Healthy AdultsNCT03319134
Investigating the Neural Correlates in Memory Retrieval After HD-tDCS
A study testing active anodal HD-tDCS and active cathodal HD-tDCS in people with Healthy Adults, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
The overall objective of this study is to investigate the neural correlate in retrieval memory task. The aim of the study is to understand the undergoing changes in late positive ERP component during retrieval memory task when stimulating the posterior cingulate cortex (PCC) with High Definition Transcranial Direct… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- active anodal HD-tDCS and active cathodal HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2017to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Native English Speaker
- Currently not using any medication
- Capable of understanding and signing an informed consent
Who cannot join
- Severe disease
- Mental illness
- Cardiac history
- History of severe head injuries
- History of epileptic seizures
- Any implanted devices such as pacemaker, neurostimulator
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Dallas
Richardson, Texas, 75080
About this study
The overall objective of this study is to investigate the neural correlate in retrieval memory task.
The aim of the study is to understand the undergoing changes in late positive ERP component during retrieval memory task when stimulating the posterior cingulate cortex (PCC) with High Definition Transcranial Direct Current Stimulation (HD-tDCS).
Read the detailed description
Retrieval memory is supported by distinct retrieval process known as recollection and familiarity. These two process have been associated with distinct event related potentials (ERPs). At the time of retrieval, familiarity is associated with modulation of the FN400, an enhanced positivity for old items relative to new items observed from approximately 400-600ms post stimulus onset. The FN400 tends to have mid-frontal scalp distribution which can extend to left and right frontal areas and central midline regions. In contrast, recollection has been linked with modulation of positive going waveform that emerges approximately 600ms post stimulus and is typically maximal over parietal sites and referred to as late positive component (LPC). In addition, FN400 is found to increase gradually as a function of item retrieval confidence whereas LPC is limited to high confidence retrieval response.
High Definition transcranial Direct Current Stimulation (HD-tDCS ) is a non-invasive neuromodulation technique. Compared to the standard bipolar montage used by the conventional tDCS, it uses arrays of smaller, specially designed electrodes to deliver a constant and low current directly to the cortical brain areas to increase the spatial focality. Studies show that the cortical area undergoing stimulation with HD-tDCS is more restricted compared to the standard bipolar montage of conventional tDCS. Moreover, tDCS has been proposed as a therapeutic procedure in various diseases and tDCS in healthy adults have demonstrated to improve cognitive and memory performance, but information regarding the effects of HD-tDCS targeting the PCC and its impact on memory retrieval is scarce. By targeting the PCC area by HD-tDCS, we want to introduce a safer, easier-to-use and more accurate non-invasive neuromodulation procedure. The dysfunctions of posterior cingulate cortex hav been linked to a range of psychiatric and neurological condition such as Alzheimer's disease, schizophrenia, autism, depression and attention deficit hyperactivity disorder, as well as aging. It shows increased activity when subject retrieve autobiographical memories suggests its internal orientated function. PET and ERP combined studies have shown greater blood flow medial temporal lobe with a brief late positive ERP component in PCC. Therefore, in this study we aim to understand whether HD-tDCS targeting the PCC can modulate the late positive ERP component.
- Conditions
- Healthy Adults
- Being tested
- active anodal HD-tDCS, sham HD-tDCS, active cathodal HD-tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active anodal HD-tDCSDevice
- active anodal HD-tDCS with memory task
sham HD-tDCSDevice
- sham HD-tDCS with memory task
active cathodal HD-tDCSDevice
- active cathodal HD-tDCS with memory task
| Study group | Role | What they receive |
|---|---|---|
| active anodal HD-tDCS | Experimental | Active anodal HD-tDCS stimulation applied during memory task Receives: Device: active anodal HD-tDCS |
| sham HD-tDCS | Sham comparator | Sham HD-tDCS stimulation during memory task for comparison Receives: Device: sham HD-tDCS |
| active cathodal HD-tDCS | Experimental | Active cathodal HD-tDCS stimulation applied during memory task Receives: Device: active cathodal HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition Memory Assessed by a Retrieval Memory Experiment
Participants had to learn an association between a face and a name. The face-name association memory task was divided into (1) an encoding phase, (2) a consolidation phase, and (3) a retrieval phase. During the encoding phase, participants studied 60 successively presented face-name pairs. Participants were instructed to assess the gender of each face shown to keep participants focused on the task. The encoding phase lasted approximately 5 minutes. This is followed by a consolidation phase where participants were instructed to "sit still, relax, and think about nothing in particular" for 10 minutes. During the retrieval phase, participants were presented with 60 old and 60 new faces and were instructed to assess whether they had seen this face during the encoding phase, or if it was a 'new' face. Participants received active or sham transcranial direct current stimulation targetting the posterior cingulate cortex during retrieval. The outcome is correctly recalled old faces.
