tDCS and Cognitive Efficiency

Alzheimer Disease Clinical Trial

— FRtDCS  

Official title:

Non-invasive Transcranial Direct Current Stimulation to Improve Cognitive Efficiency

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05216315
• Other study ID #: H1526539449220
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Transcranial direct current stimulation (tDCS)
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.10 sessions

Locations

Country	Name	City	State
Spain	Juan C Melendez	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & 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. Review. — View Citation

Deldar Z, Rustamov N, Blanchette I, Piché 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Deterioration Scale (GDS)	This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.	15 minutes
Other	Memory alteration test (M@T)	This cognitive test is evaluated on a maximum of 50 points. The optimal cut-off point for distinguishing mild cognitive impairment of the amnesiac type from subjective memory complaints is 37 points. The optimal cut-off point for Alzheimer's disease is 31 points.	5 minutes
Primary	Complutense Verbal Learning Test (TAVEC)	The evaluator reads a 16-word shopping list in five different essays and in each of them the evaluated person must mention those words that he or she remembers. After 20 minutes, the subject is asked to remember them again	20 minutes
Primary	Digits Wechsler Intelligence Scale for Adults-III (WAIS-III)	The digits forward task assesses immediate recall. It requires the participant to repeat a sequence of numbers in the same order in which they were read. On the digits backward task, the subject must repeat a sequence of numbers in the reverse order of their presentation. The task is used to assess working memory.	5 minutes
Primary	Experimental task - Recognition familiarity and false alarms	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, z (List A) or i, o, c, f, h, l, m, p, s, t, v, 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.	15 minutes
Secondary	MMSE	This test is evaluated on a maximum of 30 points. Participants with scores equal to or below 23 would be considered cognitively deficient.	5-10 minutes
Secondary	Barcelona test (BT)	In this test, the subject is considered to have a good categorical evocation when he is able to evoke more than 16 animals in 1 minute and a good verbal fluency when he is able to evoke more than 19 words beginning with "p" in 3 minutes	5 minutes