Schizophrenia Treatment With Photoneuromodulation

NCT05339347 | Completed Phase 2

• 1 other identifier: 4.545.487
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Schizophrenia; Photoneuromodulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Changes in Subcale of PANSS

  Continuos measure (score changes)

  Weeks 0, 2 and 4

Secondary Outcomes (7)

• Changes in PANSS

  Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

• Changes in WHOQOL

  Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

• Changes in Brief Negative Symptom Scale (BNSS)

  Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

• Changes in Calgary

  Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]

• Changes in SOFAS

  Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]

Study Arms (2)

Active Comparator: Active Photoneuromodulation

ACTIVE COMPARATOR

Active stimulation with light fields as described in the intervention

Device: Photoneuromodulation

Sham Comparator: Sham Photoneuromodulation

SHAM COMPARATOR

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

Interventions

Photoneuromodulation DEVICE

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

Active Comparator: Active Photoneuromodulation; Sham Comparator: Sham Photoneuromodulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unstable or uncontrolled clinical diseases,
• Psychiatric comorbidities,

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Leandro Valiengo, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: We have two identical devices (a and b), that are equal in all aspects, but one of them is sham (does not product infrared (IR) light). As IR light is invisible for human eyes, neither the applicant of the procedure neither the participant will know if it is active or sham. All the participants had a code after randomization that does the allocation to sham or active. The machine (a or b) was chosen for an external researcher that has no contact with the team of the research.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Assistance

Model Details: For the sham, the tip has LED light similar to the real one, but without generating the light field. The treatments will be administered in two sessions (active/sham) with a Light-Aid (Bright Photomedicine, SP, Brazil), continuous wave, 300 LEDs, wavelength of 850 nm). The irradiation parameters created will be based on the skin phototype according to the Fitzpatrick Scale. The tip will be positioned in the prefrontal cortex (corresponding to F3 and F4 according to the 10-20 EEG system). This arrangement is commonly known as 'Bifrontal'. In each application, power densities between 45-50 mW/cm², frequency of 10 Hz, and total time of 10 to 15 minutes per session will be used. The tip used has a size equivalent to 70cm² each side.

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Study Start: August 1, 2021
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)