Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1 (MINUTES)

University of Minnesota (UMN)

Status: Completed

Conditions: Healthy; Transcranial Direct Current Stimulation

Treatments: Device: Transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03896425

1RF1MH116987-01 (U.S. NIH Grant/Contract)

PSYCH-2018-26586_01

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Ability to provide consent and comply with study procedures.
2. Age 18 - 60 years old.
3. Estimated IQ range within the range: 70 ≤ IQ ≤ 115.
4. No Serious and Persistent Mental Illness (SPMI) or addictive disorder diagnosis as measured by the MINI (Mini International Neuropsychiatric Interview), or sleep disorder;
5. Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.

Exclusion criteria

1. Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
2. 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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73 participants in 3 patient groups

right active-tDCS

Experimental group

Description:

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.

Treatment:

Device: Transcranial direct current stimulation (tDCS)

left active-tDCS

Experimental group

Description:

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.

Treatment:

Device: Transcranial direct current stimulation (tDCS)

sham tDCS

Sham Comparator group

Description:

Current will be turned off immediately after the initial 30-second ramp-up period.

Treatment:

Device: Transcranial direct current stimulation (tDCS)