Multifocal Neuromodulation in Motor and Cognitive Function of People With Parkinson's Disease
1 other identifier
interventional
45
1 country
1
Brief Summary
People with Parkinson's disease (PD) experience various motor and nonmotor symptoms throughout its evolution. It is characterized mainly by the presence of tremor, stiffness, bradykinesia and postural instability, leading to progressive functional limitation and impairment in the performance of usual activities of daily living. In addition, patients may have cognitive disorders, memory deficits, problems related to visuospatial dysfunction, difficulties in performing sequential or repetitive movements, freezing, and slow psychological responses. Previous studies analyzed by systematic reviews suggest the efficacy of Transcranial Direct Current Stimulation (tDCS) to improve the motor and non-motor symptoms of PD, depending on the area of stimulation. However, most of these focus only on one specific area. Therefore, the overall objective of this study is to investigate the effects of multifocal neuromodulation on the motor and cognitive function of people with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2019
CompletedFirst Posted
Study publicly available on registry
September 16, 2019
CompletedStudy Start
First participant enrolled
January 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFebruary 17, 2021
February 1, 2021
1.4 years
September 12, 2019
February 13, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 6 weeks, and after 10 weeks (follow-up)
Changes in cognitive function assessed by the 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 6 weeks, and after 10 weeks (follow-up)
Secondary Outcomes (6)
Changes in attention and mental flexibility assessed by the Trail Making Test - A and B
Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in executive functions and planning assessed by the London Tower Task
Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in working memory assessed by the Digit Span Forward and Backward Test
Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in balance assessed by the Mini-BESTest
Baseline, after 6 weeks, and after 10 weeks (follow-up)
Changes in gait speed assessed by 10 Meter Walk Test
Baseline, after 6 weeks, and after 10 weeks (follow-up)
- +1 more secondary outcomes
Study Arms (3)
tDCS over M1 and DLPFC
EXPERIMENTALAnodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC). Duration: 20 minutes; Intensity: 2mA.
tDCS over M1 and FPA
EXPERIMENTALAnodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1) and left frontal polar area (FPA). Duration: 20 minutes; Intensity: 2mA.
tDCS over M1
ACTIVE COMPARATORAnodic transcranial direct current stimulation (tDCS) over left primary motor cortex (M1). Duration: 20 minutes; Intensity: 2mA.
Interventions
Participants will receive 15 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, 5 times a week. The current will be delivered via saline-embedded sponge surface electrodes using a battery-powered neurostimulator (TCT-Research, Trans Cranial Technologies, Hong Kong). A small active specific electrode (5x5 cm) will be used to prevent coverage of adjacent areas, resulting in a current density of 0.08 mA / cm². These parameters are within the safe limits established in previous human studies.
Eligibility Criteria
You may qualify if:
- Diagnosis of idiopathic PD, issued by a neurologist specializing in movement disorders;
- Disease staging between I and III, according to the modified Hoehn and Yahr scale;
- Be using antiparkinsonian medication regularly;
- Score higher than 24 or 18 (for participants with low education), verified through the Mini Mental State Examination.
You may not qualify if:
- Diagnosis of atypical parkinsonism;
- Neurological comorbidities;
- History of epilepsy, neurosurgery (including metal clip implantation) and pacemaker implantation;
- Previous surgical intervention for PD (DBS implantation - deep brain stimulation);
- Presence of severe freezing episodes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Suellen Marinho Andrade
João Pessoa, Paraíba, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suellen Andrade
Federal University of Paraiba
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator and Professor
Study Record Dates
First Submitted
September 12, 2019
First Posted
September 16, 2019
Study Start
January 30, 2020
Primary Completion
July 1, 2021
Study Completion
September 1, 2021
Last Updated
February 17, 2021
Record last verified: 2021-02