tDCS and Cognitive Efficiency in Ageing

NCT05216315 | Completed Results DMC

• 1 other identifier: H1526539449220
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (3)

• Complutense Verbal Learning Test (TAVEC) - Memory

  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.

  Baseline to approximately 4 weeks

• Digits Wechsler Intelligence Scale for Adults-III (WAIS-III)

  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.

  Baseline to approximately 4 weeks

• Mini Mental State Examination

  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.

  Baseline to approximately 4 weeks

Secondary Outcomes (1)

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

  Baseline to approximately 4 weeks

Other Outcomes (3)

• Global Deterioration Scale (GDS)

  Baseline to approximately 4 weeks

• Memory Alteration Test (M@T) - Cognitive Impairment

  Baseline to approximately 4 weeks

• Experimental Task - Recognition Familiarity and False Alarms

  Baseline to approximately 4 weeks

Study Arms (2)

tDCS. Transcranial direct current stimulation

EXPERIMENTAL

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).

Device: Transcranial direct current stimulation (tDCS)

Sham stimulation

SHAM COMPARATOR

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

Device: Sham stimulation

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

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

Also known as: Transcranial direct current stimulation

tDCS. 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

Also known as: Transcranial direct current stimulation

Sham stimulation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Faculty of Psychology

Valencia, 46010, Spain

Location

Related Publications (8)

• 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.

  PMID: 27160468 BACKGROUND

• 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.

  PMID: 30615905 BACKGROUND

• 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.

  PMID: 30503376 BACKGROUND

• 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.

  PMID: 26597929 BACKGROUND

• 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.

  PMID: 33354206 BACKGROUND

• 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.

  PMID: 31998111 BACKGROUND

• 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.

  PMID: 32199339 BACKGROUND

• 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.

  PMID: 26607412 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr Juan C Melendez
• Organization: University of Valencia

melendez@uv.es

+34 963983844

Study Officials

• Juan C Melendez

  University of Valencia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Doctoral Programme in Psychogerontology: Life Cycle Perspective

Model Details: sham versus stimulation

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 31, 2022
• Study Start: July 30, 2020
• Primary Completion: December 30, 2021
• Study Completion: May 30, 2023
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)