RecruitingNot ApplicableNCT06907420

40 Hz Visual Stimulation as an Intervention in Schizophrenia

Effects of Multi-Session 40 Hz Visual Stimulation on Neuronal and Psychiatric Outcomes in Schizophrenia


Sponsor

Technical University of Munich

Enrollment

20 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Medical diagnosis of schizophrenia (F20) or schizoaffective disorder (F25)

Exclusion Criteria6

  • 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

Interventions

DEVICEVisual stimulation

40 Hz visual stimulation will be delivered at the same time of day over 5 consecutive days. Participants will lay down while wearing the customized sleep mask with inbuilt red LEDs flickering at 40 Hz linked to a microcontroller. Participants will be asked to keep their eyes closed and encouraged to fall asleep for the full stimulation duration of 60 minutes.


Locations(1)

Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy

Munich, Bavaria, Germany

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NCT06907420


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