Effects on LearningNCT01339585
The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training
A study testing Transcranial direct current stimulation (tDCS) in people with Effects on Learning, run by The University of New South Wales at 1 site in Australia.
Trial summary
This project will investigate a novel strategy for enhancing cognitive training (CT). Specifically, the investigators aim to combine a non-invasive form of brain stimulation (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be administered either before or during CT. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects on Learning
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- May 2011to May 2014
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants will be healthy right-handed subjects aged 18 to 40 years.
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
This project will investigate a novel strategy for enhancing cognitive training (CT). Specifically, the investigators aim to combine a non-invasive form of brain stimulation (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be administered either before or during CT.
- Conditions
- Effects on Learning
- Being tested
- Transcranial direct current stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Eldith Direct Current Stimulator (NeuroConn GmbH, Germany)
| Study group | Role | What they receive |
|---|---|---|
| Timing of tDCS | Experimental | Not described Receives: Device: Transcranial direct current stimulation (tDCS) |
| Alternative timing of tDCS | Experimental | Not described Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance across each condition.
D prime, number of correct responses, and number of errors.
Measured: Over 2 days, with each condition conducted 1 month apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects on LearningStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT01339585
- Sponsor's protocol ID
- HREC 11064
- Status last verified
- Aug 2014
- First submitted
- 1 Apr 2011
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Timing of Transcranial Direct Current Stimulation (tDCS) for Enhancing Learning During Cognitive Training
- ClinicalTrials.gov ID
- NCT01339585
- Acronym / sponsor ID
- HREC 11064
- Conditions
- Effects on Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (actual)
- First posted
- 20 Apr 2011 (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 investigate a novel strategy for enhancing cognitive training (CT). Specifically, the investigators aim to combine a non-invasive form of brain stimulation (tDCS) with CT. This study will examine the optimal time interval - whether tDCS should be administered either before or during CT.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Timing of tDCS | Experimental | Device: Transcranial direct current stimulation (tDCS) |
| Alternative timing of tDCS | Experimental | Device: Transcranial direct current stimulation (tDCS) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants will be healthy right-handed subjects aged 18 to 40 years.
Key exclusion criteria (4 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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Eldith Direct Current Stimulator (NeuroConn GmbH, Germany) | Device | Alternative timing of tDCS, Timing of tDCS |
Primary outcome
Change in performance across each condition.
Time frame: Over 2 days, with each condition conducted 1 month apart.
D prime, number of correct responses, and number of errors.
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 12 Aug 2014.
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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 study testing Transcranial direct current stimulation (tDCS) in people with Effects on Learning, 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 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: finished, as of the sponsor's last update on 12 Aug 2014. 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. 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?
Change in performance across each condition. (time frame: Over 2 days, with each condition conducted 1 month apart.). 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 12 Aug 2014.