Evaluation of the Effectiveness and Safety of Transcranial Direct Current Stimulation in Combination With Nasal Near Infrared Stimulation to Improve Cognitive Functions and Quality of Life in Elderly People With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD).

December 4, 2025 updated by: Jakub Kazmierski, Medical University of Lodz

Evaluation of the Effectiveness and Safety of an Innovative, Non-pharmacological Method Using Transcranial Direct Current Stimulation in Combination With Cognitive Training and Nasal Near Infrared Stimulation to Improve Cognitive Functions and Quality of Life in Elderly People With Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD).

Alzheimer's disease (AD) and mild cognitive impairment (MCI) are progressive neurodegenerative conditions with limited therapeutic options. Today, around 30 million people worldwide suffer from Alzheimer's dementia. According to WHO predictions, the number of people affected by Alzheimer's disease in 2030 will amount to 65 million, and in 2050 nearly 115 million This means that the number of people suffering from Alzheimer's disease will triple in the next 30 years. The exact cause of Alzheimer's disease is still unknown. The amyloid hypothesis assumes that the accumulation of insoluble β-amyloid 42 aggregates in the central nervous system (CNS) triggers tau hyperphosphorylation (taupathy) and neurodegeneration in AD from the preclinical stage to dementia. In the 1990s, pharmacological treatment of Alzheimer's disease was introduced, but numerous studies indicate its limited effectiveness. Despite many attempts, there is currently no effective drug to delay the course of Alzheimer's disease. In recent years, there have been scientific reports indicating that the use of neuromodulatory therapies has a positive effect on the cognitive functions, behavior and daily functioning of AD patients.

Neuromodulation techniques such as transcranial direct current stimulation (tDCS) and photobiomodulation (PBM) have shown promise in improving cognitive function, but their combined effects remain underexplored.

The aim of the current project is to develop an effective and safe therapeutic procedure based on transcranial direct current stimulation (tDCS) therapy enriched with near infrared nasal stimulation (iNIRS) in patients diagnosed with mild cognitive impairment (MCI) and Alzheimer's disease (AD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the current project is to develop an effective and safe therapeutic procedure based on transcranial direct current stimulation (tDCS) therapy enriched with cognitive training and near infrared nasal stimulation (iNIRS) in patients diagnosed with mild cognitive impairment (MCI) and Alzheimer's disease (AD) . The project will also evaluate the effectiveness of the selected therapeutic method and its impact on the improvement of cognitive functions of patients, including memory, attention, concentration, executive and language functions, as well as the presence of neuropsychiatric symptoms / behavioral disorders in patients and the quality of life of patients.

People meeting the inclusion criteria will be invited to participate in the study and will be provided with and written information about the research project and a voluntary, informed consent form.

Clinical evaluation of patients using the following scales: Mini Mental State Examinaton, Alzheimers Disease Assessment Scale, Neuropsychiatric Inventory Questionnaire, Geriatric Depression Scale, Hachiński Ischemic Index, Rey-RAVLT Fifteen Words Test. Cognitive assessments were performed at baseline, at the end of the procedure (within the three days after the last treatment session), and after 12 weeks of follow-up.

Clinical and demographic data: age, sex, education, the course of the disease to date, comorbidities, medications taken, smoking.

Patients will be randomly assigned to two parallel research groups - an active group receiving combination therapy with tDCS with cognitive exercise and nasal near infrared stimulation and placebo group with tDCS sham without cognitive training and sham nasal stimulation.

The procedure will include daily (5 out of 7 days a week) tDCS sessions lasting a total of 20 minutes. tDCS will be delivered at 2 mA with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively.

During the tDCS procedure, patients received intranasal near-infrared stimulation through the device, utilizing an IR diode with the following parameters: 850nm wavelength, 40Hz pulse frequency, and a 50% duty cycle. Stimulation was administered for 20 minutes, five days a week, consecutively. Both stimulations were administered simultaneously.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 92-213
        • Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • diagnosis of MCI/AD
  • MMSE 12-26 points
  • ADAS- COG > 17 points
  • signed inform consent form
  • minimum 8 years of education
  • stable drug doses for minimum 3 months

Exclusion Criteria:

  • diagnosis of mental disability, schizophrenia, bipolar disorder, depression, alcohol and/or drug addiction,
  • unstable somatic state
  • lack of signed inform consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active tDCS stimulation
50 sessions of active stimulation of current intensity 2mA, stimulation time 20 minutes
Device: tDCS stimulation
tDCS delivered with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively.
Placebo Comparator: Placebo tDCS stimulation
50 sessions of sham stimulation lasting only 30 seconds
Device: tDCS
tDCS delivered with the anode at F3 (according to the 10-20 EEG electrode mounting system) and the cathode in F4, covering the left and right dorsolateral frontal cortexes, respectively.
Active Comparator: Active iNIRS stimulation
50 sessions of active stimulation of intranasal near- infrared of 850 wavelength IR diode
Device: iNIRS stimulation
intra-nasal
Placebo Comparator: Placebo iNIRS stimulation
50 sessions of sham stimulation lasting only 30 seconds
Device: iNIRS
intra-nasal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
cognitive functions assessed by MMSE scale
Time Frame: up to 12 weeks
change over time of cognitive functions measured as a change in amount of points during MMSE scale assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to MMSE scale). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
up to 12 weeks
cognitive functions assessed by ADAS- Cog scale
Time Frame: up to 12 weeks
change over time of cognitive functions measured as a change in amount of points during ADAS-Cog scale assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to ADAS-Cog scale). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
up to 12 weeks
cognitive functions assessed by RAVLT
Time Frame: up to 12 weeks
change over time of cognitive functions measured as a change in amount of points during RAVLT assestment. Change will be evaluated as overall reasult of scale and also as result in every assest field (according to RAVLT). Assessment conducted on baseline, up to 3 days after end of the procedure and after 12 weeks.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNN/336/20/KE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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