Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults

NCT06733714 | Recruiting

• 1 other identifier: 38114820.3.0000.5263
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND Cognitive decline in older adults, especially those who develop Mild Cognitive Impairment and Alzheimer's Disease, currently has limited options of pharmacological treatments, with modest efficacy. Digital Cognitive Training (DCT) and Transcranial Alternating Current Stimulation (tACS) are two promising tools for cognitive remediation in this population. In this exploratory study, we investigate feasibility, tolerability and preliminary effects of the association of both interventions in older adults with cognitive complaints. METHODS Older adults with cognitive complaints are being enrolled for this study, which comprises 5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving theta tACS (6Hz, 1.6mA) targeting the Left Dorsolateral Prefrontal Cortex.

Conditions

Cognitive Dysfunction; Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline; Frontotemporal Degeneration; Dementia; Dementia, Vascular; Lewy Body Disease; Beta-Amyloid; GFAP; Tau Protein

Keywords

tacs; nibs; transcranial alternate current stimulation; mild cognitive impairment; MCI; ALzheimer; Cognition; Elderly; Older Adults; Cognitive enhancement

Outcome Measures

Primary Outcomes (1)

• MONTREAL COGNITIVE ASSESSMENT (MOCA)

  The MoCA, or Montreal Cognitive Assessment, is a screening tool designed to evaluate global cognitive function, covering domains such as memory, executive function, language, visuospatial abilities, and attention. Scores range from 0 to 30, with higher scores indicating better cognitive performance and a score below 26 often considered indicative of cognitive impairment.

  1 week after intervention

Secondary Outcomes (11)

• Five digits test (FDT)

  1 week after intervention

• Rey-Osterrieth complex figure (ROCF)

  1 week after intervention

• Semantic and phonemic verbal fluency

  1 week after intervention

• The Rey Auditory Verbal Learning Test (RAVLT)

  1 week after intervention

• Visual P300 (Event-Related Potential)

  1 week after intervention

Study Arms (2)

tACS+DCT

EXPERIMENTAL

5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving theta tACS (6Hz, 1.6mA) targeting the Left Dorsolateral Prefrontal Cortex.

Device: Transcranial Alternating Current Stimulation; Device: Digital Cognitive Training

SHAM+DCT

SHAM COMPARATOR

5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving stimulation with the device in SHAM mode (with Ramp Up, no current during the session period and Ramp down) targeting the Left Dorsolateral Prefrontal Cortex.

Device: Transcranial Alternating Current Stimulation; Device: Digital Cognitive Training

Interventions

Transcranial Alternating Current Stimulation DEVICE

An alternate eletric current of 1.6mA in theta frequency is applied in the scalp, using two eletrodes (5x5cm). The eletrodes are located aiming for the left dorsolateral prefrontal Cortex area.

SHAM+DCT; tACS+DCT

Digital Cognitive Training DEVICE

Using a tablet, the participant will do exercises that were designed to stimulate cognitive domains, especially attention and memory. In this case, we use the BrainHQ platform.

SHAM+DCT; tACS+DCT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects over 50 years old, with cognitive complaints

You may not qualify if:

• Estimated Intelligence Quotient \<80
• Dependence on psychoactive substances (DSM-V)
• Severe psychiatric or neurological disorders
• Uncorrected visual/hearing problems
• History of syncope for an unexplained reason or seizure less than a year ago
• Previous stroke
• Use of anticoagulants
• Intracranial metallic prosthesis or cardiac pacemaker
• Any contraindication to performing tACS

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Alzheimer's Association: collaborator
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Clínica da Memória - IPUB / UFRJ

Rio de Janeiro, Rio de Janeiro, 22290140, Brazil

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia; Dementia, Vascular; Lewy Body Disease; Plaque, Amyloid; Frontotemporal Dementia; Spondylocostal Dysostosis 4, Autosomal Dominant

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Rogerio Panizzutti, Professor

  UFRJ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogerio Panizzutti, Professor

CONTACT

+55:21-3938-5588; rogerio.panizzutti@ipub.ufrj.br

Brunno Costa, PhD student

CONTACT

+55 31996773008; fc_brunno@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A random 5 digits password will be given to the care provider. This password will make the stimulation device enter SHAM mode or true stimulation mode, without the care provider or the patient knowing which mode it will be in. The SHAM mode has the Ramp up and Ramp down periods, so the participant allocated in the control-SHAM group will feel the effects of the eletric current on the scalp for some seconds in the begining and end of each session. Outcome assessors will also not be informed which group the participant is allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 13, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified individual participant data (IPD) collected during the study will be made available upon reasonable request. Researchers interested in accessing the data may contact the principal investigator by providing a detailed proposal outlining the purpose of the request and intended analyses. Access will be made available upon request for a period of 5 years following the publication of the study's primary results.
• Access Criteria: Data will only be shared for research purposes that align with ethical guidelines and after appropriate data-sharing agreements are established.

Locations

BR (1)