40 Hz Visual Stimulation as an Intervention in Schizophrenia
Recruiting · NCT06907420 · Interventional (participants receive a specific treatment) · Lead sponsor: Technical University of Munich
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
In schizophrenia, an abnormal reduction in neuronal gamma oscillations (30-100 Hz) is associated with negative symptoms such as cognitive dysfunction. The literature suggests that rescuing gamma oscillations through non-invasive brain stimulation may be an accessible and safe add-on strategy to mitigate negative symptoms. Here, a stimulation protocol based on gamma visual stimulation will be tested. This pilot study will follow an uncontrolled clinical trial design: A minimum of ten patients diagnosed with schizophrenia or a schizoaffective disorder and predominant negative symptoms will be recruited at Klinikum rechts der Isar. They will undergo a multisession stimulation protocol, consisting of one hour of 40 Hz visual stimulation per day over five consecutive days, during which they will be encouraged to fall asleep. An equal number of patients will be recruited for a treatment-as-usual group without intervention. Pre- and post-assessments will include EEG, a cognitive test battery (THINC-IT), a mood scale (PANAS), and a schizophrenia symptom scale (PANSS). This study's results will inform on the feasibility of gamma visual stimulation as a potential add-on intervention in schizophrenia.
Who can take part
Inclusion criteria
- Medical diagnosis of schizophrenia (F20) or schizoaffective disorder (F25)
Exclusion criteria
- Age \< 18 years
- Any history of seizures
- Acute suicidality assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS; Brent et al., 2008)
- Any other relevant axis 1 disorder
- Red-green colour blindness or current ocular disease
- Alcohol, cannabis, or illicit drug addiction within the last 3 months
Where it is running
1 location listed.
- Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy - Munich, Bavaria, Germany