Associative Memory in Healthy SubjectsNCT03467698
Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population
A study testing Active tDCS in people with Associative Memory in Healthy Subjects, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Associative Memory in Healthy Subjects
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 21 Oct 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 55 and 75
- Currently not using any medication contradicting with tDCS
- Native English speaker
- Capable of understanding and signing an informed consent
Who cannot join
- Acquainted with the Swahili language or culture
- Severe disease
- Mental illness
- Cardiac history
- History of severe head injuries
- History of epileptic insults
- Any implanted devices such as pace maker, 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 explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.
Read the detailed description
The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.
The aim of this study is to investigate the effects of transcranial Direct Current Stimulation (tDCS) stimulation during a verbal paired-associate learning task to determine if tDCS may be used as a way to enhance brain plasticity during an associative memory task, and to accelerate learning and to optimize associative memory performance. We hypothesize that participants who receive tDCS stimulation will improve their associative memory performance.
- Conditions
- Associative Memory in Healthy Subjects
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Aging, Memory, Associative learning, transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Real stimulation
Sham tDCSDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | active HD-tDCS will be administered Receives: Device: Active tDCS |
| Sham tDCS | Sham comparator | sham HD-tDCS will be administered Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Computerized Verbal Paired-associate Memory Task Will be Used to Assess Memory Performance.
Memory performance scores recorded in the computerized verbal paired-associate memory test during each visit will be compared between the two groups (active tDCS and sham tDCS).
Measured: Memory performance changes will be assessed in two different visits. First assessment (baseline) on visit 1 (learning), then one-week after during visit 2 (memory)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start21 Feb 2018
- Primary completion17 Sep 2022
- Study completion21 Oct 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Associative Memory in Healthy SubjectsStudies 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 two groups: (1) active tDCS (2) Sham tDCS.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 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, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467698
- Sponsor's protocol ID
- 18-40
- Status last verified
- Dec 2023
- First submitted
- 28 Feb 2018
- Last updated
- 9 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Luckey AM, McLeod SL, Robertson IH, To WT, Vanneste S. Greater Occipital Nerve Stimulation Boosts Associative Memory in Older Individuals: A Randomized Trial. Neurorehabil Neural Repair. 2020 Nov;34(11):1020-1029. doi: 10.1177/1545968320943573. Epub 2020 Sep 23.
PubMed 32964776
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Transcranial Direct Current Stimulation (tDCS) in Accelerating Learning in a Healthy Older Population
- ClinicalTrials.gov ID
- NCT03467698
- Acronym / sponsor ID
- 18-40
- Conditions
- Associative Memory in Healthy Subjects
- Keywords
- Aging, Memory, Associative learning, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 16 Mar 2018 (actual)
- Results
- Posted 9 Jan 2024
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 explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.
Detailed description
The overall objective of this study is to explore whether transcranial Direct Current Stimulation (tDCS) can accelerate associative learning and boost associative memory in healthy subjects.
The aim of this study is to investigate the effects of transcranial Direct Current Stimulation (tDCS) stimulation during a verbal paired-associate learning task to determine if tDCS may be used as a way to enhance brain plasticity during an associative memory task, and to accelerate learning and to optimize associative memory performance. We hypothesize that participants who receive tDCS stimulation will improve their associative memory performance.
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 two groups: (1) active tDCS (2) Sham tDCS.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCSactive HD-tDCS will be administered |
| Sham tDCS | Sham comparator | Device: Sham tDCSsham HD-tDCS will be administered |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 55 and 75
- Currently not using any medication contradicting with tDCS
- Native English speaker
- Capable of understanding and signing an informed consent
Key exclusion criteria (8 listed)
- Acquainted with the Swahili language or culture
- Severe disease
- Mental illness
- Cardiac history
- History of severe head injuries
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 tDCSReal stimulation | Device | Active tDCS |
| Sham tDCSSham stimulation | Device | Sham tDCS |
Primary outcome
A Computerized Verbal Paired-associate Memory Task Will be Used to Assess Memory Performance.
Time frame: Memory performance changes will be assessed in two different visits. First assessment (baseline) on visit 1 (learning), then one-week after during visit 2 (memory)
Memory performance scores recorded in the computerized verbal paired-associate memory test during each visit will be compared between the two groups (active tDCS and sham tDCS).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32964776Luckey AM, McLeod SL, Robertson IH, To WT, Vanneste S. Greater Occipital Nerve Stimulation Boosts Associative Memory in Older Individuals: A Randomized Trial. Neurorehabil Neural Repair. 2020 Nov;34(11):1020-1029. doi: 10.1177/1545968320943573. Epub 2020 Sep 23.
- Individual participant dataSharing planned: No
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, PhD 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 tDCS in people with Associative Memory in Healthy Subjects, 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 4 inclusion and 8 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 9 Jan 2024. 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 9 Jan 2024). 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?
A Computerized Verbal Paired-associate Memory Task Will be Used to Assess Memory Performance. (time frame: Memory performance changes will be assessed in two different visits. First assessment (baseline) on visit 1 (learning), then one-week after during visit 2 (memory)). 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 NCT03467698, which also lists 1 linked publication.
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 9 Jan 2024.