Treatment of Negative Symptoms and Schizophrenia (STICCS)

University Hospital Center (CHU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Schizophrenia

Treatments: Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02204787

9257

Details and patient eligibility

About

The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique, tDCS (transcranial direct current stimulation) used as a complementary treatment on negative symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social functioning.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  • Schizophrenia with prominent negative symptoms

• Exclusion Criteria:

  • other psychiatric or neurological diseases
  • specific tDCS limitations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

active tDCS

Experimental group

Description:

Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.

Treatment:

Device: transcranial direct current stimulation

Sham tDCS

Sham Comparator group

Description:

Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a sham stimulation during 20 minutes. Initial stimulation followed by turning off the device as to ensure blinding.

Treatment:

Device: transcranial direct current stimulation