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

NCT04581590 | Active Not Recruiting

• 1 other identifier: tDCSparkinson
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Cognition Disorder; Motor Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Changes in executive functions assessed by Wisconsin Card Sorting Test (WCST)

  [Baseline, after 04 weeks]

• Changes in executive functions assessed by Trail Making Test (TMT)

  [Baseline, after 04 weeks]

• Changes in executive functions assessed by Verbal Fluency Test

  [Baseline, after 04 weeks]

• Changes in executive functions assessed by Montreal Cognitive Assessment (MoCA)

  [Baseline, after 04 weeks]

• Changes in motor functions assessed by Dynamic Gait Index (DGI)

  [Baseline, after 04 weeks]

Study Arms (2)

Active group

ACTIVE COMPARATOR

In the group G1 will be administered: tDCS active + dual-task motor training + cognitive training.

Other: Cognitive training

Sham group

SHAM COMPARATOR

In the group G2 will be administered: tDCS active + dual-task motor training

Other: Cognitive training

Interventions

Cognitive training OTHER

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.

Also known as: tDCS active

Active group; Sham group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead
• Universidade Federal do Rio Grande do Norte: collaborator

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, 58051-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 34276344 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Cognition Disorders; Motor Disorders

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Suellen Suellen Andrade

  Federal University of Paraíba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Professor

Model Details: 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

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: October 9, 2020
• Study Start: October 3, 2022
• Primary Completion: July 15, 2024
• Study Completion: February 2, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)