Schizophrenia Treatment With Photoneuromodulation

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: Photoneuromodulation


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Active Photoneuromodulation<br>Active stimulation with light fields as described in the intervention | Device: Photoneuromodulation<br>* 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<br>|
| Sham Comparator: Sham Comparator: Sham Photoneuromodulation<br>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<br>* 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<br>|

What is the study measuring?
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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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Photoneuromodulation, Neuromodulation