The Role of EEG in Identifying Cognitive Changes in Parkinson's Disease

NCT06145776 | Unknown

• 1 other identifier: EEG_DPcog
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Parkinson Disease; Cognition Disorder; EEG With Abnormally Slow Frequencies

Keywords

Parkinson; EEG; cognition; dual-task cost

Outcome Measures

Primary Outcomes (2)

• 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)

  30 days

• clinic outcome

  Dual-task cost

  30 days

Secondary Outcomes (5)

• Total Montreal Cognitive Assessment (MoCA)

  30 days

• domains of MoCA

  30 days

• Trail Making Test part B (TMT-B)

  30 days

• Stroop Test

  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)

  30 days

Study Arms (2)

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).

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.

Other: tDCS + tredmill training (Standart trehab training)

Interventions

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.

control group; dual-task group

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)

dual-task group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (2)

Federal University of Paraiba

João Pessoa, Paraíba, 51051900, Brazil

RECRUITING

Aging and Neuroscience Studies Laboratory

João Pessoa, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 34276344 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Cognition Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Suellen Andrade, Doctor

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suellen M Andrade, Doctor

CONTACT

83993812744; suellen.andrade@academico.ufpb.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly allocated, using an online generator (www.random.org), into two groups (1:1): CG) tDCS active + gait training; EG) tDCS active + gait training + dual-task. This sequence will be performed independently and remotely by a blinded investigator, who will have no knowledge of other study procedures. The concealed allocation process will be conducted using sequentially numbered sealed opaque envelopes. The outcome assessors and patients will be blinded to the procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Suellen Marinho Andrade, Federal University of Paraíba

Model Details: This study is a randomized, double-blind, group controlled clinical trial. Parallel study,

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: August 2, 2023
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)