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Electrical Stimulation
tDCS for Cognitive Enhancement (MINUTES Trial)
N/A
Waitlist Available
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 - 60 years old.
Be between 18 and 65 years old
Must not have
Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; mid-test (week 6); post-test (week 12);follow up (week 24).
Awards & highlights
Summary
This trial will test transcranial direct current stimulation (tDCS) as a tool to improve cognition in healthy people and people with schizophrenia. tDCS sends a low current through the brain to stimulate or modulate neuronal activity. This study will test whether tDCS can increase cognitive abilities and whether these increases generalize to other domains.
Who is the study for?
Healthy individuals aged 18-60, with an IQ between 70 and 115, who can commit to three weekly training sessions over 12 weeks and four assessments. They must not have serious mental illnesses or addictive disorders, sleep disorders, or any medical condition affecting the brain like a stroke.Check my eligibility
What is being tested?
The study is testing how transcranial direct current stimulation (tDCS) affects cognitive function when paired with cognitive training. It will explore changes in brain connectivity in healthy subjects over a period of 12 weeks using different tDCS settings.See study design
What are the potential side effects?
Potential side effects of tDCS may include mild itching, tingling on the scalp during application, headache, fatigue after treatment sessions. Serious side effects are rare but could involve seizures if predisposed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition or received treatment that affected my nervous system.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; mid-test (week 6); post-test (week 12);follow up (week 24).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; mid-test (week 6); post-test (week 12);follow up (week 24).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in DPX task performance
Changes in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) composite score
Changes in N-back task performance
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: right active-tDCSExperimental Treatment1 Intervention
2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA right (AF4 anode - AF3 cathode) for 20 min, and then ramp-down for 30 seconds.
Group II: left active-tDCSExperimental Treatment1 Intervention
2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA left (AF3 anode - AF4 cathode) for 20 min, and then ramp-down for 30 seconds.
Group III: sham tDCSPlacebo Group1 Intervention
Current will be turned off immediately after the initial 30-second ramp-up period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial direct current stimulation (tDCS)
2016
Completed Phase 3
~870
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,746 Total Patients Enrolled
2 Trials studying Transcranial Direct Current Stimulation
208 Patients Enrolled for Transcranial Direct Current Stimulation
University of MinnesotaLead Sponsor
1,395 Previous Clinical Trials
1,553,252 Total Patients Enrolled
1 Trials studying Transcranial Direct Current Stimulation
85 Patients Enrolled for Transcranial Direct Current Stimulation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend three 45-minute training sessions weekly for 12 weeks and go to four assessments.Ability to provide consent and comply with study procedures.No significant mental illness or addiction, as measured by the MINI, and no sleep disorder.Your IQ score should be between 70 and 115.I am between 18 and 60 years old.I have a condition or received treatment that affected my nervous system.
Research Study Groups:
This trial has the following groups:- Group 1: sham tDCS
- Group 2: right active-tDCS
- Group 3: left active-tDCS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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