- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328545
Transcranial Direct Current Stimulation Effect on Pain Threshold and Working Memory: Impact of Age and Protocol Type
March 30, 2020 updated by: Hospital de Clinicas de Porto Alegre
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
- Hospital de Clinicas e Porto Alegre (HCPA)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 70 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anodal tDCS on DLPFC
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).
|
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).
Other Names:
|
ACTIVE_COMPARATOR: Anodal tDCS on M1
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).
|
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).
Other Names:
|
SHAM_COMPARATOR: Sham tDCS
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heat pain Threshold
Time Frame: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
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
Time Frame: up to 60 minutes after tDCS onset
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inhibitory control performance
Time Frame: up to 60 minutes after tDCS onset
|
A computerized stop-signal task associated with flankers will evaluate inhibitory control.
Performance index are calculated with the D' discrimination index (based on hits and false alarms for go and stop trials).
The task will be performed at baseline and after the stimulation on each cross-over session.
|
up to 60 minutes after tDCS onset
|
Area under the curve of the ERP during inhibitory control task
Time Frame: up to 60 minutes after tDCS onset
|
Area under the curve of the signal of event-related potential (ERP) evoked during the stop signal task with flankers (inhibitory control performance).
The signal will be assessed using an 8 channel EEG device at baseline and after each cross-over session.
|
up to 60 minutes after tDCS onset
|
Heat thermal threshold
Time Frame: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
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 heat.
|
percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
Heat pain tolerance
Time Frame: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
Using the Quantitative sensory testing, this measure consists of the temperature for a stimulus with increasing magnitude of heat where the participant presses a button to indicate the maximum heat tolerated.
|
percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
Moderate pain
Time Frame: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
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 pain perceived at a moderate level, i.e. level of 6 in a numeric pain scale (0 to 10).
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percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
Unpleasantness sensation
Time Frame: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
This measure will be assessed using a numeric pain scale (0 to 10 in which 0 represents no unpleasant sensation and 10 extremely unpleasant sensation) with which participant will indicate how unpleasant was the temperature of the quantitative sensory testing stimulus for the heat pain threshold.
|
percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
|
Alpha wave power
Time Frame: up to 60 minutes after tDCS onset
|
Assessment of alpha wave power (8Hz to 12Hz) will be done using an 8 channel EEG device during an "eyes-open and eyes-closed" paradigm where participant is in a resting state at baseline and after each cross-over session.
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up to 60 minutes after tDCS onset
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Beta wave power
Time Frame: up to 60 minutes after tDCS onset
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Assessment of beta wave power (12Hz to 25Hz) will be done using an 8 channel EEG device during an "eyes-open and eyes-closed" paradigm where participant is in a resting state at baseline and after each cross-over session.
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up to 60 minutes after tDCS onset
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Theta wave power
Time Frame: up to 60 minutes after tDCS onset
|
Assessment of theta wave power (4Hz to 8Hz) will be done using an 8 channel EEG device during an "eyes-open and eyes-closed" paradigm where participant is in a resting state at baseline and after each cross-over session.
|
up to 60 minutes after tDCS onset
|
serum BDNF levels
Time Frame: up to 60 minutes before tDCS onset
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Neuroplasticity biomarker will be assessed using serum brain-derived neurotrophic factor (BDNF) at baseline to be correlated with tdcs effects on primary outcomes
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up to 60 minutes before tDCS onset
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Nat Neurosci. 2005 Dec;8(12):1791.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2017
Primary Completion (ACTUAL)
February 28, 2020
Study Completion (ACTUAL)
February 28, 2020
Study Registration Dates
First Submitted
October 31, 2019
First Submitted That Met QC Criteria
March 30, 2020
First Posted (ACTUAL)
March 31, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 30, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-0188 (IRB ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
IPD Sharing Time Frame
Available in August 2019; Available for 3 years
IPD Sharing Access Criteria
by e-mail, under request
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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