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

Primary Purpose

Depression, Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
non invasive brain stimulation
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Hopital Le vinatierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

No Intervention

Arm Label

Depression Electroconvulsive therapy

Depression active repetitive transcranial magnetic stimulation

Depression sham repetitive transcranial magnetic stimulation

Schizophrenia active transcranial magnetic stimulati

Schizophrenia sham transcranial magnetic stimulation

Schizophrenia active transcranial Direct Current Stimulation

Schizophrenia sham transcranial Direct Current Stimulation

Healthy volunteers

Arm Description

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

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

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

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

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

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

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

80 healthy volunteers receiving no stimulation

Outcomes

Primary Outcome Measures

serum BDNF levels

Secondary Outcome Measures

Full Information

First Posted
October 19, 2015
Last Updated
July 31, 2018
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT02652832
Brief Title
Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
Acronym
Plasti-Stim
Official Title
Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Schizophrenia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depression Electroconvulsive therapy
Arm Type
Active Comparator
Arm Description
40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy
Arm Title
Depression active repetitive transcranial magnetic stimulation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Depression sham repetitive transcranial magnetic stimulation
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Schizophrenia active transcranial magnetic stimulati
Arm Type
Active Comparator
Arm Description
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
Arm Title
Schizophrenia sham transcranial magnetic stimulation
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Schizophrenia active transcranial Direct Current Stimulation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Schizophrenia sham transcranial Direct Current Stimulation
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Healthy volunteers
Arm Type
No Intervention
Arm Description
80 healthy volunteers receiving no stimulation
Intervention Type
Device
Intervention Name(s)
non invasive brain stimulation
Other Intervention Name(s)
rTMS, tDCS, ECT
Intervention Description
non invasive brain stimulation
Primary Outcome Measure Information:
Title
serum BDNF levels
Time Frame
from baseline to one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lydie sartelet
Phone
+33437915531
Email
lydie.sartelet@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jerome brunelin, PhD
Organizational Affiliation
CH le vinatier
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Le vinatier
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
emmanuel poulet, MD, PhD
Phone
33437915565
First Name & Middle Initial & Last Name & Degree
emmanuel poulet, md, phd
First Name & Middle Initial & Last Name & Degree
frederic haesebaert, md, phd

12. IPD Sharing Statement

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Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels

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