5 secondary outcomes
Total Montreal Cognitive Assessment (MoCA)
Time frame: 30 days
domains of MoCA
Time frame: 30 days
Trail Making Test part B (TMT-B)
Time frame: 30 days
Stroop Test
Time frame: 30 days
Movement Disorder Society - Unified Parkinson's Disease Rating Scale PART II Score Compare insights MDS-Unified Parkinson's Disease Rating Scale part II (UPDRS-II)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 34276344Costa-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.
- Individual participant dataSharing planned: No
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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, Doctor principal investigator
Federal University of Paraiba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS + tredmill training (Standart trehab training) and Cognitite-motor Dual Task Training (DT training) in people with Parkinson Disease and Cognition Disorder, run by Federal University of Paraíba at 2 sites 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 7 inclusion and 13 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 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 M Andrade, Doctor (83993812744 ext. +55, suellen.andrade@academico.ufpb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG outcomes (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT06145776, 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 1 Dec 2023.