Schizophrenia
Conditions
Keywords
Schizophrenia, Photoneuromodulation, Neuromodulation
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.
Interventions
DEVICEPhotoneuromodulation
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
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Subcale of PANSS | Weeks 0, 2 and 4 | Continuos measure (score changes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in WHOQOL | Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12] | Continuous measure (score changes). |
| Changes in Brief Negative Symptom Scale (BNSS) | Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12] | Continuous measure (score changes). |
| Changes in Calgary | Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12] | Continuous measure (score changes). |
| Changes in PANSS | Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12] | Continuous measure (score changes). |
| Changes in SANS | Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12] | Continuous measure (score changes). |
| Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA) | Time Frame: Weeks 0, 2, 4] | Continuous measure (score changes). |
| Changes in SOFAS | Time Frame: Weeks 0,1, 2, 3, 4, 6, 12] | Continuous measure (score changes). |
Countries
Brazil
Outcome results
None listed