A Double-blinded, Randomized Placebo-controlled Trial of 40 Hz Light Neurostimulation Therapy for Patients With Depression

What this Trial Is About

Researchers are investigating the antidepressant effects of 40 Hz light stimulation in adults with Major Depressive Disorder (MDD). This study builds on findings from Alzheimer's disease research, where 40 Hz flickering light therapy showed promise in halting disease progression and improving cognition. The trial aims to explore whether this non-invasive neurostimulation can similarly benefit patients with depression by inducing neuroplasticity and reducing neuroinflammation. Participants will use a Neurostimulation System (NSS) device at home for one hour daily over six weeks. The device delivers either a 40 Hz invisible spectral flicker (active setting) or continuous non-flickering white light (sham setting) in a double-blinded, randomized placebo-controlled design. After the six-week treatment period, there is a two-week follow-up to monitor ongoing effects. During the study, participants will undergo assessments at multiple timepoints including baseline, weeks 1, 3, 6, and 8. These evaluations include depression severity rating using the Hamilton Depression Rating sub-scale (HAM-D6), cognitive tests such as facial expression recognition and memory assessments, sleep quality monitoring, and quality of life questionnaires. Researchers will also analyze EEG data to explore brain activity changes related to treatment. Medication and psychotherapy regimens should remain stable throughout the study period.

40 Hz Light Neurostimulation for Patients With Depression (FELIX)