Improving Cognition in Schizophrenia Using tDCS

NCT02539797 | Completed Results

• 1 other identifier: 22017
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the benefits of transcranial direct current stimulation (tDCS), a new tool that is being developed as a safe and non-invasive neurostimulation method, for improving neurocognitive and social cognitive functions in schizophrenia. This procedure is non-invasive and painless and it results in increase or decrease of spontaneous neuronal firing in the brain. Its safety and beneficial effect on cognition has been demonstrated in healthy individuals and several clinical populations. In this pilot study, the investigators will examine the effect of tDCS on cognitive functions in 40 individuals with schizophrenia. Each participant will arrive for three visits, with approximately one week between each visit. During the first visit, participants will be interviewed about their psychiatric symptoms, personal life experiences, and emotional well being by a specially-trained interviewer. On each of the three visits, participants will receive one of three stimulations: a type of tDCS designed to increase neuronal firing, an alternative form of tDCS designed to decrease neuronal firing, and a sham tDCS (stimulation with no current). Immediately following the stimulation, participants will be asked to complete measures of mental abilities, including tests presented on a computer screen and paper-and-pencil tests. During each visit, participants will also undergo a standard measure of brain activity (EEG) while listening to tones. The first visit will last approximately five hours, and the other two visits will last approximately four hours each. The project will take approximately two years to complete.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Cognition on MCCB

  Summary score of the cognitive domains on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). Four nonsocial neurocognitive tasks were included: speed of processing, working memory, verbal memory, and reasoning/problem solving. Normed T-scores were calculated for each cognitive subdomain, as well as the cognitive composite score consisting of the average across the four subdomains. The T-scores have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of higher cognition.

  baseline and 20 minutes

• Change From Baseline in Managing Emotions on MSCEIT

  Total score on the Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) The test consists of 141 items and 8 ability subtests, which assess four components of emotional processing. In this study, only branches 1 and 4 were administered, focusing on the Managing Emotions component. The total score reflects mean performance across the branches. The scores were converted to normed T-scores that have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of better performance.

  baseline and 20 minutes

Study Arms (3)

tDCS anodal stimulation

EXPERIMENTAL

anodal stimulation

Device: tDCS

tDCS cathodal stimulation

ACTIVE COMPARATOR

cathodal stimulation

Device: tDCS

Sham stimulation

SHAM COMPARATOR

Sham stimulation. Termination of electrical stimulation following 30 seconds

Device: tDCS

Interventions

tDCS DEVICE

comparing anodal, cathodal, and sham tDCS

Sham stimulation; tDCS anodal stimulation; tDCS cathodal stimulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-V Diagnosis of Schizophrenia
• Must understand spoken English sufficiently to comprehend testing procedures
• Estimated premorbid intelligence quotient (IQ) \> 70 (based on reading ability)
• Ongoing care of a Psychiatrist, Psychologist, or other qualified mental health professional

You may not qualify if:

• Metal in cranium
• Cardiac lines/pacemaker
• Medication pump
• Increased intracranial pressure
• Lifetime history of serious head injury (LOC \> 1 hr.)
• Sedatives or Benzodiazepines within 12 hours of testing
• Clinically significant neurological disease (e.g., seizures)
• History of mental retardation or developmental disability
• Alcohol or substance dependence in the last 6 months
• Alcohol or substance abuse in the last 1 month
• Change in medication in past 6 weeks
• Change in in living situation in the last 2 months
• Inpatient hospitalization in past 3 months
• Participation in prior studies involving tDCS

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Rassovsky Y, Dunn W, Wynn JK, Wu AD, Iacoboni M, Hellemann G, Green MF. Single transcranial direct current stimulation in schizophrenia: Randomized, cross-over study of neurocognition, social cognition, ERPs, and side effects. PLoS One. 2018 May 7;13(5):e0197023. doi: 10.1371/journal.pone.0197023. eCollection 2018.

  PMID: 29734347 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

The present findings employed a single tDCS administration, which may be insufficient to attain potential therapeutic effects. These findings thus add to the growing body of evidence suggesting the need for basic dose-finding studies in tDCS.

Results Point of Contact

• Title: Dr. Yuri Rassovsky
• Organization: University of California, Los Angeles

yurir@ucla.edu

3104783711

Study Officials

• Yuri Rassovsky, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Psychologist

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: September 3, 2015
• Study Start: October 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 7, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-02

Locations

US (1)