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Evaluation of the Efficacy of Transcranial Direct Current Stimulation in the Treatment of Cognitive Symptomatology in the Early Stages of Psychosis

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 - tDCS: Transcranial Direct Current Stimulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2t3hfv
Enrollment
Unknown
Registered
2018-07-17
Start date
2018-07-16
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Intervention: tDCS, a non-invasive brain stimulation technique that involves the passage of a small current through the scalp and skull to modulate brain activity. The electric current will be deliver
and 35 to 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 ms
Device
E02.331

Sponsors

Universidade Federal de Sao Paulo - UNIFESP
Lead Sponsor
Universidade Federal de Sao Paulo - UNIFESP
Collaborator

Eligibility

Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Subjects of both genders, 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 - 5th edition (SCID-5); aged 18-60 years; minimum of 4 years of education; Intelligent Quotient (IQ) from low average to higher scores (IQ>70); and the subjects should be receiving stable doses of antipsychotics for at least four weeks (antipsychotic dose stability criterion).

Exclusion criteria

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) use of drugs that affect cognitive performance such as benzodiazepines and anticholinergic agents; (5) current diagnosis of substance abuse; (6) history of substance dependence in the last 6 months, except nicotine addiction; (7) current diagnosis of another Axis I condition, confirmed through SCID-5.

Design outcomes

Primary

MeasureTime frame
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.—

Secondary

MeasureTime frame
The secondary outcomes will be the positive and negative symptoms.—

Countries

Brazil

Contacts

Public ContactThais Rabanea de Souza

Universidade Federal de Sao Paulo - UNIFESP

thais.rabanea@unifesp.br+55-011-55764845

Outcome results

None listed

Source: REBEC (via WHO ICTRP)