Schizophrenia Treatment With Photoneuromodulation

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05339347
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: Photoneuromodulation	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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 (Participant, Care Provider, 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.
• Primary Purpose: Treatment
• Official Title: A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.
• Actual Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in Subcale of PANSS [Weeks 0, 2 and 4]

   Continuos measure (score changes)

Secondary Outcome Measures

1. Changes in PANSS [Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]]

   Continuous measure (score changes).

2. Changes in WHOQOL [Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]]

   Continuous measure (score changes).

3. Changes in Brief Negative Symptom Scale (BNSS) [Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]]

   Continuous measure (score changes).

4. Changes in Calgary [Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]]

   Continuous measure (score changes).

5. Changes in SOFAS [Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]]

   Continuous measure (score changes).

6. Changes in SANS [Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]]

   Continuous measure (score changes).

7. Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA) [Time Frame: Weeks 0, 2, 4]]

   Continuous measure (score changes).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sao Paulo	Sao Paulo	SP	Brazil

Sponsors and Collaborators

• University of Sao Paulo

Investigators

• Principal Investigator: Leandro Valiengo, PhD, Study Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Leandro Valiengo, Medical Assistance, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT05339347
• Other Study ID Numbers: 4.545.487
• First Posted: Apr 21, 2022
• Last Update Posted: Apr 21, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Leandro Valiengo, Medical Assistance, University of Sao Paulo: Schizophrenia; Photoneuromodulation; Neuromodulation
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Apr 21, 2022