STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2022
• Main ID: NCT02744989
• Date of registration: 18/03/2016
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia STIM'ZO
• Scientific title: STIM'ZO : Examining tDCS as an add-on Treatment for Persistent Symptoms in Schizophrenia (SCH)
• Date of first enrolment: May 30, 2016
• Target sample size: 141
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02744989
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

France, Monaco

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of schizophrenia according to DSM 5.0 (Diagnostic and Statistical Manuel
5.0) criteria

2. Presence of symptoms despite the optimization of the antipsychotic dosage (based on
prescriber's judgment) for at least 6 weeks, i.e. a dosage increase cannot be
considered due to tolerability issues and/or is judged unlikely to bring sufficient
clinical improvement. This will be operationalized by a minimum Negative PANSS score
of 20 and at least one item scoring > 4; OR a minimum Positive PANSS score of 20 with
at least one item scoring > 4 (e.g. delusion or hallucination), indicating persistent
negative symptoms and/or persistent positive symptoms,

3. Patient under curatorship/guardianship or not

4. Age between 18 and 65 years old.

5. Covered by, or having the right to Social Security

6. Patient who understands the French language

7. Informed consent signed

Exclusion Criteria:

1. Other neuropsychiatric disorders (psychiatric history will be assessed using the MINI
6.0 (Mini International Neuropsychiatric Interview 6.0)) including bipolar disorders
and mood depression disorders - (NB: Patients with substance related and addictive
disorders will not be excluded from the study, but these data will be carefully
recorded).

2. Contraindications for tDCS (neurologic stimulator, pacemaker, cardiac defibrillator,
cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal
fluid derivation, metallic splinters in the eyes),

3. Increase in total composite PANSS score of at least 20% between screening and
enrollment visits

4. Women who are pregnant

5. Patients whose clinical condition requires in patient procedure under constraint



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Mental Disorders

Intervention(s)

Device: Neuroconn or Neuroelectric tDCS stimulator

Device: Sham tDCS

Primary Outcome(s)

Number of responders [Time Frame: Between baseline (day 0) and after 10-sessions of tDCS regimen (day 5)]

Secondary Outcome(s)

Calgary Depression Scale for Schizophrenia (CDSS) score [Time Frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session]

Auditory Hallucination Rating Scale (AHRS) score [Time Frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session]

Anatomical magnetic resonance imaging (MRI) [Time Frame: Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session]

Scale to assess Unawareness of Mental Disorder (SUMD) score [Time Frame: Baseline and 3 months after the last tDCS session]

Source monitoring test score [Time Frame: Baseline and day 5 (after 10-sessions of tDCS regimen)]

Total serum Brain-Derived-Neurotrophic Factor (BDNF) [Time Frame: Baseline]

Serum Brain-Derived-Neurotrophic Factor (BDNF) isoforms [Time Frame: Baseline]

Fargerström test score [Time Frame: Baseline, 1 month and 6 months after the last tDCS session]

Functional magnetic resonance imaging (MRI) [Time Frame: Baseline, day 5 (after 10-sessions of tDCS regimen) and 1 month after the last tDCS session]

Medication Adherence rating Scale (MARS) score [Time Frame: Baseline and 3 months after the last tDCS session]

Positive and Negative Syndrome Scale (PANSS) score [Time Frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session]

Brief Medication Questionnaire (BMQ) scores [Time Frame: Baseline and 3 months after the last tDCS session]

Clinical Global Impression (CGI) score [Time Frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session]

Psycho-Sensory hAllucinations Scale (PSAS) score [Time Frame: Baseline, day 5 (after 10-sessions of tDCS regimen), 1 month, 3 months and 6 months after the last tDCS session]

Self-evaluation of Negative Symptoms (SNS) score [Time Frame: Baseline, 1 month and 3 months after the last tDCS session]

Shortened Quality of Life questionnaire score [Time Frame: Baseline and 6 months after the last tDCS session]

Secondary ID(s)

69HCL14_0446

Source(s) of Monetary Support

Please refer to primary and secondary sponsors