CognitionANeMATENCT03224559

Applying Neuromodulation to Accelerate Training Effects

An observational study of Cognition, run by University of Minnesota at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This study seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cognition
What is being tested?: Transcranial Electrical Stimulation
Type of treatment: Medical device
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2019to 30 May 2021
Phase: Observational
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Healthy volunteers, 18-65 years old

Who may be able to join

People may participate in the experiment if they have normal or corrected vision, are in good health, and are at least 18 years old.

Who cannot join

People will be screened and excluded from participation if they are currently ill or if they report any history of seizures, if they lack the capacity to consent or appear to lack capacity to consent, if they have participated in previous thinking skills training or brain stimulation, or if they are currently taking certain substances/medications that might change thinking skills.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

This study seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Read the detailed description

This study uses noninvasive electrical stimulation delivered through seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Conditions: Cognition
Being tested: Transcranial Electrical Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Electrical StimulationDevice
Also called XCITE 100 (Pulvinar Neuro)
Transcranial Electrical Stimulation

Study groups in NCT03224559
Study group	Role	What they receive
Sham Stimulation		subject receives minimal transcranial electrical stimulation Receives: Device: Transcranial Electrical Stimulation
Left Side Stimulation		transcranial electrical stimulation on the left side of the head. Receives: Device: Transcranial Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Working memory
Working Memory
Measured: Baseline through 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201930 May 2021

First posted21 Jul 2017
Study start1 Sep 2019 (estimated)
Primary completion30 May 2020 (estimated)
Study completion30 May 2021 (estimated)

Why it stopped: Enrollment never began.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CognitionStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03224559
Sponsor's protocol ID: STUDY00001248
Acronym: ANeMATE
Status last verified: Nov 2019
First submitted: 16 Jun 2017
Last updated: 12 Nov 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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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All Cognition trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Applying Neuromodulation to Accelerate Training Effects
ClinicalTrials.gov ID: NCT03224559
Acronym / sponsor ID: ANeMATE / STUDY00001248
Conditions: Cognition
Study type: Observational
Recruitment status: WithdrawnReason stopped: Enrollment never began.
Enrolment: 0 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 1 Sep 2019 (estimated)
Primary completion: 30 May 2020 (estimated)
Study completion: 30 May 2021 (estimated)
First posted: 21 Jul 2017 (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.

This study seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Sham Stimulation	–	Device: Transcranial Electrical Stimulationsubject receives minimal transcranial electrical stimulation
Left Side Stimulation	–	Device: Transcranial Electrical Stimulationtranscranial electrical stimulation on the left side of the head.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Healthy volunteers, 18-65 years old

Key inclusion criteria (1 listed)

People may participate in the experiment if they have normal or corrected vision, are in good health, and are at least 18 years old.

Key exclusion criteria (1 listed)

People will be screened and excluded from participation if they are currently ill or if they report any history of seizures, if they lack the capacity to consent or appear to lack capacity to consent, if they have participated in previous thinking skills training or brain stimulation, or if they are currently taking certain substances/medications that might change thinking skills.

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 Electrical StimulationAlso: XCITE 100 (Pulvinar Neuro)Transcranial Electrical Stimulation	Device	Left Side Stimulation, Sham Stimulation

Primary outcome

Change in Working memory
Time frame: Baseline through 2 months
Working Memory

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 12 Nov 2019.

Related trials for Cognition

Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Recruiting
Rural Veteran and Care Partner Walking Program
Mild Cognitive Impairment (MCI)
Not yet recruitingPhase 1
Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
Sickle Cell Disease, Cognitive Impairment
Not yet recruiting
Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity
Mild Cognitive Impairment (MCI)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury

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.

Angus W MacDonald, PhD principal investigator

University of Minnesota

Joshua E Mervis, BA principal investigator

University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cognition, run by University of Minnesota 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 1 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 12 Nov 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. 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?

Change in Working memory (time frame: Baseline through 2 months). 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 NCT03224559.

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 Nov 2019.