NCT04581590Active, not recruiting
The Impact TDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease
Can Task Specificity and Baseline Outcomes Impact TDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease? a Protocol for a Controlled, Double-blind, Randomized Multicentric Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 Jan 2025
Brief summary (registry, in English)
This study is a group controlled clinical trial. Parallel study, patients aged 40-70 years, with Parkinson disease. Twelve sessions, three times a week, for 30 minutes, simultaneously to the rehabilitation program. Training will consist of Transcranial Direct Current Stimulation linked dual-task exercises or dual-taks exercises with cognitive training, applied three times a week during four weeks. The investigators will used instruments: dual-task gait speed (Auditory Stroop Task ), executive function (Wisconsin Card Sorting Test , Auditory Stroop Test, Trail Making Test, Verbal Fluency Test and Montreal Cognitive Assessment), and, the objective is to examine task-dependency in enhancing the effects of tDCS-linked rehabilitation training on PD and the relationships between baseline outcomes in responders and non-responders to therapy.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 242 (estimated)
- First submitted
- 31 Aug 2020
- Start date
- 3 Oct 2022
- Primary completion date
- 15 Jul 2024
- Lead sponsor
- Federal University of Paraíba
- Diseases
- Parkinson disease
- NCT number
- NCT04581590
What you commit to
- Study type: Interventional
- Planned participants: 242
- From 3 Oct 2022 to the primary completion date, 15 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- undergoing physical therapy at another location
- chemical scalp treatment within the previous 30 days, and experiencing severe pain and/or discomfort that precludes performing the proposed activities.
Other illness
- be 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
Other
- 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 3 measurements taken 5 minutes apart - Cut-off: systolic blood pressure ≥ 140 mm Hg and/or diastolic ≥ 90 mm Hg
- not understanding any of the training protocol stages
Who the study is looking for
- 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.
- 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
- undergoing regular pharmacological treatment with levodopa (equivalent dose \> 300mg) or taking antiparkinsonian medication such as anticholinergics, selegiline, dopamine agonists (amantadine) and COMT (catechol-O-methyl transferase) inhibitors
- score of more than 24 points on the Mini-Mental State Examination
- not exhibiting other associated neurological diseases and no musculoskeletal and/or cardiorespiratory changes that could compromise gait.
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal University of Paraíba Coordinator of this site? Confirm its status | João Pessoa | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.