Transcranial Electrical Stimulation for Schizophrenia
(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(NCT03896425) will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 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

This trial is for individuals aged 18-60 with schizophrenia or schizoaffective disorder, who are stable on medications and can commit to a 12-week training program. They must have an IQ within the range of 70-115, no addictive or sleep disorders, and be able to consent to study procedures. People with medical conditions affecting the brain or those unable to undergo tDCS or MRI scans cannot participate.

Inclusion Criteria

You cannot have a current addiction or sleep disorder as determined by a special interview.

Ability to provide consent and comply with study procedures.

My health condition and medications have been stable for at least a month.

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Exclusion Criteria

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

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).

Treatment Details

Interventions

Transcranial Direct Current Stimulation (tDCS) (Electrical Stimulation)

Trial OverviewThe study tests how transcranial direct current stimulation (tDCS) affects cognitive function in people with and without psychosis. It involves neuroimaging and cognitive testing during tDCS sessions alongside cognitive training over a period of 12 weeks, aiming to understand its impact on brain connectivity.

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