N/A
N=50
The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Schizophrenia · Schizo Affective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05746494 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: The State Social Paranoia Scale (SSPS) — 9.72; 3.90 The change score of SSPS (pre - post) — p=0.023
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tDCS (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas at Dallas
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The State Social Paranoia Scale (SSPS) |
9.72; 3.90 | 0.023 sig |
| PRIMARY Ecological Momentary Assessment (EMA)-Based Paranoia |
3.78; 3.61; 3.96 | 0.042 sig |
| PRIMARY Birchwood Social Functioning Scale (SFS) |
114.21; 114.59 | 0.980 |
| PRIMARY Ecological Momentary Assessment (EMA)-Based Social Functioning |
0.97; 0.91; 0.92; 3.74; 4.08; 3.71 | 0.010 sig |
| SECONDARY The Trustworthiness Task |
0.07; -0.18 | 0.064 |
| SECONDARY The Scrambled-sentences Task (SST) |
0.46; 0.49 | 0.306 |
| SECONDARY The Ambiguous Intentions Hostility Questionnaire (AIHQ) |
8.28; 8.89; 2.09; 2.35; 1.75; 1.78 | 0.041 sig |
| SECONDARY The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS) |
9.42; 11.30 | 0.019 sig |
Summary
The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.
Eligibility Criteria
Inclusion Criteria
- Age = 18-64
- Diagnosed with schizophrenia or schizoaffective disorder
- Having current (in the past week) or recent (in the past month) paranoia
Exclusion Criteria
- Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ < 70
- Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)
- Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment
- History of electroconvulsive therapy
- Lack of proficiency in English
- Substance use disorder not in remission in the past 6 months
- Any implanted devices such as pace maker, neurostimulator
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT05746494). 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.