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Trial record 10 of 173 for:    Recruiting, Not yet recruiting, Available Studies | psychiatric disorder OR bipolar OR depression | Brain Stimulation

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

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ClinicalTrials.gov Identifier: NCT02652832
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Schizophrenia Device: non invasive brain stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
Actual Study Start Date : December 2010
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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:
  • rTMS
  • tDCS
  • ECT

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:
  • rTMS
  • tDCS
  • ECT

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:
  • rTMS
  • tDCS
  • ECT

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:
  • rTMS
  • tDCS
  • ECT

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:
  • rTMS
  • tDCS
  • ECT

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:
  • rTMS
  • tDCS
  • ECT

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:
  • rTMS
  • tDCS
  • ECT

No Intervention: Healthy volunteers
80 healthy volunteers receiving no stimulation



Primary Outcome Measures :
  1. serum BDNF levels [ Time Frame: from baseline to one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652832


Contacts
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Contact: lydie sartelet +33437915531 lydie.sartelet@ch-le-vinatier.fr

Locations
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France
Hopital Le vinatier Recruiting
Bron, France, 69677
Contact: emmanuel poulet, MD, PhD    33437915565      
Principal Investigator: emmanuel poulet, md, phd         
Sub-Investigator: frederic haesebaert, md, phd         
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Study Director: jerome brunelin, PhD CH le vinatier

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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02652832     History of Changes
Other Study ID Numbers: CSR B04
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders