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tDCS and Cognitive Efficiency in Ageing

NCT ID: NCT05216315

Last Updated: 2024-12-19

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2023-05-30

Brief Summary

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Normal aging is associated with a progressive decline in cognitive functions, especially memory. This decline in cognitive function can negatively impact the quality of life of older adults. Although there are currently few possibilities to prevent and/or slow the signs of cognitive decline, both those associated with age and neurodegenerative pathologies, one of the non-invasive brain stimulation techniques that has gained attention in recent years is Transcranial Direct Current Stimulation (tDCS). tDCS is a technique based on the application of a low-intensity (\< 2 mA) direct electrical current between two large-area electrodes placed on various surface areas of the head. Moreover, according to safety-related meta-analyses it is a very safe technique, without any major side effects, provided that internationally established safety protocols are taken into account in its application. This technique has recently been investigated as a potential treatment for both healthy elderly people and people with mild cognitive impairment and Alzheimer's disease in several cognitive variables, having shown encouraging results in working memory learning curves, modulation of plasticity and recognition tasks. This project aims to implement an intervention using transcranial direct current stimulation in healthy older adults, MCI and AD. The main objective is to test if there is an improvement in cognitive efficiency and if the changes are maintained over time (1 month). For this purpose, the effect of the technique will be studied on participants assigned to treatment and control groups, analyzing the possible modifications in the following cognitive variables: cognitive plasticity and learning potential, recognition and familiarity and false alarms.

Detailed Description

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The clinical trial protocol involves the recruitment of participants from three different groups: healthy older adults, individuals with mild cognitive impairment (MCI), and patients with Alzheimer's disease (AD). Participants will be randomly assigned to either a treatment group or a control group.

For the treatment group, transcranial direct current stimulation (tDCS) will be administered over a specified period using a standard protocol involving the application of low-intensity electrical current (\< 2 mA) through electrodes placed on specific scalp areas. The duration and frequency of stimulation will be predetermined based on scientific literature and established safety recommendations.

The control group will receive a sham procedure where a low-intensity current, having no effect on neuronal activity, will be applied to maintain treatment masking.

Prior to commencing the intervention, a baseline assessment of participants' cognitive functions will be conducted using a battery of standardized tests, including measures of cognitive plasticity, memory, attention, executive functions, and other relevant cognitive abilities.

During the intervention period, regular tDCS or placebo sessions will be conducted according to participants' assigned groups. Additionally, data on potential side effects and tolerability of the technique will be collected.

At the end of the intervention period, a post-treatment assessment will be conducted to determine any changes in participants' cognitive functions. These data will be compared to baseline assessments to ascertain the intervention's efficacy.

Furthermore, participants will be followed up for a period of at least one month after the intervention to evaluate the persistence of effects and any potential long-term effects.

It is important to emphasize that this protocol will adhere to all ethical and safety regulations established by relevant regulatory authorities and ethics committees. Participants will be fully informed about the procedures and risks involved, and their informed consent will be obtained before their participation in the study.

Conditions

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Aging Mild Cognitive Impairment Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

sham versus stimulation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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tDCS. Transcranial direct current stimulation

The stimulation time was 20 minutes, with an initial and final ramp of 30 seconds so that the participant could adapt to the sensation of the current. 10 sessions. Constant current intensity of 2 mA The anode was placed on position F3, coinciding with the dorsolateral prefrontal cortex, and the cathode was placed on Fp2, coinciding with the right supraorbital area (rSO).

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)

Sham stimulation

The sham group received direct current only on the ramps to generate a sensation of the effect.

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions

Interventions

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Transcranial direct current stimulation (tDCS)

10 sessions of tDCS stimulation on dorsolateral prefrontal cortex with the apparatus HDC stimulator (Newronika TM)

Intervention Type DEVICE

Sham stimulation

The sham group received direct current only on the ramps to generate a sensation of the effect.10 sessions

Intervention Type DEVICE

Other Intervention Names

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Transcranial direct current stimulation Transcranial direct current stimulation

Eligibility Criteria

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Inclusion Criteria

For the group of healthy older adults:

* MEC score greater than 26 points.
* GDS between 1 and 3.

