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

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Unknown status
CT.gov ID
NCT02652832
Collaborator
(none)
200
Enrollment
1
Location
8
Arms
102.9
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: non invasive brain stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2010
Anticipated Primary Completion Date :
Dec 31, 2018
Anticipated Study Completion Date :
Jun 30, 2019

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. serum BDNF levels [from baseline to one month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Le vinatier Bron France 69677

    Sponsors and Collaborators

    • Hôpital le Vinatier

    Investigators

    • Study Director: jerome brunelin, PhD, CH le vinatier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hôpital le Vinatier
    ClinicalTrials.gov Identifier:
    NCT02652832
    Other Study ID Numbers:
    • CSR B04
    First Posted:
    Jan 12, 2016
    Last Update Posted:
    Aug 1, 2018
    Last Verified:
    Feb 1, 2018
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Aug 1, 2018