DepressionPlasti-StimNCT02652832
Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
A study testing non invasive brain stimulation in people with Depression and Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Schizophrenia
- What is being tested?
- non invasive brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to 11 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression, Schizophrenia
- Being tested
- non invasive brain stimulation
- Medical subject headings
- Depression, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non invasive brain stimulationDevice
Also called rTMS, tDCS, ECT
non invasive brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| Depression Electroconvulsive therapy | Active comparator | 40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy Receives: Device: non invasive brain stimulation |
| Depression active repetitive transcranial magnetic stimulation | Active comparator | 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 Receives: Device: non invasive brain stimulation |
| Depression sham repetitive transcranial magnetic stimulation | Sham comparator | 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 Receives: Device: non invasive brain stimulation |
| Schizophrenia active transcranial magnetic stimulati | Active comparator | 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 Receives: Device: non invasive brain stimulation |
| Schizophrenia sham transcranial magnetic stimulation | Sham comparator | 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 Receives: Device: non invasive brain stimulation |
| Schizophrenia active transcranial Direct Current Stimulation | Active comparator | 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 Receives: Device: non invasive brain stimulation |
| Schizophrenia sham transcranial Direct Current Stimulation | Sham comparator | 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 Receives: Device: non invasive brain stimulation |
| Healthy volunteers | No intervention | 80 healthy volunteers receiving no stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum BDNF levels
Measured: from baseline to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startDec 2010
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Why it stopped: le Professeur Emmanuel POULET investigateur principal ayant quitté le Centre hospitalier Le Vinatier .
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jerome brunelin, PhD, Study director, CH le vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652832
- Sponsor's protocol ID
- CSR B04
- Acronym
- Plasti-Stim
- Status last verified
- Jun 2026
- First submitted
- 19 Oct 2015
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels
- ClinicalTrials.gov ID
- NCT02652832
- Acronym / sponsor ID
- Plasti-Stim / CSR B04
- Conditions
- Depression, Schizophrenia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: le Professeur Emmanuel POULET investigateur principal ayant quitté le Centre hospitalier Le Vinatier .
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Depression Electroconvulsive therapy | Active comparator | Device: non invasive brain stimulation40 patients with major depression receiving a mean of 12 sessions of Electroconvulsive therapy |
| Depression active repetitive transcranial magnetic stimulation | Active comparator | Device: non invasive brain stimulation40 patients with major depression receiving a mean 4 weeks of 1 Hz repetitive transcranial magnetic stimulation applied over the right dorsolateral prefrontal cortex - DLPFC |
| Depression sham repetitive transcranial magnetic stimulation | Sham comparator | Device: non invasive brain stimulation40 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 |
| Schizophrenia active transcranial magnetic stimulati | Active comparator | Device: non invasive brain stimulation40 patients with schizophrenia and predominant negative symptoms receiving 20 sessions of intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC |
| Schizophrenia sham transcranial magnetic stimulation | Sham comparator | Device: non invasive brain stimulationpatients with schizophrenia and predominant negative symptoms receiving 20 sessions of sham intermittent theta burst simulation (iTBS) applied over the left dorsolateral prefrontal cortex - DLPFC |
| Schizophrenia active transcranial Direct Current Stimulation | Active comparator | Device: non invasive brain stimulation40 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 |
| Schizophrenia sham transcranial Direct Current Stimulation | Sham comparator | Device: non invasive brain stimulation40 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 |
| Healthy volunteers | No intervention | –80 healthy volunteers receiving no stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- less than 18 years old
- pregnancy
- received benzodiazepine
- bipolar disorder
- other axis I of DSM IV diagnosis (excluding for Tobacco use disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non invasive brain stimulationAlso: rTMS, tDCS, ECTnon invasive brain stimulation | Device | Depression Electroconvulsive therapy, Depression active repetitive transcranial magnetic stimulation, Depression sham repetitive transcranial magnetic stimulation, Schizophrenia active transcranial Direct Current Stimulation, Schizophrenia active transcranial magnetic stimulati, Schizophrenia sham transcranial Direct Current Stimulation, Schizophrenia sham transcranial magnetic stimulation |
Primary outcome
serum BDNF levels
Time frame: from baseline to one month
Results and safety
The study was stopped early (reason given: le Professeur Emmanuel POULET investigateur principal ayant quitté le Centre hospitalier Le Vinatier .). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jerome brunelin, PhD study director
CH le vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non invasive brain stimulation in people with Depression and Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: le Professeur Emmanuel POULET investigateur principal ayant quitté le Centre hospitalier Le Vinatier .). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum BDNF levels (time frame: from baseline to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.