Clinical trial NCT05339347: Schizophrenia Treatment With Photoneuromodulation
Official title: A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Photoneuromodulation
Neuromodulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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,

Primary outcomes:
measure: Changes in Subcale of PANSS
timeFrame: Weeks 0, 2 and 4
Secondary outcomes:
measure: Changes in PANSS
timeFrame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
measure: Changes in WHOQOL
timeFrame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
measure: Changes in Brief Negative Symptom Scale (BNSS)
timeFrame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
measure: Changes in Calgary
timeFrame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
measure: Changes in SOFAS
timeFrame: Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]
measure: Changes in SANS
timeFrame: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
measure: Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)
timeFrame: Time Frame: Weeks 0, 2, 4]
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: Study Principal Investigator
name: Leandro Valiengo, PhD
role: PRINCIPAL_INVESTIGATOR
References: