MedDataX Logo

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).

NCT ID: NCT07290686

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo iNIRS stimulation

50 sessions of sham stimulation lasting only 30 seconds

Group Type PLACEBO_COMPARATOR

iNIRS

Intervention Type DEVICE

intra-nasal

Active tDCS stimulation

50 sessions of active stimulation of current intensity 2mA, stimulation time 20 minutes

Group Type ACTIVE_COMPARATOR

tDCS stimulation

Intervention Type DEVICE

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 tDCS stimulation

50 sessions of sham stimulation lasting only 30 seconds

Group Type PLACEBO_COMPARATOR

tDCS

Intervention Type DEVICE

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 iNIRS stimulation

50 sessions of active stimulation of intranasal near- infrared of 850 wavelength IR diode

Group Type ACTIVE_COMPARATOR

iNIRS stimulation

Intervention Type DEVICE

intra-nasal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

iNIRS stimulation

intra-nasal

Intervention Type DEVICE

iNIRS

intra-nasal

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jakub Kazmierski

MD PhD Professor of Medical University of Lodz

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RNN/336/20/KE

Identifier Type: -

Identifier Source: org_study_id