Using EEG to Identify Cognitive Changes in Parkinson's Disease

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 testing if combining brain stimulation with treadmill training can improve thinking skills in people with Parkinson's Disease aged 40-70.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Federal University of Paraíba (Academic / other)
• Locations: 2 sites (João Pessoa, Paraiba and 1 other locations)
• Trial ID: NCT06145776 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Transcranial Direct Current Stimulation (tDCS) combined with treadmill training on cognitive function in patients with Parkinson's Disease. Participants aged 40-70 will undergo twelve sessions of training, which includes dual-task cognitive-motor exercises. The study aims to assess cognitive alterations through various tests, including the Auditory Stroop Test and Montreal Cognitive Assessment, while also utilizing Electroencephalography (EEG) to monitor brain activity. The goal is to understand the relationship between cognitive responses to the intervention and baseline characteristics of the patients.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-70 diagnosed with idiopathic Parkinson's Disease who are responsive to levodopa treatment.

Not a fit: Patients with advanced Parkinson's Disease beyond stage 3 or those with significant cognitive impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cognitive function and quality of life for patients with Parkinson's Disease.

How similar studies have performed: Other studies have shown promise in using cognitive-motor training and tDCS for cognitive improvement in Parkinson's Disease, indicating a potential for success in this approach.

Eligibility criteria

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. (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.

Exclusion Criteria:

* 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.

Where this trial is running

João Pessoa, Paraiba and 1 other locations

• Federal University of Paraiba — João Pessoa, Paraiba, Brazil (Recruiting)
• Aging and Neuroscience Studies Laboratory — João Pessoa, Brazil (Recruiting)

Study contacts

• Principal investigator: Suellen Andrade, Doctor — Federal University of Paraiba
• Study coordinator: Suellen M Andrade, Doctor

Conditions Parkinson Disease; Cognition Disorder; EEG With Abnormally Slow Frequencies; Parkinson; EEG; cognition; dual-task cost