Clinical Trials Directory

Trials / Completed

CompletedNCT04328545

Transcranial Direct Current Stimulation Effect on Pain Threshold and Working Memory: Impact of Age and Protocol Type

Transcranial Direct Current Stimulation Effect on Pain Threshold and Working Memory in Healthy Adolescents, Young Adults and Elderly: a Randomized , Cross-over, Single Blind Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Hospital de Clinicas de Porto Alegre · Academic / Other
Sex
Female
Age
15 Years – 70 Years
Healthy volunteers
Accepted

Summary

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation method which has great potential as an aid in the therapeutic management of neuropsychiatric disorders and chronic pain syndromes. However, despite promising results, the response to stimulation presents great variability among subjects. Age is a factor that is known to influence the tDCS effect forging the inconsistency of clinical effect.The purpose of this study is to evaluate the effect of tDCS on pain perception and working memory in healthy women from 3 different age groups: adolescents, young adults and elderly. This is a randomized, single-blinded, cross-over study of 2 different active interventions and sham.

Detailed description

Transcranial direct current stimulation (tDCS) is a neuromodulation method that has great potential as an aid in the therapeutic management of neuropsychiatric disorders and chronic pain syndromes. tDCS modulates the neuronal membrane potential , facilitating neuronal depolarization or hyperpolarization, hence modifying the cortical excitability of the stimulated area. However, despite promising results the response to stimulation presents great variability among subjects. Chronological age is an important factor in the variation of brain plasticity. The dorsolateral prefrontal cortex (DLPFC) is associated with cognitive and emotional aspects of pain, in addition to being related to executive components of working memory. Anodal tDCS on DLPFC modulates pain level in patients with chronic pain and modifies working memory performance in healthy subjects and patients with memory impairment. The prefrontal cortex presents a great structural difference throughout lifespan: it is under maturational process in the adolescence, reaching peak of maturation in the adult life, and initiating process of cerebral senescence in elderly subjects. Therefore, the use of tDCS on DLPFC in these three age groups presents potential for a large variation in response. Faced with the potential of tDCS for adjuvant use in the treatment of several diseases, it is imperative to understand the variability of this intervention between different age groups. This knowledge may allow the optimization of neuromodulation protocols, allowing more careful and refined use in the clinic. The study primary outcomes is the difference between and within age groups on the variation of pre and post tDCS on pain threshold evaluated by Heath pain threshold on a Quantitative sensory testing paradigm and working memory performance evaluated by n-back test in healthy subjects of three age groups: adolescents, young adults, elderly. This is a randomized, single blinded, cross-over, sham-controlled clinical trial. The study will be conducted at the Clinical Research Center of the Hospital de Clínicas of Porto Alegre (HCPA). It will include 30 women, 10 women by age group: adolescents between 15 and 16 years,young adults between 30 and 40 years old and elderly women between 60 and 70 years. Participants will be randomized for a cross-over of three sessions: anodal stimulation in DLPFC, anodal stimulation in primary motor cortex (M1) as active control and sham stimulation.

Conditions

Interventions

TypeNameDescription
DEVICEAnodal tDCS on DLPFCParticipants will receive anodal tDCS on the left DLPFC for 30 min duration, cathode will be placed over the right supra orbital area. The electrodes are 25cm², The stimulation current is 2 milliamperes (2mA).
DEVICEAnodal tDCS on M1Participants will receive anodal tDCS on the left M1 for 30 min duration, cathode will be placed over the right supra orbital area. The electrodes are 25cm², The stimulation current is 2 milliamperes (2mA).
DEVICESham tDCSParticipants will receive sham tDCS. The anode will be placed on the left DLPFC and the cathode on the over the right supra orbital area. The electrodes are 25cm², There will be a ram up and down of 30 seconds each, after the ramp up the current will be turned off.

Timeline

Start date
2017-10-01
Primary completion
2020-02-28
Completion
2020-02-28
First posted
2020-03-31
Last updated
2020-03-31

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT04328545. Inclusion in this directory is not an endorsement.