Cognitive DysfunctionNCT06733714
Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults
A study testing Transcranial Alternating Current Stimulation and Digital Cognitive Training in people with Cognitive Dysfunction and Alzheimer Disease, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Transcranial Alternating Current Stimulation and Digital Cognitive Training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Dec 2024to 1 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects over 50 years old, with cognitive complaints
Who cannot join
- 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
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- Use of anticoagulants
- Intracranial metallic prosthesis or cardiac pacemaker
- Any contraindication to performing tACS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Clínica da Memória - IPUB / UFRJ
Rio de Janeiro, Rio de Janeiro, 22290140
Brunno Costa, PhD student, +5521997790223, fc_brunno@hotmail.com
About this study
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.
Read the detailed description
Our goals in this study are:
- To investigate the feasibility and safety of transcranial direct current stimulation (tDCS) adjunctive to cognitive training (CT) in a cohort of individuals diagnosed with mild cognitive impairment (MCI), Subjective Cognitive Decline or Alzheimer's desease in it's initial phase (CDR 1).
- To assess the efficacy of this combined intervention in modulating cognitive function, as measured by a comprehensive neuropsychological battery.
- To explore the underlying neural mechanisms of this intervention by examining changes in event-related potentials (ERPs), specifically the N200 and P300 components, which are sensitive to cognitive processes and neural plasticity.
- To identify potential peripheral biomarkers in serum that may correlate with cognitive decline and response to the intervention.
- To determine whether the combined intervention can induce lasting changes in neurophysiological markers, as assessed by repeated ERP measurements.
- To examine the relationship between the observed cognitive improvements, alterations in neurophysiological measures, and changes in serum biomarker levels, with the aim of elucidating the biological mechanisms underlying the intervention's effects.
- Conditions
- Cognitive Dysfunction, Alzheimer Disease, Mild Cognitive Impairment, Cognitive Decline, Frontotemporal Degeneration, Dementia
- Being tested
- Transcranial Alternating Current Stimulation, Digital Cognitive Training
- Keywords
- tacs, nibs, transcranial alternate current stimulation, mild cognitive impairment, MCI, ALzheimer, Cognition, Elderly, Older Adults, Cognitive enhancement
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Dementia, Vascular, Lewy Body Disease, Plaque, Amyloid, Frontotemporal Dementia, Spondylocostal Dysostosis 4, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current StimulationDevice
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.
Digital Cognitive TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcranial Alternating Current Stimulation; Device: Digital Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after intervention
Secondary outcomes (11)
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.
Measured: 1 week after intervention
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start2 Dec 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Rogerio Panizzutti, MD, PhD, Universidade Federal do Rio de Janeiro
- Investigators
- Rogerio Panizzutti, Professor, Principal investigator, UFRJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733714
- Sponsor's protocol ID
- 38114820.3.0000.5263
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All study outcomes, including primary and secondary endpoints, will be made available upon request.