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Efficacy of Transcranial Direct Current Stimulation in Treatment of Cognitive Deficits in Early Stages of Psychosis

15. februar 2020 opdateret af: Acioly Luiz Tavares de Lacerda, Instituto Bairral de Psiquiatria

Evaluation of the Efficacy of Transcranial Direct Current Stimulation in the Treatment of Cognitive Symptomatology in the Early Stages of Psychosis: Study Protocol of a Double-blind Randomized Controlled Trial

Background: Cognitive deficits are a core symptom of schizophrenia even at the early stages of psychosis. To date, there has been reliable evidence that cognitive deficits are associated with outcomes in schizophrenia and early treatment could help to reduce the prominent disabling cognitive symptomatology which most schizophrenia patients still experience persistently. Outcomes in studies of repetitive transcranial magnetic stimulation in schizophrenia patients suggest the possibility that application of transcranial direct-current stimulation (tDCS) with inhibitory stimulation over the left temporo-parietal cortex and excitatory stimulation over the left dorsolateral prefrontal cortex could affect positive and negative symptoms, respectively. Positive effects of tDCS have also been reported on cognitive symptoms. The present study protocol hypothesis is that the development and utilization of potentially effective neuroenhancement tools such as a non-invasive brain stimulation technique like tDCS for the treatment and rehabilitation of cognitive impairment in early stages of Schizophrenia may contribute to the elucidation of the nature of the complex and dynamic processes in the brain during the early stages of the disease, and may lead to a better outcome.

Objectives: The aim of the present study protocol is to evaluate the efficacy of tDCS in the treatment of cognitive symptomatology in the early stages of psychosis.

Methods: Sixty patients in the early stages of psychosis will be randomly allocated to receive 20 minutes of active 2-mA tDCS or sham stimulation once a day on 10 consecutive weekdays. The anode will be placed over the left dorsolateral prefrontal cortex and the cathode over the left temporo-parietal cortex. Neuropsychological and psychiatric assessments will be performed at the time of consent (baseline), at 1 and 3 months following the end of the intervention (maintenance effect).

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The design of the present study protocol is a double-blind placebo controlled randomised clinical trial.

After being randomly allocated, the experimental group will receive a 20 minutes of active 2-mA tDCS once a day on 10 consecutive weekdays. The control group will receive a sham stimulation (placebo), which chosen parameters consists in after 40 seconds of real stimulation (2 mA), only a small current pulse occurred every 550 msec (110 mA over 15 msec) through the remainder of the 20-minute period.

Neuropsychological and psychiatric assessments will be performed at the time of consent (baseline), and at 1 and 3 months following the end of the intervention (maintenance effect). The primary outcome will be cognitive function and the second outcomes will be the positive and negative symptoms. Outcome assessments will be performed by trial research staff. Primary and second outcomes assessors (neuropsychologists and psychiatrists) and patients will be blinded to randomized allocation after assignment to interventions.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien, 04039-032
        • Rekruttering
        • Laboratory of Interdisciplinary Clinical Neurosciences, Department of Psychiatry, Federal University of Sao Paulo
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

17 år til 60 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

The inclusion criteria include:

  1. subjects of both gender, diagnosed with schizophrenia in early stage psychosis (first five years of illness), confirmed through the Structured Interview of the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition (SCID-IV);
  2. aged 17-60 years;
  3. minimum of 4 years of schooling;
  4. Intelligent Quotient (IQ) from low average to higher scores (IQ>70);
  5. and the subjects should be receiving stable doses of antipsychotics for at least four weeks (antipsychotic dose stability criterion).

Exclusion Criteria:

  1. presence of a history of cranioencephalic trauma with loss of consciousness with a time greater than 5 minutes;
  2. history of central nervous system diseases that affect the brain;
  3. unstable clinical conditions;
  4. current diagnosis of substance abuse;
  5. history of substance dependence in the last 6 months, except nicotine addiction;
  6. current diagnosis of another Axis I condition, confirmed through SCID-IV.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Transcranial Direct Current Stimulation
After being randomly allocated, the experimental group will receive a 20 minutes of active 2-mA tDCS once a day on 10 consecutive weekdays.
Enhed: Transcranial Direct Current Stimulation
The tDCS is a non-invasive neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity.
Placebo komparator: Sham - tDCS
The control group will receive a sham stimulation, which chosen parameters consists in after 40 seconds of real stimulation (2 mA), only a small current pulse occurred every 550 msec (110 mA over 15 msec) through the remainder of the 20-minute period.
Enhed: Transcranial Direct Current Stimulation
The tDCS is a non-invasive neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MCCB™ MATRICS™ (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery
Tidsramme: 3 months follow up
A consensus cognitive battery for measuring cognition in schizophrenia,
3 months follow up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Positive and Negative Symptoms Scale (PANSS)
Tidsramme: 3 months follow up
Positive and Negative Symptoms Scale (PANSS)
3 months follow up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Instituto Bairral de Psiquiatria

Samarbejdspartnere

Federal University of São Paulo

Efterforskere

  • Ledende efterforsker: Rabanea-Souza, MsC, Federal University of Sao Paulo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. august 2020

Primær færdiggørelse (Forventet)

1. oktober 2020

Studieafslutning (Forventet)

1. august 2021

Datoer for studieregistrering

Først indsendt

13. februar 2017

Først indsendt, der opfyldte QC-kriterier

1. marts 2017

Først opslået (Faktiske)

7. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2155/08

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Transcranial Direct Current Stimulation

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