Transcranial Direct Current StimulationNCT04328545
Transcranial Direct Current Stimulation Effect on Pain Threshold and Working Memory: Impact of Age and Protocol Type
A study testing Anodal tDCS on DLPFC and Anodal tDCS on M1 in people with Transcranial Direct Current Stimulation and Working Memory, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation, Working Memory, Pain
- What is being tested?
- Anodal tDCS on DLPFC and Anodal tDCS on M1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas e Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: 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.
Read the 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.
- Being tested
- Anodal tDCS on DLPFC, Anodal tDCS on M1, Sham tDCS
- Keywords
- Age Groups, Pain Threshold
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCS on DLPFCDevice
Also called DLPFC
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).
Anodal tDCS on M1Device
Also called 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).
Sham tDCSDevice
Also called Sham
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: up to 60 minutes after tDCS onset
Secondary outcomes (10)
Inhibitory control performance
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.
Measured: up to 60 minutes after tDCS onset
Area under the curve of the ERP during inhibitory control task
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.
Measured: up to 60 minutes after tDCS onset
Heat thermal 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 heat.
Measured: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
Heat pain tolerance
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.
Measured: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
Moderate pain
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).
Measured: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
Unpleasantness sensation
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.
Measured: percentual change from before the tDCS onset, to immediately after the end of tDCS application for each cross-over session
Alpha wave power
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.
Measured: up to 60 minutes after tDCS onset
Beta wave power
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.
Measured: up to 60 minutes after tDCS onset
Theta wave power
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.
Measured: up to 60 minutes after tDCS onset
serum BDNF levels
Neuroplasticity biomarker will be assessed using serum brain-derived neurotrophic factor (BDNF) at baseline to be correlated with tdcs effects on primary outcomes
Measured: up to 60 minutes before tDCS onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Oct 2017
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolnei Caumo, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328545
- Sponsor's protocol ID
- 2017-0188
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2019
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
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.
PubMed 16158065Palm 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.
PubMed 27173384Scharinger 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.
PubMed 26238380Boggio 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.
PubMed 18717717Fregni 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.
PubMed 15999258Saldanha 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.
PubMed 32714178
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04328545
- Acronym / sponsor ID
- 2017-0188
- Keywords
- Age Groups, Pain Threshold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS on DLPFC | Experimental | Device: Anodal tDCS on DLPFCParticipants 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). |
| Anodal tDCS on M1 | Active comparator | Device: Anodal 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). |
| Sham tDCS | Sham comparator | Device: Sham 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. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCS on DLPFCAlso: 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). | Device | Anodal tDCS on DLPFC |
| Anodal tDCS on M1Also: 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). | Device | Anodal tDCS on M1 |
| Sham tDCSAlso: ShamParticipants 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 |
Primary outcome
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.
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).
10 secondary outcomes
Inhibitory control performance
Time frame: 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
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
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
Moderate pain
Time frame: 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
Alpha wave power
Time frame: up to 60 minutes after tDCS onset
Beta wave power
Time frame: up to 60 minutes after tDCS onset
Theta wave power
Time frame: up to 60 minutes after tDCS onset
serum BDNF levels
Time frame: up to 60 minutes before tDCS onset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 16158065Gazzaley 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.
- Background: PubMed 27173384Palm 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.
- Background: PubMed 26238380Scharinger 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.
- Results publication: PubMed 18717717Boggio 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.
- Results publication: PubMed 15999258Fregni 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.
- Derived from this study: PubMed 32714178Saldanha 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolnei Caumo, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS on DLPFC and Anodal tDCS on M1 in people with Transcranial Direct Current Stimulation and Working Memory, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328545, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.