For the MCI group:

* MEC score between 21 and 26 points.
* GDS between 1 and 3.

For the mild EA group:

* MEC score between 18 and 23 points.
* GDS between 3 and 4.

Exclusion Criteria

* Presentation of contraindications to tDCS (presence of intracranial metal implants, intracranial hypertension, comitial risk).
* Significant asymptomatic neurovascular disease
* History of previous symptomatic stroke
* Alcohol or drug abuse/dependence
* Severe psychiatric symptoms
* Depressive symptoms higher than mild
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Juan Carlos Melendez

Coordinator of Doctoral Programme in Psychogerontology: Life Cycle Perspective

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan C Melendez

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

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Faculty of Psychology

Valencia, , Spain

Site Status

Countries

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Spain

References

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Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12.

Reference Type BACKGROUND
PMID: 27160468 (View on PubMed)

Deldar Z, Rustamov N, Blanchette I, Piche M. Improving working memory and pain inhibition in older persons using transcranial direct current stimulation. Neurosci Res. 2019 Nov;148:19-27. doi: 10.1016/j.neures.2018.12.007. Epub 2019 Jan 4.

Reference Type BACKGROUND
PMID: 30615905 (View on PubMed)

Galli G, Vadillo MA, Sirota M, Feurra M, Medvedeva A. A systematic review and meta-analysis of the effects of transcranial direct current stimulation (tDCS) on episodic memory. Brain Stimul. 2019 Mar-Apr;12(2):231-241. doi: 10.1016/j.brs.2018.11.008. Epub 2018 Nov 17.

Reference Type BACKGROUND
PMID: 30503376 (View on PubMed)

Hill AT, Fitzgerald PB, Hoy KE. Effects of Anodal Transcranial Direct Current Stimulation on Working Memory: A Systematic Review and Meta-Analysis of Findings From Healthy and Neuropsychiatric Populations. Brain Stimul. 2016 Mar-Apr;9(2):197-208. doi: 10.1016/j.brs.2015.10.006. Epub 2015 Oct 23.

Reference Type BACKGROUND
PMID: 26597929 (View on PubMed)

Huo L, Zheng Z, Huang J, Li R, Li J, Li J. Transcranial Direct Current Stimulation Enhances Episodic Memory in Healthy Older Adults by Modulating Retrieval-Specific Activation. Neural Plast. 2020 Dec 5;2020:8883046. doi: 10.1155/2020/8883046. eCollection 2020.

Reference Type BACKGROUND
PMID: 33354206 (View on PubMed)

Nissim NR, O'Shea A, Indahlastari A, Kraft JN, von Mering O, Aksu S, Porges E, Cohen R, Woods AJ. Effects of Transcranial Direct Current Stimulation Paired With Cognitive Training on Functional Connectivity of the Working Memory Network in Older Adults. Front Aging Neurosci. 2019 Dec 16;11:340. doi: 10.3389/fnagi.2019.00340. eCollection 2019.

Reference Type BACKGROUND
PMID: 31998111 (View on PubMed)

Perceval G, Martin AK, Copland DA, Laine M, Meinzer M. Multisession transcranial direct current stimulation facilitates verbal learning and memory consolidation in young and older adults. Brain Lang. 2020 Jun;205:104788. doi: 10.1016/j.bandl.2020.104788. Epub 2020 Mar 19.

Reference Type BACKGROUND
PMID: 32199339 (View on PubMed)

Summers JJ, Kang N, Cauraugh JH. Does transcranial direct current stimulation enhance cognitive and motor functions in the ageing brain? A systematic review and meta- analysis. Ageing Res Rev. 2016 Jan;25:42-54. doi: 10.1016/j.arr.2015.11.004. Epub 2015 Nov 30.

Reference Type BACKGROUND
PMID: 26607412 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H1526539449220

Identifier Type: -

Identifier Source: org_study_id