Schizophrenia Treatment With Photoneuromodulation

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Device: Photoneuromodulation

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil
      • University of Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients between 18 and 55 years
• Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID (Structured Clinical Interview for DSMIV), which will be applied by a psychiatrist, will be included.
• Minimum score of 20 points in the sum of negative PANSS
• Stable antipsychotic medications
• There is a need for at least one trial with at least one antipsychotic in adequate dose and time to enter the study.

Exclusion Criteria:

• Unstable or uncontrolled clinical diseases,
• Psychiatric comorbidities,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: Active Photoneuromodulation; Active stimulation with light fields as described in the intervention	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
Sham Comparator: Sham Comparator: Sham Photoneuromodulation; The blinding will be done with sham light, which consists of fields that do not reproduce light, but which have the same size and thickness as the true one.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Subcale of PANSS	Continuos measure (score changes)	Weeks 0, 2 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in PANSS	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in WHOQOL	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in Brief Negative Symptom Scale (BNSS)	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in Calgary	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in SOFAS	Continuous measure (score changes).	Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]
Changes in SANS	Continuous measure (score changes).	Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)	Continuous measure (score changes).	Time Frame: Weeks 0, 2, 4]

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Leandro Valiengo, PhD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Schizophrenia; Neuromodulation; Photoneuromodulation
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 4.545.487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No