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

July 31, 2018 updated by: Hôpital le Vinatier
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69677
        • Recruiting
        • Hopital Le Vinatier
        • Principal Investigator:
          • Emmanuel Poulet, MD, PhD
        • Contact:
          • emmanuel poulet, MD, PhD
          • Phone Number: 33437915565
        • Sub-Investigator:
          • frederic haesebaert, md, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Depression Electroconvulsive therapy
40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy
Device: non invasive brain stimulation
non invasive brain stimulation
Other Names:
  • ECT
  • rTMS
  • tDCS
Active Comparator: 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
Device: non invasive brain stimulation
non invasive brain stimulation
Other Names:
  • ECT
  • rTMS
  • tDCS
Sham Comparator: 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
Device: non invasive brain stimulation
non invasive brain stimulation
Other Names:
  • ECT
  • rTMS
  • tDCS
Active Comparator: 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
Device: non invasive brain stimulation
non invasive brain stimulation
Other Names:
  • ECT
  • rTMS
  • tDCS
Sham Comparator: 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
Device: non invasive brain stimulation
non invasive brain stimulation
Other Names:
  • ECT
  • rTMS
  • tDCS
Active Comparator: 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
Device: non invasive brain stimulation
non invasive brain stimulation
Other Names:
  • ECT
  • rTMS
  • tDCS
Sham Comparator: 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
Device: non invasive brain stimulation
non invasive brain stimulation
Other Names:
  • ECT
  • rTMS
  • tDCS
No Intervention: Healthy volunteers
80 healthy volunteers receiving no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum BDNF levels
Time Frame: from baseline to one month
from baseline to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Investigators

  • Study Director: jerome brunelin, PhD, CH Le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2010

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

January 8, 2016

First Posted (Estimate)

January 12, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSR B04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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