NCT05339347

Schizophrenia Treatment With Photoneuromodulation

A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Abstract: Randomized clinical trial that aims to see the efficacy of photoneuromodulation for the treatment of negative symptoms of schizophrenia in patients refractory to transcranial direct current stimulation. In this group of 30 refractory volunteers, magnetic resonance spectroscopy will be performed before and after photoneuromodulation in a cross-over design. Objectives: Effectiveness of photoneuromodulation in patients with schizophrenia. . Analysis of glutamate, Gaba and lactate in spectroscopy before and after stimulation (secondary) Sample: 30 volunteers with negative symptoms of schizophrenia refractory to treatment. Method: clinical trial, cross-over randomized, double-blind, sham-controlled. PANSS negative symptoms subscale evaluation before and after the 10 photoneuromodulation sessions. Participants who are in the active group after the 10 photoneuromodulation sessions will go to the sham group and vice versa. They will perform magnetic resonance spectroscopy before the beginning, after the 10 sessions and again after the inversion of the groups (3 resonances per volunteer). The study will be a cross-over: half of participants will start at sham group and the other half at active group and invert groups after 10th day of stimulation.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	Photoneuromodulation	Treatments were administered daily for a period of 2 weeks (10 sessions) with a Light-Aid (Bright Photomedicine, SP, Brazil), continuous wave, 300 LED wavelength 850 nm) or with a placebo probe of the same appearance and display. The irradiation parameters created will be based on the disease, pain intensity and skin phototype. Each session has from 10 to 15 min, depending on skin phototype

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2022-04-21
• Last updated: 2025-09-29

Locations

1 site across 1 country: Brazil