N/A
N=33
Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis
Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT02085421 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Brief Assessment of Cognition in Schizophrenia (BACS) From Baseline to Post-Training — -0.67; -1.68 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tDCS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Brief Assessment of Cognition in Schizophrenia (BACS) From Baseline to Post-Training |
-0.67; -1.68 | — |
| PRIMARY Change in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) From Baseline to Post-Training |
12.67; 11 | — |
| PRIMARY Change in the D-prime Score of the N-Back Working Memory Test From Baseline to Post-Training |
1.99; 1.42 | — |
| SECONDARY N-Back - Post Training 2-back Number of Hits Provided Here |
39.88; 38.88 | — |
| SECONDARY N-Back - Post Training 2-back Number of False Alarms Provided Here |
24.75; 49.63 | — |
Summary
The proposed pilot study is a randomized controlled study to assess effectiveness of transcranial direct current stimulation (tDCS) to enhance cognitive remediation therapy in patients with psychotic disorders. tDCS. Patients will be randomized into two arms: active tDCS vs. sham tDCS. The active tDCS will be applied at a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (3 cm x 4.5 cm) applied to the side of the head. The investigators hypothesis is that the use of tDCS will enhance the improvement seen with cognitive remediation therapy.
Eligibility Criteria
Inclusion Criteria
- Meet diagnostic criteria for schizophrenia or schizoaffective disorder
- Are age 18-64
- Fluent in written and spoken English
- Have an outpatient status of at least 1 month prior to participation
- Has been on a stable dose of psychiatric medication for at least one month prior to participation
Exclusion Criteria
- History of seizures or epilepsy
- Metallic cranial plates, screws, or implanted devices
- History of craniotomy
- History of stroke
- History of eczema on scalp
- Pre-existing sores or lesions at sites of tDCS electrode placement
- Non removable facial piercings
- Current or possibility of current pregnancy
- Has received a clinically meaningful dose of a targeted cognitive training intervention in the last 12 months
Data sourced from ClinicalTrials.gov (NCT02085421). 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.