Implication of Cognitive Reserve in Non-pharmacological Intervention Outcomes

NCT06563453 | Unknown FDA Device

• 1 other identifier: NU21-04-00652
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive reserve (CR) is defined as the gradual accumulation of neural resources and their adaptability (i.e., efficiency, capacity, flexibility) due to genetic and/or lifelong environmental factors that mitigate the cognitive effects of age-related processes and brain diseases. Transcranial alternating current stimulation (tACS) can be used to entrain underlying neuronal networks, promoting firing at specific frequencies. Recent studies have demonstrated that fronto-parietal theta oscillatory activity entrainment via tACS leads to working memory enhancement in healthy subjects. However, there remains significant variability in stimulation-induced aftereffects across individuals. Emerging literature suggests that individual differences, such as CR levels, may be crucial in predicting the benefits of treatment interventions, as they reflect available neural capacity and flexibility. A novel interventional approach is proposed to study CR, utilizing both conventional static proxies, such as premorbid intellect and educational attainment, and dynamic markers, including pupillometry, resting-state, and task-induced functional MRI. By employing cutting-edge noninvasive brain stimulation (NIBS) techniques, the study will acutely modulate network properties to examine the influence of CR on immediate cognitive and brain functional aftereffects induced by the intervention. In addition to focusing on cognitively healthy older adults, this study will, for the first time, include patients with mild cognitive impairment with Lewy bodies (MCI-LB), a prodromal stage of the second most common degenerative dementia after Alzheimer's disease.

Conditions

Aging; Mild Cognitive Impairment; Dementia With Lewy Bodies

Outcome Measures

Primary Outcomes (2)

• Accuracy and reaction times of the visual N-back task in tACS conditions:tACS conditions

  'Online' working memory (WM) task accuracy and reaction times (RT) in both active and sham tACS conditions. tACS conditions

  3.5 years

• Accuracy and reaction times of the verbal N-back task in tACS conditions: tACS conditions

  'Offline' WM task accuracy and reaction times (RT) in both active and sham tACS conditions. tACS conditions

  3.5 years

Secondary Outcomes (3)

• Cognitive reserve moderator:

  3.5 years

• tACS-induced functional connectivity changes:

  3.5 years

• Pupillary changes

  3.5

Study Arms (3)

sham stimulation

SHAM COMPARATOR

Two inactive electrodes (anodes and cathodes) - placed over Medial frontal lobe and Inferior parietal lobe. The flow of current discontinues after 20 seconds, the stimulation continues.

Device: transcranial alternating current stimulation

frontal stimulation

EXPERIMENTAL

One active electrode (anode and cathode) - placed over Medial frontal lobe, one inactive electrode (anode and cathode) - placed over Inferior parietal lobe. Current intensity - 2 (milliamperes) mA, frequency: theta 4.51 Hz, stimulation time: 20 minutes

Device: transcranial alternating current stimulation

frontoparietal stimulation

EXPERIMENTAL

One active electrode (anode and cathode) - placed over Medial frontal lobe, another active electrode (anode and cathode) - placed over Inferior parietal lobe. Current intensity - 2 mA, frequency: theta 4.51 Hz in-phase, stimulation time: 20 minutes

Device: transcranial alternating current stimulation

Interventions

transcranial alternating current stimulation DEVICE

Transcranial Alternating Current Stimulation (tACS) is a tool that administers a weak alternating current (in the range of 0.1 to 4 mA), most often with a sinusoidal waveform, between electrodes placed over target areas. This can entrain the subjacent neuronal networks favouring the firing at specific frequencies of interest, in certain cases, with effects outlasting the stimulation duration up to 70 min.

frontal stimulation; frontoparietal stimulation; sham stimulation

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intact cognitive performance as assessed by cognitive evaluation.
• Subjects with possible or probable mild cognitive impairment with Lewy bodies (MCI-LB).

You may not qualify if:

• Presence of dementia as assessed by a cognitive test battery and evaluation of daily activities.
• Any major psychiatric disorder. History of neurological disease affecting the central nervous system (e.g., tumor, epilepsy, stroke, etc.).
• Severe or repeated head injury. Non-compensated internal or oncological disease. MRI-incompatible metal in the body (e.g., pacemaker). Left-handedness.

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (1)

CEITEC Masaryk University

Brno, 62500, Czechia

RECRUITING

Related Publications (1)

• Mitterova K, Pupikova M, Gajdos M, Eliasova I, Rektorova I. Optimizing tACS for working memory: differential outcomes in healthy aging and non-amnestic mild cognitive impairment. Alzheimers Res Ther. 2025 Dec 2;18(1):2. doi: 10.1186/s13195-025-01922-4.

  PMID: 41331881 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Lewy Body Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ilona Eliášová, Ph.D.

  Masaryk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Mitterova, Ph.D.

CONTACT

735512163; kristina.mitterova@ceitec.muni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 20, 2024
• Study Start: May 1, 2021
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 28, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)