Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels

Not Applicable

• Conditions: Depression; Schizophrenia
• Interventions: Device: non invasive brain stimulation

• Registration Number: NCT02652832
• Lead Sponsor: Hôpital le Vinatier

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Schizophrenia active transcranial magnetic stimulati	non invasive brain stimulation	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
Depression Electroconvulsive therapy	non invasive brain stimulation	40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy
Depression sham repetitive transcranial magnetic stimulation	non invasive brain stimulation	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
Schizophrenia sham transcranial magnetic stimulation	non invasive brain stimulation	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
Schizophrenia active transcranial Direct Current Stimulation	non invasive brain stimulation	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
Schizophrenia sham transcranial Direct Current Stimulation	non invasive brain stimulation	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
Depression active repetitive transcranial magnetic stimulation	non invasive brain stimulation	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

Primary Outcome Measures

Name	Time	Method
serum BDNF levels	from baseline to one month

Trial Locations

Locations (1)

Hopital Le vinatier; 🇫🇷 Bron, France