tDCS for Cognitive Enhancement
(MINUTES Trial)

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Minnesota

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. In particular, tDCS may have a critical role to play in generalization, that is how training in one domain generalizes to unlearned or unpracticed domains. This problem has resonance for disorders with cognitive deficits, such as schizophrenia. Understanding how tDCS affects brain circuity is critical to the design and application of effective interventions, especially if the effects are different for healthy vs. psychiatric populations. In previous research, one clue to the mechanism underlying increased learning and generalization with tDCS was provided by neuroimaging data from subjects with schizophrenia undergoing cognitive training where increases in thalamocortical (prefrontal) functional connectivity (FC) predicted greater generalization. The premise of this proposal is that increases in thalamocortical FC are associated with the generalization of cognitive training, and tDCS facilitates these increases. The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups. Study 1 will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 (NCT03896438) will be similar in all aspects but will examine 90 patients with schizophrenia or schizoaffective disorder and include clinical assessments. Results of the study will provide crucial information about location of stimulation, length of treatment, modeled dosage, trajectory and durability needed to guide future research and interventions for cognitive impairments.

Research Team

Eligibility Criteria

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.

Inclusion 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.

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Exclusion Criteria

Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: The research team will utilize the CMRR Center's screening tools and adhere to the screening SOP during enrollment of all research participants in this protocol. The CMRR Center's screening tools and SOP are IRB approved under the CMRR Center Grant (HSC# 1406M51205) and information regarding screening procedures is publicly available on the CMRR website (CMRR Policies / Procedures).

I have a condition or received treatment that affected my nervous system.

Treatment Details

Interventions

Transcranial Direct Current Stimulation (tDCS) (Electrical Stimulation)

Trial OverviewThe 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.

Participant Groups

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.

Transcranial Direct Current Stimulation (tDCS) is already approved in Canada for the following indications:

Approved in Canada as Transcranial Direct Current Stimulation for:

Depression
Stroke rehabilitation
Chronic pain management
Research use for various neurological and psychiatric conditions including autism spectrum disorder