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

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ClinicalTrials.gov Identifier: NCT03071484
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Acioly Luiz Tavares de Lacerda, Instituto Bairral de Psiquiatria

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Schizophrenia Device: Transcranial Direct Current Stimulation Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 19, 2018
Estimated Primary Completion Date : March 17, 2019
Estimated Study Completion Date : August 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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 Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. MCCB™ MATRICS™ (Measurement and Treatment Research to Improve Cognition in Schizophrenia) Consensus Cognitive Battery [ Time Frame: 3 months follow up ]
    A consensus cognitive battery for measuring cognition in schizophrenia,


Secondary Outcome Measures :
  1. Positive and Negative Symptoms Scale (PANSS) [ Time Frame: 3 months follow up ]
    Positive and Negative Symptoms Scale (PANSS)



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071484


Contacts
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Contact: Lacerda, MD, PhD +55 19 38639438 acioly@institutosinapse.org

Locations
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Brazil
Laboratory of Interdisciplinary Clinical Neurosciences, Department of Psychiatry, Federal University of Sao Paulo Recruiting
Sao Paulo, Brazil, 04039-032
Contact: Acioly LT Lacerda, MD, PhD    55 19 3251-4397    acioly@institutosinapse.org   
Contact: Thaís Rabanea-Souza, MSc    55 11 4612-9513    thais.rabanea@unifesp.br   
Sponsors and Collaborators
Instituto Bairral de Psiquiatria
Federal University of São Paulo
Investigators
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Principal Investigator: Rabanea-Souza, MsC Federal University of São Paulo

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Responsible Party: Acioly Luiz Tavares de Lacerda, PhD, Instituto Bairral de Psiquiatria
ClinicalTrials.gov Identifier: NCT03071484     History of Changes
Other Study ID Numbers: 2155/08
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Acioly Luiz Tavares de Lacerda, Instituto Bairral de Psiquiatria:
Early Stages of Psychosis
Schizophrenia
Transcranial Direct Current Stimulation
Cognitive Symptomatology
Double-blind Randomized Controlled Trial

Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders