An open-source, high-performance tool for automated sleep staging.
Raphael Vallat, Matthew P Walker
https://pubmed.ncbi.nlm.nih.gov/34648426Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06907420
Effects of Multi-Session 40 Hz Visual Stimulation on Neuronal and Psychiatric Outcomes in Schizophrenia
Led by Technical University of Munich · Updated on 2025-04-02
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of 40 Hz visual stimulation as an add-on method to help improve negative symptoms, including cognitive difficulties, in people with schizophrenia or schizoaffective disorder. The study is a pilot trial comparing a group receiving visual stimulation with a group receiving their usual treatment. The goal is to assess whether this non-invasive brain stimulation method can influence brain activity patterns linked to symptoms and improve mood and cognition. Participants in the experimental group will undergo one hour of 40 Hz visual stimulation each day for five consecutive days using a customized sleep mask with red LEDs flickering at 40 Hz. They will lie down with their eyes closed and be encouraged to fall asleep during the stimulation. The control group will continue their usual treatment without additional intervention. The study includes pre- and post-assessments conducted before the first and after the last stimulation session. EEG brain activity will be recorded during the first and last stimulation sessions. Throughout the study, participants will complete mood and cognitive tests, and trained physicians will assess psychiatric symptoms. The visual stimulation sessions will be monitored for any side effects by asking participants about undesired effects after each session. EEG data will be analyzed to measure brain responses to the stimulation. The total study duration includes multiple assessment sessions before and after the stimulation week, providing detailed information on brain and symptom changes related to the intervention.
CONDITIONS
Brief Title
40 Hz Visual Stimulation as an Intervention in Schizophrenia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Medical diagnosis of schizophrenia (F20) or schizoaffective disorder (F25)
You will not qualify if you...
- Age less than 18 years
- Any history of seizures
- Acute suicidality assessed with the Columbia-Suicide Severity Rating Scale (C-SSRS)
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessments
Duration - 1 to 5 days before intervention
Participants complete pre-tests including mood and cognition scales and psychiatric symptom assessment before starting the intervention.
1 visit (in-person)
Implementation
Duration - 5 consecutive days
Participants undergo 1 hour of 40 Hz visual stimulation daily over 5 consecutive days while wearing a customized sleep mask. EEG is recorded during the first and last stimulation sessions.
5 daily visits (in-person)
Post-Intervention Assessments
Duration - Up to 3 days
Participants complete mood and cognition scales immediately after the last stimulation and psychiatric symptom assessment within three days following the intervention.
1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy
Munich, Bavaria, Germany, 81675
Actively Recruiting
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Research Team
U
Ulrike Vogelmann, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The positive and negative syndrome scale (PANSS) for schizophrenia.
S R Kay, A Fiszbein, L A Opler
https://pubmed.ncbi.nlm.nih.gov/3616518Development and validation of brief measures of positive and negative affect: the PANAS scales.
D Watson, L A Clark, A Tellegen
https://pubmed.ncbi.nlm.nih.gov/3397865THINC-Integrated Tool (THINC-it): A Brief Measurement of Changes in Cognitive Functioning and Its Correlation with the Life Quality of Patients with Schizophrenia and Related Disorders-A Pilot Study.
Joanna K Szmyd, Karol Lewczuk, Kayla M Teopiz...
https://pubmed.ncbi.nlm.nih.gov/36979199Stability, reliability, and validity of the THINC-it screening tool for cognitive impairment in depression: A psychometric exploration in healthy volunteers.
John E Harrison, Harry Barry, Bernhard T Baune...
https://pubmed.ncbi.nlm.nih.gov/3008829840 Hz visual stimulation during sleep evokes neuronal gamma activity in NREM and REM stages.
Laura Hainke, James Dowsett, Manuel Spitschan...
https://pubmed.ncbi.nlm.nih.gov/39700417