Skip to main content
OpenTrials
Completed

NCT Number: NCT05216315

tDCS and Cognitive Efficiency in Ageing

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Psychology

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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

Other names: Transcranial direct current stimulation

Sham stimulation

Device

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

Other names: Transcranial direct current stimulation

Primary outcomes

  1. Complutense Verbal Learning Test (TAVEC) - Memory

    Time frame: Baseline to approximately 4 weeks

    This test presents a list of 16 words that, after being read by the evaluator, have to be repeated by the participant. The list is repeated five times (trials); the participant is again asked to remember the 16 words. The test was administered to evaluate the participant's immediate memory (Trial 1), learning ability (Trial 5 ). Post-intervention minus baseline. Scale is scored 0-16. Difference score range is (-16 to 16) with positive scores reflecting improvement.

  2. Digits Wechsler Intelligence Scale for Adults-III (WAIS-III)

    Time frame: Baseline to approximately 4 weeks

    Direct and inverse digits of the Wechsler Intelligence Scale for Adults-III (Wechsler, 2001). These tests assess attentional capacity by exposing the participant to increasing amounts of information. On the direct digits task, which is used to assess immediate recall, the subject must repeat the sequence of numbers in the same order in which they are read by the examiner. On the inverse digit task, which assesses working memory and mental flexibility, the subject must say the digits backwards from the way they were presented by the examiner. Both tests are evaluated in the same way, assigning one point for each correct item, with a maximum score of 16 for both tests. Post-intervention minus baseline. Difference score range is (-16 to 16) with positive scores reflecting improvement.

  3. Mini Mental State Examination

    Time frame: Baseline to approximately 4 weeks

    This is a screening test for general cognitive status. This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient. Post-intervention minus baseline. Scale is scored 0-30. Difference score range is (-30 to 30) with positive scores reflecting improvement.

Secondary outcomes

  1. Barcelona Test (BT) - Ability to Access and Recall Elements From the Lexical and Semantic Store

    Time frame: Baseline to approximately 4 weeks

    Barcelona Test assesses the ability to access and recall lexical and semantic items by means of two subtests: a. Semantic fluency: recall the highest number of words from the category 'animals' in one minute; b. Phonological fluency: recall the highest number of words beginning with the letter 'p' in three minutes. Minimum and maximum range for Semantic fluency and Phonological fluency: 0 to n (no upper limit). Method of calculation: Scores for each subtest are reported separately. No combined scores or averages between subtests are calculated. Interpretation: Good categorical recall is considered good when evoking more than 16 animals in 1 minute and good verbal fluency when evoking more than 19 words beginning with 'p' in 3 minutes. This test assesses the ability to access and recall items from the lexical and semantic store. Processes involved: processing speed, cognitive flexibility and working memory. Post-intervention less baseline with positive scores reflecting improvement.

Other outcomes

  1. Global Deterioration Scale (GDS)

    Time frame: Baseline to approximately 4 weeks

    This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.

  2. Memory Alteration Test (M@T) - Cognitive Impairment

    Time frame: Baseline to approximately 4 weeks

    This test offers a rapid and effective screening with excellent discriminative properties for amnestic Mild Cognitive Impairment (MCI-A) and early AD in the general primary care population. The test assesses a variety of abilities such as encoding, orientation, semantic memory and free recall. It consists of oral questions with only one possible answer, and the maximum achievable score is 50 points. The optimal cut-off point for distinguishing amnestic-like mild cognitive impairment from subjective memory complaints is 37 points. The optimal cut-off point for Alzheimer's disease is 31 points. Post-intervention minus baseline. Scale is scored 0-50. Difference score range is (-50 to 50) with positive scores reflecting improvement.

  3. Experimental Task - Recognition Familiarity and False Alarms

    Time frame: Baseline to approximately 4 weeks

    This experimental task is composed by three lists of words with two conditions: half and entire.

    The half condition included two lists of 50 words each, formed entirely from the following letters of the Spanish alphabet: a, e, u, b, d, g, j, n, r, and z (list A) or i, o, c, f, h, l, m, p, s, t, v, and y (list B).

    List C (entire condition) contained 50 words formed from the entire alphabet, with the only criterion being that each word had to contain at least one letter from list A and at least one letter from list B.

    In the half condition, the recognition estimates for each participant were derived by subtracting the proportion of false alarms on words with the same letters, as in the study list, from the proportion of hits, whereas in the entire condition, the recognition estimates were derived by subtracting the proportion of false alarms on words with all the letters in the alphabet from the proportion of hits as a way to control the response bias of the participants.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Non-invasive Transcranial Direct Current Stimulation to Improve Cognitive Efficiency

Acronym: FRtDCS

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jan 31, 2022
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.