Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels (Plasti-Stim)

Hôpital le Vinatier

Status: Unknown

Conditions: Schizophrenia; Depression

Treatments: Device: non invasive brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02652832

CSR B04

Details and patient eligibility

About

The aim of this study is to investigate the effects of non invasive brain stimulation - NIBS - techniques (Electroconvulsivotherapy - ECT, transcranial Direct Current Stimulation - tDCS, repetitive transcranial magnetic stimulation - rTMS) on serum Brain Derived Neurotrophic factor (BDNF) levels in patients with depression and schizophrenia. Four blood samples will be collected in each participants, one before the NIBS sessions, and 3 after the completion of NIBS protocols: one immediately after the end of the NIBS sessions, a second one week after and a last one month after. Two blood samples separated by one month will also be collected in a a group of healthy volunteers.

Full description

The hypothesis is that NIBS will modulate BDNF levels and that the modification in serum BDNF levels will be correlated with clinical improvements in the sample of patients.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• in the depression group: DSM IV criteria of MDD; HDRS17> 22; stage 2 of resistance; received rTMS or ECT
• in the schizophrenia group DSM IV criteria of schizophrenia; pharmaco-resistance of symptoms (either negative symptoms or auditory verbal hallucination); received rTMS or tDCS
• in the healthy volunteers group : to not have axis I of DSM IV diagnosis; no siblings with axis I DSM IV diagnosis

Exclusion criteria

• less than 18 years old
• pregnancy
• received benzodiazepine

In the depression and schizophrenia group:

• bipolar disorder
• other axis I of DSM IV diagnosis (excluding for Tobacco use disorder)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 8 patient groups

Depression Electroconvulsive therapy

Active Comparator group

Description:

40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy

Treatment:

Device: non invasive brain stimulation

Depression active repetitive transcranial magnetic stimulation

Active Comparator group

Description:

40 patients with major depression receiving a mean 4 weeks of 1 Hz repetitive transcranial magnetic stimulation applied over the right dorsolateral prefrontal cortex - DLPFC

Treatment:

Device: non invasive brain stimulation

Depression sham repetitive transcranial magnetic stimulation

Sham Comparator group

Description:

40 patients with major depression receiving a mean 4 weeks of sham 1 Hz repetitive transcranial magnetic stimulation applied over the right dorsolateral prefrontal cortex - DLPFC

Treatment:

Device: non invasive brain stimulation

Schizophrenia active transcranial magnetic stimulati

Active Comparator group

Description:

40 patients with schizophrenia and predominant negative symptoms receiving 20 sessions of intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC

Treatment:

Device: non invasive brain stimulation

Schizophrenia sham transcranial magnetic stimulation

Sham Comparator group

Description:

patients with schizophrenia and predominant negative symptoms receiving 20 sessions of sham intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC

Treatment:

Device: non invasive brain stimulation

Schizophrenia active transcranial Direct Current Stimulation

Active Comparator group

Description:

40 patients with schizophrenia and auditory verbal hallucinations receiving 10 sessions of transcranial Direct current stimulation (tDCS) applied with the anode over the left dorsolateral prefrontal cortex - DLPFC- and the cathode over the left temporoparietal junction

Treatment:

Device: non invasive brain stimulation

Schizophrenia sham transcranial Direct Current Stimulation

Sham Comparator group

Description:

40 patients with schizophrenia and auditory verbal hallucinations receiving 10 sessions of sham transcranial Direct current stimulation (tDCS) applied with the anode over the left dorsolateral prefrontal cortex - DLPFC- and the cathode over the left temporoparietal junction

Treatment:

Device: non invasive brain stimulation

Healthy volunteers

No Intervention group

Description:

80 healthy volunteers receiving no stimulation