Measured: Retrieval Memory is assessed after 90 seconds break following the recognition phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start18 Sep 2017
- Primary completion1 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three groups: (1) active HD-tDCS with retrieval memory task, (2) sham HD-tDCS with retrieval memory task, (3) active cathodal HD-tDCS with retrieval memory task
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sven Vanneste, The University of Texas at Dallas
- Investigators
- Sven Vanneste, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319134
- Sponsor's protocol ID
- 18-01
- Status last verified
- Aug 2020
- First submitted
- 18 Oct 2017
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neural Correlates in Memory Retrieval After HD-tDCS
- ClinicalTrials.gov ID
- NCT03319134
- Acronym / sponsor ID
- 18-01
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to investigate the neural correlate in retrieval memory task.
The aim of the study is to understand the undergoing changes in late positive ERP component during retrieval memory task when stimulating the posterior cingulate cortex (PCC) with High Definition Transcranial Direct Current Stimulation (HD-tDCS).
Detailed description
Retrieval memory is supported by distinct retrieval process known as recollection and familiarity. These two process have been associated with distinct event related potentials (ERPs). At the time of retrieval, familiarity is associated with modulation of the FN400, an enhanced positivity for old items relative to new items observed from approximately 400-600ms post stimulus onset. The FN400 tends to have mid-frontal scalp distribution which can extend to left and right frontal areas and central midline regions. In contrast, recollection has been linked with modulation of positive going waveform that emerges approximately 600ms post stimulus and is typically maximal over parietal sites and referred to as late positive component (LPC). In addition, FN400 is found to increase gradually as a function of item retrieval confidence whereas LPC is limited to high confidence retrieval response.
High Definition transcranial Direct Current Stimulation (HD-tDCS ) is a non-invasive neuromodulation technique. Compared to the standard bipolar montage used by the conventional tDCS, it uses arrays of smaller, specially designed electrodes to deliver a constant and low current directly to the cortical brain areas to increase the spatial focality. Studies show that the cortical area undergoing stimulation with HD-tDCS is more restricted compared to the standard bipolar montage of conventional tDCS. Moreover, tDCS has been proposed as a therapeutic procedure in various diseases and tDCS in healthy adults have demonstrated to improve cognitive and memory performance, but information regarding the effects of HD-tDCS targeting the PCC and its impact on memory retrieval is scarce. By targeting the PCC area by HD-tDCS, we want to introduce a safer, easier-to-use and more accurate non-invasive neuromodulation procedure. The dysfunctions of posterior cingulate cortex hav been linked to a range of psychiatric and neurological condition such as Alzheimer's disease, schizophrenia, autism, depression and attention deficit hyperactivity disorder, as well as aging. It shows increased activity when subject retrieve autobiographical memories suggests its internal orientated function. PET and ERP combined studies have shown greater blood flow medial temporal lobe with a brief late positive ERP component in PCC. Therefore, in this study we aim to understand whether HD-tDCS targeting the PCC can modulate the late positive ERP component.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three groups: (1) active HD-tDCS with retrieval memory task, (2) sham HD-tDCS with retrieval memory task, (3) active cathodal HD-tDCS with retrieval memory task
| Arm | Type | Receives |
|---|---|---|
| active anodal HD-tDCS | Experimental | Device: active anodal HD-tDCSActive anodal HD-tDCS stimulation applied during memory task |
| sham HD-tDCS | Sham comparator | Device: sham HD-tDCSSham HD-tDCS stimulation during memory task for comparison |
| active cathodal HD-tDCS | Experimental | Device: active cathodal HD-tDCSActive cathodal HD-tDCS stimulation applied during memory task |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Native English Speaker
- Currently not using any medication
- Capable of understanding and signing an informed consent
Key exclusion criteria (7 listed)
- Severe disease
- Mental illness
- Cardiac history
- History of severe head injuries
- History of epileptic seizures
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 |
|---|---|---|
| active anodal HD-tDCS1) active anodal HD-tDCS with memory task | Device | active anodal HD-tDCS |
| sham HD-tDCS2) sham HD-tDCS with memory task | Device | sham HD-tDCS |
| active cathodal HD-tDCS3) active cathodal HD-tDCS with memory task | Device | active cathodal HD-tDCS |
Primary outcome
Recognition Memory Assessed by a Retrieval Memory Experiment
Time frame: Retrieval Memory is assessed after 90 seconds break following the recognition phase.
Participants had to learn an association between a face and a name. The face-name association memory task was divided into (1) an encoding phase, (2) a consolidation phase, and (3) a retrieval phase. During the encoding phase, participants studied 60 successively presented face-name pairs. Participants were instructed to assess the gender of each face shown to keep participants focused on the task. The encoding phase lasted approximately 5 minutes. This is followed by a consolidation phase where participants were instructed to "sit still, relax, and think about nothing in particular" for 10 minutes. During the retrieval phase, participants were presented with 60 old and 60 new faces and were instructed to assess whether they had seen this face during the encoding phase, or if it was a 'new' face. Participants received active or sham transcranial direct current stimulation targetting the posterior cingulate cortex during retrieval. The outcome is correctly recalled old faces.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Sven Vanneste principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active anodal HD-tDCS and active cathodal HD-tDCS in people with Healthy Adults, run by The University of Texas at Dallas at 1 site in United States.
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 3 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 26 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recognition Memory Assessed by a Retrieval Memory Experiment (time frame: Retrieval Memory is assessed after 90 seconds break following the recognition phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2020.