Healthy AdultsNCT03138590
Investigating Accelerated Learning in Healthy Subjects: Trigeminal Nerve Stimulation
A study testing Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS in people with Healthy Adults, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate learning task 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?
- Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to 25 Jan 2022
- 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
Who cannot join
- History of severe head injuries, epileptic insults, or heart disease.
- Severe psychiatric disorders and severe untreated medical problems
- Acquainted with the foreign language used in the learning task
- Contraindications for tDCS (e.g. pregnant, implanted devices)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas of Dallas
Richardson, Texas, 75080
About this study
Official title: Investigating Accelerated Learning in Healthy Subjects
The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate learning task
Read the detailed description
Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.
Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether it is possible to accelerate learning and improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 2 groups will be compared. The first group will get active tDCS during the verbal paired-associate learning task. The second group will get sham tDCS during the verbal paired-associate learning task.
- Conditions
- Healthy Adults
- Being tested
- Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS
- Keywords
- transcranial Direct Current Stimulation (tDCS), accelerate learning, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUSDevice
Transcranial Direct Current Stimulation targeting the trigeminal nerve
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Active transcranial Direct Current Stimulation targeting the trigeminal nerve Receives: Device: Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS |
| Sham tDCS | Sham comparator | Sham transcranial Direct Current Stimulation targeting the trigeminal nerve Receives: Device: Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associative Memory Assessed by a Verbal Paired-Associate Test
Changes in performance in the Verbal Paired-Associate memory task is compared between the 2 groups (1. Active tDCS 2. Sham tDCS) to investigate the influence of tDCS on Associative Memory.
Measured: 1 week after stimualtion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start4 Apr 2017
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Why it stopped: No relevant anymore
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 2 groups: (1) active tDCS (2) sham tDCS
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 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
- NCT03138590
- Sponsor's protocol ID
- 17-34 TN
- Status last verified
- Jan 2022
- First submitted
- 28 Apr 2017
- Last updated
- 3 Feb 2022
- 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 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Accelerated Learning in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03138590
- Acronym / sponsor ID
- 17-34 TN
- Conditions
- Healthy Adults
- Keywords
- transcranial Direct Current Stimulation (tDCS), accelerate learning, memory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No relevant anymore
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 11 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS) targeting the trigeminal nerve during a verbal paired-associate learning task
Detailed description
Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.
Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether it is possible to accelerate learning and improve associative memory using tDCS, the performance in a Verbal Paired-Associate memory task of 2 groups will be compared. The first group will get active tDCS during the verbal paired-associate learning task. The second group will get sham tDCS during the verbal paired-associate learning task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- participants will be randomly assigned to one of 2 groups: (1) active tDCS (2) sham tDCS
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUSActive transcranial Direct Current Stimulation targeting the trigeminal nerve |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUSSham transcranial Direct Current Stimulation targeting the trigeminal nerve |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Native English Speaker
Key exclusion criteria (4 listed)
- History of severe head injuries, epileptic insults, or heart disease.
- Severe psychiatric disorders and severe untreated medical problems
- Acquainted with the foreign language used in the learning task
- Contraindications for tDCS (e.g. pregnant, implanted devices)
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 |
|---|---|---|
| Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUSTranscranial Direct Current Stimulation targeting the trigeminal nerve | Device | Active tDCS, Sham tDCS |
Primary outcome
Associative Memory Assessed by a Verbal Paired-Associate Test
Time frame: 1 week after stimualtion
Changes in performance in the Verbal Paired-Associate memory task is compared between the 2 groups (1. Active tDCS 2. Sham tDCS) to investigate the influence of tDCS on Associative Memory.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Healthy Participants
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 Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Feb 2022. 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 11 Sep 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?
Associative Memory Assessed by a Verbal Paired-Associate Test (time frame: 1 week after stimualtion). 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 3 Feb 2022.