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tDCS + Cognitive Training for Improved Decision Making (tDCS-CTDM Trial)

N/A

Recruiting

Led By Najat Khalifa, MD

Research Sponsored by Dr. Najat Khalifa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Consenting volunteers aged between 18 and 40.

Consenting volunteers aged between 18 and 40

Must not have

Individuals receiving psychotropic medication

Individuals with epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline after 20 minutes of combined cognitive training and tdcs stimulation

Summary

This trial will test if a brain stimulation technique called tDCS combined with cognitive training can improve decision making and impulse control.

Who is the study for?

This trial is for consenting adults aged 18 to 40 who want to help study decision-making and impulsivity. It's not suitable for those with epilepsy, other neurological conditions, significant head injury history, substance misuse issues, major mental disorders, or those on psychotropic medication.

What is being tested?

The study tests if brain stimulation (anodal tDCS) combined with cognitive training improves decision-making and impulse control compared to a fake treatment (sham tDCS). Participants will do tasks like the Iowa Gambling Task while receiving these treatments.

What are the potential side effects?

tDCS may cause mild side effects such as tingling, itching or discomfort at the electrode site. Cognitive training has no known side effects but can be mentally taxing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 40 years old and agree to participate.

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I am between 18 and 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication for my mental health.

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I have epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Iowa Gambling Task (IGT) net scores

Secondary study objectives

Abbreviated Profile of Mood States (POMS) Total Mood Disturbance score

Stop Signal Task (SST) reaction time

Urgency, Perseveration, Premeditation, Sensation Seeking + Positive Urgency (UPPS+P) Impulsive Behavior Scale total scores

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Combined anodal tDCS and cognitive trainingExperimental Treatment2 Interventions

Combined anodal tDCS and cognitive training. Anodal tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). Anodal tDCS will use a constant current of 2mA, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively. The duration of each tDCS session will be 20 minutes.

Group II: Combined sham tDCS and cognitive trainingPlacebo Group2 Interventions

Combined sham tDCS and cognitive training. Sham tDCS will be delivered while the participant is completing the cognitive training task (Iowa Gambling Task). For sham tDCS, the current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The duration of each tDCS session will be 20 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive training

2019

Completed Phase 3

~1480

0 / 4Eligibility criteria met