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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
| Rio de Janeiro State Research Supporting Foundation (FAPERJ) | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
Our goals in this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Five digits test (FDT) | The FDT assesses attention, processing speed, and executive function. Participants perform tasks involving numerical stimuli under timed conditions. Performance is evaluated based on accuracy and reaction time, with faster and more accurate responses reflecting better cognitive function. | 1 week after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rogerio Panizzutti, Professor | Contact | +55:21-3938-5588 | rogerio.panizzutti@ipub.ufrj.br | |
| Brunno Costa, PhD student | Contact | +55 31996773008 | fc_brunno@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rogerio Panizzutti, Professor | UFRJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica da Memória - IPUB / UFRJ | Recruiting | Rio de Janeiro | Rio de Janeiro | 22290140 | Brazil |
All study outcomes, including primary and secondary endpoints, will be made available upon request.
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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.
Data will only be shared for research purposes that align with ethical guidelines and after appropriate data-sharing agreements are established.
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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.
| 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. |
|
| Rey-Osterrieth complex figure (ROCF) |
The ROCF evaluates visuospatial constructional abilities, visual memory, and organizational skills. Participants copy a complex figure (copy task) and later reproduce it from memory (recall task). Scores range from 0 to 36, with higher scores representing better performance and lower scores indicating impaired abilities. |
| 1 week after intervention |
| Semantic and phonemic verbal fluency | These tasks measure verbal fluency and executive function by asking participants to generate as many words as possible within a category (semantic fluency) or starting with a specific letter (phonemic fluency) within a limited time. Higher scores indicate better fluency and cognitive flexibility, while lower scores suggest deficits in these areas. | 1 week after intervention |
| The Rey Auditory Verbal Learning Test (RAVLT) | The RAVLT assesses verbal memory, including immediate recall, learning, and delayed recall, as well as susceptibility to interference. Scores vary based on the number of correctly recalled items across trials, with higher scores indicating better memory performance and lower scores reflecting poorer memory function. | 1 week after intervention |
| Visual P300 (Event-Related Potential) | The P300 is an electrophysiological measure of cognitive processing, typically recorded using EEG during an oddball paradigm. It reflects attention and working memory processes, with shorter latencies and higher amplitudes indicating more efficient neural processing and longer latencies or reduced amplitudes suggesting impairment. | 1 week after intervention |
| Serum GFAP Analysis | Glial fibrillary acidic protein (GFAP) is a biomarker of astrocytic activation and neuroinflammation. Higher serum GFAP levels may indicate glial activation or neurodegeneration, while lower levels are associated with normal brain health. | before intervention |
| Serum Beta-Amyloid Analysis | This analysis quantifies beta-amyloid peptides, key biomarkers of Alzheimer's disease pathology. Elevated beta-amyloid levels or an altered ratio of amyloid-beta 42/40 in serum may reflect early neurodegenerative processes, while normal levels are indicative of typical brain function. | before intervention |
| Serum Tau Protein Analysis | Serum tau protein levels reflect axonal injury or neurodegeneration. Elevated tau concentrations may indicate pathological processes such as Alzheimer's disease or other neurodegenerative disorders, while normal levels suggest no significant axonal damage. | before intervention |
| Prosaccade Task (Eye Tracking) | This task evaluates basic saccadic eye movement control. Participants are instructed to fixate on a peripheral target as it appears. Key metrics include reaction time, accuracy, and velocity of saccades, with faster and more accurate responses indicating better ocular motor control. | 1 week after intervention |
| Antisaccade Task (Eye Tracking) | This task assesses inhibitory control and executive function. Participants must suppress a reflexive saccade to a peripheral target and instead look in the opposite direction. Metrics such as error rates, reaction times, and corrected errors are analyzed, with fewer errors and faster reaction times indicating better inhibitory control and executive function. | 1 week after intervention |
| Visual Search Task (Eye Tracking): | This task evaluates visual attention and search efficiency. Participants identify a target among distractors under varying levels of complexity. Performance is measured by reaction time and accuracy, with faster and more precise responses indicating better attentional control and visual search ability. | 1 week after intervention |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D015140 | Dementia, Vascular |
| D020961 | Lewy Body Disease |
| D058225 | Plaque, Amyloid |
| D057180 | Frontotemporal Dementia |
| C565149 | Spondylocostal Dysostosis 4, Autosomal Dominant |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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