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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

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

Other trials in United States

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 groups in NCT03869489
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.

Nov 2019Apr 2020

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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.

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?

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?

On the ClinicalTrials.gov record for NCT03869489.

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.