Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels

Depression Clinical Trial

— Plasti-Stim  

Official title:

Effects of Noninvasive Brain Stimulation Techniques on BDNF Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02652832
• Other study ID #: CSR B04
• Status: Recruiting
• Phase: N/A
• Start date: December 2010
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2018
• Source: Hôpital le Vinatier
• Contact: lydie sartelet
• Phone: +33437915531
• Email: lydie.sartelet[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Schizophrenia

Intervention

Device:
• non invasive brain stimulation
non invasive brain stimulation

Locations

Country	Name	City	State
France	Hopital Le vinatier	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum BDNF levels		from baseline to one month