Cognitive ChangeNCT03869489
Decision Making in Video Games
A study testing Anodal left dorsolateral prefrontal cortex tDCS stimulation and Anodal right dorsolateral prefrontal cortex tDCS stimulation in people with Cognitive Change, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex induces approach motivation, and whether anodal tDCS applied to the right dorsolateral prefrontal cortex induces avoidance motivation. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Anodal left dorsolateral prefrontal cortex tDCS stimulation and Anodal right dorsolateral prefrontal cortex tDCS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2019to Apr 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal hearing and vision
Who cannot join
- Left-handedness
- History of seizure, head injury (including neurosurgery), brain injury, diagnosis or a neurological or psychiatric disorder, metal in the head, sensitive scalp
- History of anxiolytic and/or antidepressant medications
- Participation in Experiment #1 or Experiment #2 of the larger study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Applied Brain and Cognitive Sciences
Medford, Massachusetts, 02155
About this study
The purpose of this study is to determine whether anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex induces approach motivation, and whether anodal tDCS applied to the right dorsolateral prefrontal cortex induces avoidance motivation. This study consists of three experiments: one in which an approach/avoidance video game is validated, one in which the effect of anger and fear on approach/avoidance is studied, and one in which the effect of tDCS is studied. Only the experiment in which the effect of tDCS is studied involves tDCS.
- Conditions
- Cognitive Change
- Being tested
- Anodal left dorsolateral prefrontal cortex tDCS stimulation, Anodal right dorsolateral prefrontal cortex tDCS stimulation, Sham tDCS stimulation
- Keywords
- approach motivation, avoidance motivation, transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal left dorsolateral prefrontal cortex tDCS stimulationDevice
Anodal tDCS will be applied to the left dorsolateral prefrontal cortex of participants
Anodal right dorsolateral prefrontal cortex tDCS stimulationDevice
Anodal tDCS will be applied to the right dorsolateral prefrontal cortex of participants
Sham tDCS stimulationDevice
Sham tDCS stimulation will be applied
| Study group | Role | What they receive |
|---|---|---|
| Anodal left dorsolateral prefrontal cortex tDCS stimulation | Experimental | Not described Receives: Device: Anodal left dorsolateral prefrontal cortex tDCS stimulation |
| Anodal right dorsolateral prefrontal cortex tDCS stimulation | Experimental | Not described Receives: Device: Anodal right dorsolateral prefrontal cortex tDCS stimulation |
| Sham tDCS stimulation | Sham comparator | Not described Receives: Device: Sham tDCS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Avoidance-Approach time difference
Median of the difference between time to approach and time to avoid a stimulus
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study startNov 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Funding Goals changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869489
- Sponsor's protocol ID
- 1809016
- Status last verified
- Aug 2019
- First submitted
- 8 Mar 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: N/A. Study withdrawn
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Making in Video Games
- ClinicalTrials.gov ID
- NCT03869489
- Acronym / sponsor ID
- 1809016
- Conditions
- Cognitive Change
- Keywords
- approach motivation, avoidance motivation, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding Goals changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 11 Mar 2019 (actual)
- 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.
The purpose of this study is to determine whether anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex induces approach motivation, and whether anodal tDCS applied to the right dorsolateral prefrontal cortex induces avoidance motivation. This study consists of three experiments: one in which an approach/avoidance video game is validated, one in which the effect of anger and fear on approach/avoidance is studied, and one in which the effect of tDCS is studied. Only the experiment in which the effect of tDCS is studied involves tDCS.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal left dorsolateral prefrontal cortex tDCS stimulation | Experimental | Device: Anodal left dorsolateral prefrontal cortex tDCS stimulation |
| Anodal right dorsolateral prefrontal cortex tDCS stimulation | Experimental | Device: Anodal right dorsolateral prefrontal cortex tDCS stimulation |
| Sham tDCS stimulation | Sham comparator | Device: Sham tDCS stimulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal hearing and vision
Key exclusion criteria (4 listed)
- Left-handedness
- History of seizure, head injury (including neurosurgery), brain injury, diagnosis or a neurological or psychiatric disorder, metal in the head, sensitive scalp
- History of anxiolytic and/or antidepressant medications
- Participation in Experiment #1 or Experiment #2 of the larger study
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 |
|---|---|---|
| Anodal left dorsolateral prefrontal cortex tDCS stimulationAnodal tDCS will be applied to the left dorsolateral prefrontal cortex of participants | Device | Anodal left dorsolateral prefrontal cortex tDCS stimulation |
| Anodal right dorsolateral prefrontal cortex tDCS stimulationAnodal tDCS will be applied to the right dorsolateral prefrontal cortex of participants | Device | Anodal right dorsolateral prefrontal cortex tDCS stimulation |
| Sham tDCS stimulationSham tDCS stimulation will be applied | Device | Sham tDCS stimulation |
Primary outcome
Avoidance-Approach time difference
Time frame: 1 year
Median of the difference between time to approach and time to avoid a stimulus
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Individual participant dataSharing planned: No. N/A. Study withdrawn
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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 Anodal left dorsolateral prefrontal cortex tDCS stimulation and Anodal right dorsolateral prefrontal cortex tDCS stimulation in people with Cognitive Change, run by Tufts University 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: withdrawn, as of the sponsor's last update on 4 Sep 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Avoidance-Approach time difference (time frame: 1 year). 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 4 Sep 2019.