Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels

NCT ID: NCT02652832

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Depression Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Depression Electroconvulsive therapy

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

Group Type ACTIVE_COMPARATOR

non invasive brain stimulation

Intervention Type DEVICE

non invasive brain stimulation

Depression active repetitive transcranial magnetic 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

Group Type ACTIVE_COMPARATOR

non invasive brain stimulation

Intervention Type DEVICE

non invasive brain stimulation

Depression sham repetitive transcranial magnetic 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

Group Type SHAM_COMPARATOR

non invasive brain stimulation

Intervention Type DEVICE

non invasive brain stimulation

Schizophrenia active transcranial magnetic stimulati

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

Group Type ACTIVE_COMPARATOR

non invasive brain stimulation

Intervention Type DEVICE

non invasive brain stimulation

Schizophrenia sham transcranial magnetic 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

Group Type SHAM_COMPARATOR

non invasive brain stimulation

Intervention Type DEVICE

non invasive brain stimulation

Schizophrenia active transcranial Direct Current 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

Group Type ACTIVE_COMPARATOR

non invasive brain stimulation

Intervention Type DEVICE

non invasive brain stimulation

Schizophrenia sham transcranial Direct Current 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

Group Type SHAM_COMPARATOR

non invasive brain stimulation

Intervention Type DEVICE

non invasive brain stimulation

Healthy volunteers

80 healthy volunteers receiving no stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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non invasive brain stimulation

non invasive brain stimulation

Intervention Type DEVICE

Other Intervention Names

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rTMS tDCS ECT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jerome brunelin, PhD

Role: STUDY_DIRECTOR

CH le vinatier

Locations

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Hopital Le vinatier

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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lydie sartelet

Role: CONTACT

+33437915531

Facility Contacts

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emmanuel poulet, MD, PhD

Role: primary

33437915565

Other Identifiers

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CSR B04

Identifier Type: -

Identifier Source: org_study_id

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