NCT05216315: FRtDCS

tDCS and Cognitive Efficiency in Ageing

Completed NA Results posted Last updated 19 December 2024

What this trial tests

NA trial testing Transcranial direct current stimulation (tDCS) in Aging in 38 participants. Completed in 30 May 2023.

Timeline

30 July 2020

Primary endpoint
30 December 2021

30 May 2023

Quick facts

Lead sponsor	University of Valencia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	38
Start date	30 July 2020
Primary completion	30 December 2021
Estimated completion	30 May 2023
Sites	1 location across Spain

Drugs / interventions tested

• Transcranial direct current stimulation (tDCS)
• Sham stimulation

Conditions studied

• Aging — all drugs for Aging →
• Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

University of Valencia

Who can join

65 and older, any sex, with Aging or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complutense Verbal Learning Test (TAVEC) - Memory Primary · 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.

Trial 1

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	0.94	± 0.35
Sham Stimulation	-0.81	± 0.03

Trial 5

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	1.65	± 0.5
Sham Stimulation	-0.31	± 0.4

Digits Wechsler Intelligence Scale for Adults-III (WAIS-III) Primary · 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

Direct Digits

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	1.35	± 0.62
Sham Stimulation	-0.18	± 0.84

Inverse digits

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	0.17	± 1.15
Sham Stimulation	-0.43	± 0.05

Mini Mental State Examination Primary · 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.

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	2.18	± 0.03
Sham Stimulation	-0.44	± 1.28

Barcelona Test (BT) - Ability to Access and Recall Elements From the Lexical and Semantic Store Secondary · 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 consid

Semantic fluency

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	0.47	± 4.47
Sham Stimulation	-5.72	± 4.22

Phonological fluency

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	1.77	± 0.1
Sham Stimulation	0.69	± 0.46

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

Group	Value	95% CI
tDCS. Transcranial Direct Current Stimulation	6.06	± 2.19
Sham Stimulation	-0.88	± 1.7

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Potential for Neuromodulation in the Treatment of Alzheimer's Disease: A Review of Clinical Trials.
   Jones T, Shalom M, Chalamgari A, Gold J, et al · · 2025 · PMID 40599507 · DOI 10.7759/cureus.85156