The Impact tDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Can Task Specificity and Baseline Outcomes Impact tDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease? A Protocol for a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04581590
• Other study ID #: tDCSparkinson
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: September 2021

Study information

• Verified date: October 2020
• Source: Federal University of Paraíba
• Contact: Suellen Suellen Andrade
• Phone: 986046032
• Email: suellenandrade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background: 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 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.

Discussion: This study will evaluate the effectiveness of an intervention protocol with transcranial direct current stimulation, dual-task training and cognitive training in patients with Parkinson's disease. The study will also highlight whether the clinical factors and variability between individuals that could interfere in the training of a specific task and influence the therapeutic effect.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 242
• Est. completion date: September 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 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.

• 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.

Exclusion Criteria:

• 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

• 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 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

• chemical scalp treatment within the previous 30 days, and experiencing severe pain and/or discomfort that precludes performing the proposed activities.

Related Conditions & MeSH terms

• Cognition Disorder
• Cognition Disorders
• Disease
• Motor Disorders
• Parkinson Disease

Intervention

Other:
• Cognitive training
Both groups will undergo the motor training where only the type of received electric current is varied (active or simulated sham type) associated cognitive training. The twelve sessions will be performed in three sessions per week for 30 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Paraíba	Universidade Federal do Rio Grande do Norte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes dual-task gait speed by the Auditory Stroop Task	For this outcome, the Auditory Stroop Task participants will be asked to walk while listening to words spoken loudly and softly and indicate if the volume heard was loud or low, irrespective of the word pronounced.	[Baseline, after 04 weeks]
Secondary	Changes in executive functions assessed by Wisconsin Card Sorting Test (WCST)	The Wisconsin Card Sorting Test (WCST) is a neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement. A number of stimulus cards are presented to the participant. The participant is told to match the cards, but not how to match; however, they are told whether a particular match is right or wrong. The original WCST used paper cards and was carried out with the experimenter on one side of the desk facing the participant on the other. The test takes approximately 12-20 minutes to carry out and generates a number of psychometric scores, including numbers, percentages, and percentiles of: categories achieved, trials, errors, and perseverative errors.	[Baseline, after 04 weeks]
Secondary	Changes in executive functions assessed by Trail Making Test (TMT)	The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, as well as executive functioning	[Baseline, after 04 weeks]
Secondary	Changes in executive functions assessed by Verbal Fluency Test	The Verbal Fluency Test are a kind of psychological test in which participants have to produce as many words as possible from a category in a given time (usually 60 seconds). This category can be semantic, including objects such as animals or fruits, or phonemic, including words beginning with a specified letter, such as p, for example	[Baseline, after 04 weeks]
Secondary	Changes in executive functions assessed by Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool. MoCA is composed of eight cognitive domains, which are scored within a range of 0 to 30 points (higher scores indicate better function): short-term memory; visuospatial skills; executive function; verbal fluency; attention, concentration and working memory; language; sentence repetition; and spatiotemporal orientation.	[Baseline, after 04 weeks]
Secondary	Changes in motor functions assessed by Dynamic Gait Index (DGI)	The Dynamic Gait Index (DGI) assess gait, balance and fall risk. It evaluates not only usual steady-state walking, but also walking during more challenging tasks. A four-point ordinal scale, ranging from 0-3. "0" indicates the lowest level of function and "3" the highest level of function (total score = 24).	[Baseline, after 04 weeks]
Secondary	Changes in motor functions assessed by 10-meter walk test	The 10-meter walk test to estimate gait speed by recording the average time the patient takes to cover a distance of 10m in three attempts	[Baseline, after 04 weeks]
Secondary	Changes in motor functions assessed by Timed Up and Go (TUG) test	The Timed Up and Go (TUG) test to stand up from a chair at the command, walk 3 meters walk along a demarcated course, turn around and walk back to the chair, then sit down.	[Baseline, after 04 weeks]
Secondary	Changes in motor functions assessed by Kinematics of Gait	To analyze movement using the Qualisys Motion Capture System (Qualisys Medical AB, 411 13, Gothenburg, Sweden);	[Baseline, after 04 weeks]
Secondary	Changes in motor function assessed by the Unified Parkinson's Disease Rating Scale - Part III (UPDRS - III)	For this outcome, the Unified Parkinson's Disease Rating Scale - Part III will be used. Section III provides an overall score for movement-related functions and activities (tremor, stiffness, gait, alternating movements, among others). This section is made up of 33 items, which can range from zero (normal) to four (severe), with responses that are linked to commonly accepted clinical terms. The higher the score, the greater the impairment of motor function.	[Baseline, after 04 weeks]
Secondary	Changes in motor function assessed by Activities-specific balance confidence (ABC) scale	For this outcome, Activities-specific balance confidence (ABC) scale to measure the level of confidence in performing daily activities, in addition to identifying fear of falling and possible social isolation	[Baseline, after 04 weeks]