N/A
N=6
Feasibility Electrical Stimulation Study for Visual Hallucinations
Schizophrenia · Schizoaffective Disorder · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04870710 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Steady State Visual Evoked Potential (ssVEP) — 1.725; 1.160; 1.180; 1.005 microvolts — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial electrical stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady State Visual Evoked Potential (ssVEP) |
1.725; 1.160; 1.180; 1.005; 1.160; 2.560 | — |
| PRIMARY Steady State Visual Evoked Potential (ssVEP) |
1.725; 1.160; 1.180; 1.005; 1.160; 2.560 | — |
| PRIMARY Positive and Negative Syndrome Scale (PANSS) |
49.50; 59.50; 44.00; 56.50; 50.00; 47.50 | — |
| PRIMARY Positive and Negative Syndrome Scale (PANSS) |
49.50; 59.50; 44.00; 56.50; 50.00; 47.50 | — |
| PRIMARY Biological Motion |
63.33; 60.00; 68.33; 71.67; 69.17; 60.00 | — |
| PRIMARY Biological Motion |
63.33; 60.00; 68.33; 71.67; 69.17; 60.00 | — |
| SECONDARY International Affective Picture System (IAPS) Task |
6.525; 5.751; 3.25 | — |
| SECONDARY International Affective Picture System (IAPS) Task |
6.525; 5.751; 3.25 | — |
| SECONDARY Velocity Discrimination |
0.181; 0.2020; 0.188; 0.1600; 0.188; 0.17 | — |
| SECONDARY Velocity Discrimination |
0.181; 0.2020; 0.188; 0.1600; 0.188; 0.17 | — |
| SECONDARY Visual Spatial Working Memory |
5.925; 5.000; 5.250; 4.700; 6.475; 5.250 | — |
| SECONDARY Visual Spatial Working Memory |
5.925; 5.000; 5.250; 4.700; 6.475; 5.250 | — |
| SECONDARY Global Assessment of Function (GAF) |
70.00; 65.00; 68.50; 65.00; 63.00; 68.00 | — |
| SECONDARY Global Assessment of Function (GAF) |
70.00; 65.00; 68.50; 65.00; 63.00; 68.00 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) |
6.00; 5.50; 3.50; 4.00; 6.00; 2.50 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) |
6.00; 5.50; 3.50; 4.00; 6.00; 2.50 | — |
Summary
The visual system has increasingly been recognized as an important site of injury in patients with schizophrenia and other psychoses. Visual system alterations manifest as visual perceptual aberrations, deficits in visual processing, and visual hallucinations. These visual symptoms are associated with worse symptoms, poorer outcome and resistance to treatment. A recent study using brain lesion mapping of visual hallucinations and identified a causal location in the part of the brain that processes visual information (visual cortex). The association between visual cortex activation and visual hallucinations suggests that this region could be targeted using noninvasive brain stimulation. Two case studies have found that brain stimulation to the visual cortex improved visual hallucinations in treatment resistant patients with psychosis. While promising it is unclear whether these symptom reductions resulted from activity changes in the visual cortex or not. Here we aim to answer the question whether noninvasive brain stimulation when optimally targeted to the visual cortex can improve brain activity, visual processing and visual hallucinations. The knowledge gained from this study will contribute to the field of vision by providing a marker for clinical response and by personalizing treatment for patients with psychosis suffering from visual symptoms. This grant will allow us to set the foundation for a larger more targeted study utilizing noninvasive brain stimulation to improve visual symptoms in patients with psychosis.
Eligibility Criteria
Inclusion Criteria
- meet diagnostic criteria for schizophrenia, schizoaffective disorder, or psychotic bipolar disorder as verified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR) and consensus clinical diagnosis;
- had no changes to relevant anti-psychotic medications for a period of 1 month prior to participation;
- had a sufficient level of English to allow participation.
Exclusion Criteria
- pregnant or breastfeeding women;
- Intelligence quotient <60
- any major medical or neurologic
- diagnosis of substance abuse positive urine drug screen
- history of moderate-to-severe visual impairment secondary to glaucoma, cataract or macular degeneration
- serious medical illness or instability requiring hospitalization within the next year
- relevant skin allergies; metallic or electronic implants (e.g. pacemakers, brain stimulators).
Data sourced from ClinicalTrials.gov (NCT04870710). 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.