Parkinson Disease Clinical Trial
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.
NCT number | NCT06145776 |
Other study ID # | EEG_DPcog |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2, 2023 |
Est. completion date | April 2024 |
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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | April 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Aging and Neuroscience Studies Laboratory | João Pessoa | |
Brazil | Federal University of Paraiba | João Pessoa | Paraiba |
Lead Sponsor | Collaborator |
---|---|
Federal University of Paraíba |
Brazil,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | clinic outcome | Dual-task cost | 30 days | |
Secondary | 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. | 30 days | |
Secondary | 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). | 30 days | |
Secondary | Trail Making Test part B (TMT-B) | TMT-B is scored based on how long it takes to complete the test, within 5 minutes. | 30 days | |
Secondary | 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." | 30 days | |
Secondary | 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 | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05415774 -
Combined Deep Brain Stimulation in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04691661 -
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
|
Phase 2 | |
Active, not recruiting |
NCT05754086 -
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
|
||
Completed |
NCT04045925 -
Feasibility Study of the Taïso Practice in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04194762 -
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
|
N/A | |
Completed |
NCT02705755 -
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05830253 -
Free-living Monitoring of Parkinson's Disease Using Smart Objects
|
||
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Recruiting |
NCT06139965 -
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
|
||
Completed |
NCT04580849 -
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
|
N/A | |
Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
Completed |
NCT03980418 -
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
|
N/A | |
Completed |
NCT04942392 -
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
|
N/A | |
Terminated |
NCT03446833 -
LFP Beta aDBS Feasibility Study
|
N/A | |
Completed |
NCT03497884 -
Individualized Precise Localization of rTMS on Primary Motor Area
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT04997642 -
Parkinson's Disease and Movement Disorders Clinical Database
|
||
Completed |
NCT04117737 -
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
|
N/A | |
Recruiting |
NCT03618901 -
Rock Steady Boxing vs. Sensory Attention Focused Exercise
|
N/A |