Effects of Transcranial Direct Current Stimulation Associated With Cognitive Training in Alzheimer's Disease

NCT04220593 | Unknown

• 1 other identifier: CogAD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease (AD) is characterized by a progressive decline in cognitive functions, interfering with autonomy and independence. According to the Diagnostic and Statistical Manual of Mental Disorders (DSM 5), mnemonic dysfunction in AD must be related to aphasia, apraxia, agnosia, or changes in executive function. The clinical picture of the disease can be described as mild, moderate and severe. In the mild phase, the patient is disoriented and with difficulties in thinking, in later stages memory lapses become more intense and frequent. The symptoms of apraxia, aphasia and agnosia appear, causing a noticeable impact on the performance of simple daily activities, and neuropsychiatric and behavioral symptoms are expressed. Existing pharmacological treatments for AD treatment are able to minimize the symptoms of the disease, but are not able to promote cure. Therefore, studies have sought to better understand non-pharmacological strategies, aiming at optimizing the benefits of using the drug. Studies have suggested that tDCS promotes significant effects on cognitive processes assessed through cognitive tasks, not only in healthy individuals but also in clinical populations. Cognitive training (TCog) has similarly shown excellent results in the treatment of cognitive deficits due to AD. Thus, the present study aims to investigate when (before, during or after) the tDCS should be applied to potentiate the effects of TCog in people with AD by comparing four protocols of application of neurostimulation associated with TCog.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Change in global cognitive function by the Alzheimer's Disease Assessment Scale (ADAS-Cog)

  Cognitive Scale of the Alzheimer's Disease Assessment Scale (ADAS-Cog), consisting of 11 items that assesses performance related to memory, language, praxis and comprehension skills, with a maximum score of 70 points. Thus, the higher the score, the more compromised the individual is. Application takes about 30 minutes (Mohs \& Cohen, 1988). In addition, the Montreal Cognitive Assessment (MoCA), a cognitive screening tool created by Nasreddine et al. (2005).

  baseline, after 4 weeks and after 12 weeks

• Change in global cognitive function by the Montreal Cognitive Assessment (MoCA)

  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 4 weeks and after 12 weeks

Secondary Outcomes (5)

• Change in Executive Function by the Trail Making Test (TMT)

  baseline, after 4 weeks and after 12 weeks

• Change in Executive Function by the Tower of London

  baseline, after 4 weeks and after 12 weeks

• Change in Functionality by the Disability Assessment for Dementia (DAD)

  baseline, after 4 weeks and after 12 weeks

• Change in Neuropsychiatric symptoms by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

  baseline, after 4 weeks and after 12 weeks

• Change in Occupational performance by theCanadian Occupational Performance Measure (COPM)

  baseline, after 4 weeks and after 12 weeks

Study Arms (4)

aETCC before TCog

EXPERIMENTAL

Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.

Other: tDCS associated with Tcog

aETCC during TCog

EXPERIMENTAL

Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.

Other: tDCS associated with Tcog

aETCC after TCog

EXPERIMENTAL

Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.

Other: tDCS associated with Tcog

Simulated aETCC during TCog

SHAM COMPARATOR

Anodic transcranial direct current stimulation (tDCS) over left dorsolateral prefrontal cortex (DLPFC) associated with cognitive training (Tcog). Duration: 20 minutes; Intensity: 2mA.

Other: tDCS associated with Tcog

Interventions

tDCS associated with Tcog OTHER

2mA-intensity aETCC will be applied to the left dorsolateral prefrontal cortex (CPFDL) region for 20 min, three times a week (every other day) over a one-month period, totaling 12 sessions. In each session activities aimed at stimulating cognition will be applied over the 20 minutes.

Simulated aETCC during TCog; aETCC after TCog; aETCC before TCog; aETCC during TCog

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be included in this study following the following requirements: (a) age between 55 and 85 years; (b) probable diagnosis AD; (c) scores higher than 18 on the Mini Mental State Examination (MMSE); (e) did not receive regular cognitive intervention within 3 months prior to the start of this clinical trial.

You may not qualify if:

• Patients will be excluded from this study while not meeting the following criteria: (a) individuals with severe metabolic and / or cardiac disorders, alcoholism, focal neurological disorders and associated psychiatric disorders; (b) use of hypnotics and benzodiazepines two weeks prior to study initiation; or (c) use of medication with cholinergic inhibitors and memantine for more than two months prior to this clinical trial; (d) or with any condition that could impair the neuropsychological assessment process or receive a cognitive intervention protocol from the study will be excluded from the study. In addition, participants with transient or definitive pacemakers, cochlear implants, or intracranial aneurysm clips will be excluded; (e) individuals with a history of seizures; (f) the presence of tumors, epilepsy or substance abuse.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Suellen Andrade

João Pessoa, Paraíba, Brazil

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Suellen Andrade

  Universidade Federal da Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suellen Andrade

CONTACT

+55 83 999371471; suellenandrade@gmail.com

Gabriella Conserva

CONTACT

+55 83 98747-1386; gabriellac.to@gmail.com

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 teacher

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: January 7, 2020
• Study Start: November 25, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

BR (1)