Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels

NCT02652832 | Terminated DMC

• 1 other identifier: CSR B04
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• serum BDNF levels

  from baseline to one month

Study Arms (8)

Depression Electroconvulsive therapy

ACTIVE COMPARATOR

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

Device: non invasive brain stimulation

Depression active repetitive transcranial magnetic stimulation

ACTIVE COMPARATOR

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

Device: non invasive brain stimulation

Depression sham repetitive transcranial magnetic stimulation

SHAM COMPARATOR

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

Device: non invasive brain stimulation

Schizophrenia active transcranial magnetic stimulati

ACTIVE COMPARATOR

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

Device: non invasive brain stimulation

Schizophrenia sham transcranial magnetic stimulation

SHAM COMPARATOR

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

Device: non invasive brain stimulation

Schizophrenia active transcranial Direct Current Stimulation

ACTIVE COMPARATOR

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

Device: non invasive brain stimulation

Schizophrenia sham transcranial Direct Current Stimulation

SHAM COMPARATOR

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

Device: non invasive brain stimulation

Healthy volunteers

NO INTERVENTION

80 healthy volunteers receiving no stimulation

Interventions

non invasive brain stimulation DEVICE

non invasive brain stimulation

Also known as: rTMS, tDCS, ECT

Depression Electroconvulsive therapy; Depression active repetitive transcranial magnetic stimulation; Depression sham repetitive transcranial magnetic stimulation; Schizophrenia active transcranial Direct Current Stimulation; Schizophrenia active transcranial magnetic stimulati; Schizophrenia sham transcranial Direct Current Stimulation; Schizophrenia sham transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Le vinatier

Bron, 69677, France

Location

MeSH Terms

Conditions

Depression; Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• jerome brunelin, PhD

  CH le vinatier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: January 12, 2016
• Study Start: December 1, 2010
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (1)