N/A
Completed N=38
Improving Cognition in Schizophrenia Using tDCS
Source: ClinicalTrials.gov NCT02539797 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Change From Baseline in Cognition on MCCB — 45.0; 45.2; 45.8 T-scores
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cognition on MCCB |
45.0; 45.2; 45.8 | — |
| PRIMARY Change From Baseline in Managing Emotions on MSCEIT |
36.4; 37.7; 37.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02539797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.