Verbal Learning and MemoryEarly Phase 1NCT01733576
High-definition Transcranial Direct Current Stimulation (HD-tDCS) Verbal Learning
A Early Phase 1 study testing HD-tDCS in people with Verbal Learning and Memory, run by The University of New South Wales at 1 site in Australia.
Trial summary
This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Verbal Learning and Memory
- What is being tested?
- HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- Start not givento Mar 2014
- Phase
- Early Phase 1
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 - 40 years
- Right-handed
Who cannot join
- concurrent medication likely to affect mental performance
- current history of drug or alcohol abuse or dependence
- any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Verbal Learning and Memory Using High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the brain important for learning and memory will improve verbal learning and memory compared to sham HD-tDCS.
- Conditions
- Verbal Learning and Memory
- Being tested
- HD-tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCSDevice
| Study group | Role | What they receive |
|---|---|---|
| Sham HD-tDCS | Sham comparator | Not described Receives: Device: HD-tDCS |
| Active HD-tDCS 1 | Active comparator | Not described Receives: Device: HD-tDCS |
| Active HD-tDCS 2 | Active comparator | Not described Receives: Device: HD-tDCS |
| Active HD-tDCS 3 | Active comparator | Not described Receives: Device: HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ray Auditory Verbal Learning Test (RAVLT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Primary completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Verbal Learning and MemoryStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Pigot, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733576
- Sponsor's protocol ID
- CB64
- Status last verified
- Jul 2015
- First submitted
- 26 Nov 2012
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Verbal Learning and Memory Using High-Definition Transcranial Direct Current Stimulation (HD-tDCS)
- ClinicalTrials.gov ID
- NCT01733576
- Acronym / sponsor ID
- CB64
- Conditions
- Verbal Learning and Memory
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Primary completion
- Mar 2014 (actual)
- First posted
- 27 Nov 2012 (estimated)
- 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.
This project will use a new form of non-invasive brain stimulation called high-definition transcranial direct current stimulation (HD-tDCS) to facilitate verbal learning. This form of stimulation is similar to transcranial direct current stimulation (tDCS) but allows for more spatially focused stimulation. We hypothesise that HD-tDCS when applied to regions of the brain important for learning and memory will improve verbal learning and memory compared to sham HD-tDCS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham HD-tDCS | Sham comparator | Device: HD-tDCS |
| Active HD-tDCS 1 | Active comparator | Device: HD-tDCS |
| Active HD-tDCS 2 | Active comparator | Device: HD-tDCS |
| Active HD-tDCS 3 | Active comparator | Device: HD-tDCS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ages 18 - 40 years
- Right-handed
Key exclusion criteria (3 listed)
- concurrent medication likely to affect mental performance
- current history of drug or alcohol abuse or dependence
- any psychiatric or neurological disorder, recent head injury, or history of seizure or stroke.
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 |
|---|---|---|
| HD-tDCS | Device | Active HD-tDCS 1, Active HD-tDCS 2, Active HD-tDCS 3, Sham HD-tDCS |
Primary outcome
Ray Auditory Verbal Learning Test (RAVLT)
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 23 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HD-tDCS in people with Verbal Learning and Memory, run by The University of New South Wales at 1 site in Australia.
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 2 inclusion and 3 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 23 Jul 2015. 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 Australia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Ray Auditory Verbal Learning Test (RAVLT). 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 23 Jul 2015.