NCT04328545

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

October 31, 2019

Last Update Submit

March 30, 2020

Conditions

Transcranial Direct Current StimulationWorking MemoryPain

Keywords

Age GroupsPain Threshold

Outcome Measures

Primary Outcomes (2)

  • Heat pain Threshold

    Using the Quantitative sensory testing, this measure consists of the average temperature of 3 stimulus with increasing magnitude of heat where the participant presses a button to indicate when he/she first perceives pain.

    percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session

  • Working memory performance

    Working memory performance will be evaluated by a computerized n-back test associated with flankers at baseline and after each session of active tDCS (DLPFC or M1) or sham. The measure of performance is the D' discrimination index (calculated based on hit rate and false alarm rate).

    up to 60 minutes after tDCS onset

Secondary Outcomes (10)

  • Inhibitory control performance

    up to 60 minutes after tDCS onset

  • Area under the curve of the ERP during inhibitory control task

    up to 60 minutes after tDCS onset

  • Heat thermal threshold

    percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session

  • Heat pain tolerance

    percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session

  • Moderate pain

    percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session

  • +5 more secondary outcomes

Study Arms (3)

Anodal tDCS on DLPFC

EXPERIMENTAL

Participants will receive anodal tDCS on the left DLPFC for 30 mins duration, cathode will be placed over the right supra orbital area. The electrodes are 25cm², The stimulation current is 2 milliamperes (2mA).

Device: Anodal tDCS on DLPFC

Anodal tDCS on M1

ACTIVE COMPARATOR

Participants 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).

Device: Anodal tDCS on M1

Sham tDCS

SHAM COMPARATOR

Participants 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.

Device: Sham tDCS

Interventions

Anodal tDCS on DLPFCDEVICE

Participants 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).

Also known as: DLPFC
Anodal tDCS on DLPFC
Anodal tDCS on M1DEVICE

Participants 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).

Also known as: M1
Anodal tDCS on M1
Sham tDCSDEVICE

Participants 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.

Also known as: Sham
Sham tDCS

Eligibility Criteria

Age15 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 15 to 16 years for the adolescent group
  • Age between 30 to 40 years for the young adult group
  • Age between 60 to 70 years for the elderly group
  • From completed elementary school to incomplete superior education
  • right handed

You may not qualify if:

  • Pregnancy
  • Current smoker or previous smoker within 10 years
  • Current Substance Use Disorder
  • Neurological condition (e.g., traumatic brain injury, stroke, brain tumor, epilepsy, brain surgery, brain implant)
  • Any diagnosed Psychiatric condition (e.g., Attention deficit/hyperactivity deficit (ADHD), bipolar disorder, major depressive disorder, schizophrenia, generalized anxiety disorder)
  • Use of any antidepressive or psychoactive, psychostimulant medication
  • Any chronic pain condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clinicas e Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (6)

  • Gazzaley A, Cooney JW, Rissman J, D'Esposito M. Top-down suppression deficit underlies working memory impairment in normal aging. Nat Neurosci. 2005 Oct;8(10):1298-300. doi: 10.1038/nn1543. Epub 2005 Sep 11.

    PMID: 16158065BACKGROUND

  • Palm U, Segmiller FM, Epple AN, Freisleder FJ, Koutsouleris N, Schulte-Korne G, Padberg F. Transcranial direct current stimulation in children and adolescents: a comprehensive review. J Neural Transm (Vienna). 2016 Oct;123(10):1219-34. doi: 10.1007/s00702-016-1572-z. Epub 2016 May 12.

    PMID: 27173384BACKGROUND

  • Scharinger C, Soutschek A, Schubert T, Gerjets P. When flanker meets the n-back: What EEG and pupil dilation data reveal about the interplay between the two central-executive working memory functions inhibition and updating. Psychophysiology. 2015 Oct;52(10):1293-304. doi: 10.1111/psyp.12500. Epub 2015 Aug 3.

    PMID: 26238380BACKGROUND

  • Boggio PS, Zaghi S, Lopes M, Fregni F. Modulatory effects of anodal transcranial direct current stimulation on perception and pain thresholds in healthy volunteers. Eur J Neurol. 2008 Oct;15(10):1124-30. doi: 10.1111/j.1468-1331.2008.02270.x. Epub 2008 Aug 20.

    PMID: 18717717RESULT

  • Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.

    PMID: 15999258RESULT

  • Saldanha JS, Zortea M, Deliberali CB, Nitsche MA, Kuo MF, Torres ILDS, Fregni F, Caumo W. Impact of Age on tDCS Effects on Pain Threshold and Working Memory: Results of a Proof of Concept Cross-Over Randomized Controlled Study. Front Aging Neurosci. 2020 Jun 30;12:189. doi: 10.3389/fnagi.2020.00189. eCollection 2020.

    PMID: 32714178DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wolnei Caumo, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single (participants)
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

March 31, 2020

Study Start

October 1, 2017

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Data will be shared with coded variables and coded participant numbers, only to editors and reviewers of journals where the studies are submitted and registered and under formal request

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Available in August 2019; Available for 3 years
Access Criteria
by e-mail, under request

Locations

BR(1)