Back to resultsThe Impact tDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease
Primary Purpose
Parkinson Disease, Cognition Disorder, Motor Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive training
Sponsored by
About this trial
This is an interventional prevention trial for Parkinson Disease
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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active group
Sham group
Arm Description
In the group G1 will be administered: tDCS active + dual-task motor training + cognitive training.
In the group G2 will be administered: tDCS active + dual-task motor training
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
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.
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).
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
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.
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);
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.
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
Full Information
NCT ID
NCT04581590
First Posted
August 31, 2020
Last Updated
October 5, 2020
Sponsor
Federal University of Paraíba
Collaborators
Universidade Federal do Rio Grande do Norte
1. Study Identification
Unique Protocol Identification Number
NCT04581590
Brief Title
The Impact tDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
Collaborators
Universidade Federal do Rio Grande do Norte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Cognition Disorder, Motor Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a sham-controlled, double-blind randomized multicentric clinical trial will analyze patients with a confirmed diagnosis of Parkinson disease who were subjected to tDCS associated with dual-task motor training and cognitive tranining
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
242 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active group
Arm Type
Active Comparator
Arm Description
In the group G1 will be administered: tDCS active + dual-task motor training + cognitive training.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
In the group G2 will be administered: tDCS active + dual-task motor training
Intervention Type
Other
Intervention Name(s)
Cognitive training
Other Intervention Name(s)
tDCS active
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes dual-task gait speed by the Auditory Stroop Task
Description
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.
Time Frame
[Baseline, after 04 weeks]
Secondary Outcome Measure Information:
Title
Changes in executive functions assessed by Wisconsin Card Sorting Test (WCST)
Description
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.
Time Frame
[Baseline, after 04 weeks]
Title
Changes in executive functions assessed by Trail Making Test (TMT)
Description
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
Time Frame
[Baseline, after 04 weeks]
Title
Changes in executive functions assessed by Verbal Fluency Test
Description
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
Time Frame
[Baseline, after 04 weeks]
Title
Changes in executive functions assessed by Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
[Baseline, after 04 weeks]
Title
Changes in motor functions assessed by Dynamic Gait Index (DGI)
Description
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).
Time Frame
[Baseline, after 04 weeks]
Title
Changes in motor functions assessed by 10-meter walk test
Description
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
Time Frame
[Baseline, after 04 weeks]
Title
Changes in motor functions assessed by Timed Up and Go (TUG) test
Description
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.
Time Frame
[Baseline, after 04 weeks]
Title
Changes in motor functions assessed by Kinematics of Gait
Description
To analyze movement using the Qualisys Motion Capture System (Qualisys Medical AB, 411 13, Gothenburg, Sweden);
Time Frame
[Baseline, after 04 weeks]
Title
Changes in motor function assessed by the Unified Parkinson's Disease Rating Scale - Part III (UPDRS - III)
Description
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.
Time Frame
[Baseline, after 04 weeks]
Title
Changes in motor function assessed by Activities-specific balance confidence (ABC) scale
Description
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
Time Frame
[Baseline, after 04 weeks]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suellen Suellen Andrade
Phone
986046032
Ext
55 83
Email
suellenandrade@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suellen Suellen Andrade
Organizational Affiliation
Federal University of Paraíba
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34276344
Citation
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.
Results Reference
derived
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The Impact tDCS-linked Motor and Cognitive Training Gains in Parkinson's Disease
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