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40 Hz Visual Stimulation as an Intervention in Schizophrenia

NCT06907420 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

  • Negative Symptoms in Schizophrenia
  • Schizophrenia Disorders
  • Schizoaffective Disorder

Interventions

DEVICE

Visual 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.

Sponsors & Collaborators

  • Technical University of Munich

    lead OTHER

Principal Investigators

  • Ulrike Vogelmann, MD · TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2025-06-30
Completion
2025-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907420 on ClinicalTrials.gov