Schizophrenia Treatment With Photoneuromodulation
A Sham-controlled Crossover Study Using Photoneuromodulation to Treatment the Negative Symptoms of Schizophrenia.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Leandro Valinego, PhD
- Numéro de téléphone: +55 11 2661-8159
- E-mail: pesquisa.esquizofrenia@gmail.com
Lieux d'étude
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SP
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Sao Paulo, SP, Brésil
- Recrutement
- University of Sao Paulo
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Chercheur principal:
- Leandro Valiengo, MD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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,
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Active Comparator: Active Photoneuromodulation
Active stimulation with light fields as described in the intervention
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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
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Comparateur factice: 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.
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in Subcale of PANSS
Délai: Weeks 0, 2 and 4
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Continuos measure (score changes)
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Weeks 0, 2 and 4
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in PANSS
Délai: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
|
Continuous measure (score changes).
|
Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
|
|
Changes in WHOQOL
Délai: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
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Continuous measure (score changes).
|
Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
|
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Changes in Brief Negative Symptom Scale (BNSS)
Délai: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
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Continuous measure (score changes).
|
Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
|
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Changes in Calgary
Délai: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
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Continuous measure (score changes).
|
Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
|
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Changes in SOFAS
Délai: Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]
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Continuous measure (score changes).
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Time Frame: Weeks 0,1, 2, 3, 4, 6, 12]
|
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Changes in SANS
Délai: Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
|
Continuous measure (score changes).
|
Time Frame: Weeks 0, 1, 2, 3, 4, 6, 12]
|
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Changes in parameters of spectroscopy (lactate, glutamate, glicine and GABA)
Délai: Time Frame: Weeks 0, 2, 4]
|
Continuous measure (score changes).
|
Time Frame: Weeks 0, 2, 4]
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Leandro Valiengo, PhD, Study Principal Investigator
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 4.545.487
Informations sur les médicaments et les dispositifs, documents d'étude
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