NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS (NEUROFEEDSTIM)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EEG-neurofeedback training in association with TMS.
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, neurofeedback, TMS
Eligibility Criteria
Inclusion Criteria:
- Patient with a major depressive episode (DSM IV-TR 296) with an indication of TMS (whether or not they have previously benefited from TMS);
- Aged 18 and over;
- With a score greater than or equal to 15 at the MADRS;
- Under stable and unchanged pharmacological treatment for at least one month;
- Having signed a free and informed consent to participate in the study.
Non inclusion Criteria:
- Other psychiatric disorder of axis 1 of DSM IV-TR (schizophrenia, substance abuse / dependence, ...);
- Neurological or dementia history according to DSM criteria;
- Pregnant or nursing women;
- Major persons subject to legal protection (safeguard of justice, curators, guardianship);
- Participation in another research involving the human interventionist or at risk and minimal constraints
- Confined hospitalized patients (SDT, SDRE).
Sites / Locations
- Centre Hospitalier Guillaume Régnier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EEG-neurofeedback training in association with TMS.
Arm Description
EEG-neurofeedback training in association with TMS.
Outcomes
Primary Outcome Measures
MADRS score
Total score at the MADRS (Montgomery and Asberg Depression Scale) scale: difference between day 1 and day 12.
Secondary Outcome Measures
MADRS score
Difference at the MADRS score between day 1, day 12 and month 1
BDI score
Difference at the BDI score between day 1, day 12 and month 1
HAM-A score
Difference at the HAM-A score between day 1, day 12 and month 1
TCAQ score
Difference at the TCAQ score between day 1, day 12 and month 1
BIS-BAS system score
Difference at the BIS-BAS system score between day 1, day 12 and month 1
SES score
Difference at the SES score between day 1, day 12 and month 1
MHLCS score
Difference at the MHLCS score between day 1, day 12 and month 1
Neuropsychological test
Difference at the neuropsychological performance between day 1, day 12 and month 1
Frontal asymmetry alpha measurement.
Difference at the frontal asymmetry alpha between day 1, day 12 and month 1
Full Information
NCT ID
NCT03279913
First Posted
September 5, 2017
Last Updated
November 5, 2019
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03279913
Brief Title
NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS
Acronym
NEUROFEEDSTIM
Official Title
NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
September 7, 2018 (Actual)
Study Completion Date
September 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neurofeedback is an increasingly researched technique for the treatment of many psychological disorders, such as attention deficit / hyperactivity disorder (AD / HD), depression, or substance abuse. This technique would allow patients to regulate their cortical electroencephalographic activity while receiving a visual or auditory feedback on the cortical electroencephalographic activity. Changes in the electroencephalogram (EEG) would thus be correlated with changes in cortical activity and thus with symptoms.
On the electroencephalographic plane, the depression appears associated with relatively more alpha activity (in "resting state", 8-13 Hz) in left than in right frontal cortex. This difference in alpha activity between frontal regions is known as alpha asymmetry in depression. As a reminder, increased alpha activity indicates a decrease in cortical activation. This alpha asymmetry appears to be associated with a decrease in sensitivity to reward.
It is on these bases that the modification of the alpha asymmetry has become one of the most frequent objectives of the studies on the use of neurofeedback in depression.
Transcranial magnetic stimulation (TMS) also offers a non-invasive and painless method of effective cerebral stimulation in psychiatric disorders and especially depression. It received a favorable opinion from the Food & Drug Administration (FDA) in the United States for the treatment of this pathology. This treatment is still under evaluation in France. The results are promising but improvements must be done to increase its effectiveness.
TMS offers stimulation of brain tissue in a localized and non-invasive manner. The principle consists of a brief electric current passing through a coil which generates a transient magnetic field inducing an electric field through conductive fabrics. TMS modifies neuronal activity in target superficial brain structures, but also modulates neuronal circuit activity.
In recent years, the concept of "state dependency TMS" has been developed. It suggests that the activation state of neuronal circuits before and after stimulation alters the effect of stimulation. Thus, the efficacy of TMS could be amplified in depression by taking into account the cerebral activity during the stimulation sessions, in particular on the electroencephalographic plane.
However, TMS may also help patients increase their EEG response during Neurofeedback sessions.
The combination of stimulation techniques and brain-machine interfaces such as neurofeedback is still little studied at present.
A study on the combined use of TMS and Neurofeedback by EEG in depression would therefore be an innovative approach and in line with the latest data from the literature.
Design : Prospective, monocentric, non-randomized, non-comparative, unblinded study.
Detailed Description
Primary objective : To demonstrate a decrease in the intensity of depressive symptomatology following EEG-neurofeedback training in association with TMS and see if there is a correlation with a change in frontal asymmetry.
Secondary objective : To demonstrate a cognitive improvement in patients with respect to motivation and control of thoughts, as well as perceived health, self-esteem and anxiety following EEG-neurofeedback training in association with TMS and to see if there is a correlation between the change in scores on psychometric scales with a change in frontal asymmetry.
The expected outcomes of this study are:
Better characterization of the pathophysiological processes involved in depressive disorder;
An evaluation of the effectiveness of EEG-Neurofeedback training in recurrent depressive disorder in association with TMS, both emotionally and cognitively;
The development of innovative technologies in the field of brain-machine interfaces and optimization of procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, neurofeedback, TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EEG-neurofeedback training in association with TMS.
Arm Type
Experimental
Arm Description
EEG-neurofeedback training in association with TMS.
Intervention Type
Device
Intervention Name(s)
EEG-neurofeedback training in association with TMS.
Intervention Description
EEG-neurofeedback training in association with TMS.
Primary Outcome Measure Information:
Title
MADRS score
Description
Total score at the MADRS (Montgomery and Asberg Depression Scale) scale: difference between day 1 and day 12.
Time Frame
Baseline and day 12
Secondary Outcome Measure Information:
Title
MADRS score
Description
Difference at the MADRS score between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
BDI score
Description
Difference at the BDI score between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
HAM-A score
Description
Difference at the HAM-A score between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
TCAQ score
Description
Difference at the TCAQ score between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
BIS-BAS system score
Description
Difference at the BIS-BAS system score between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
SES score
Description
Difference at the SES score between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
MHLCS score
Description
Difference at the MHLCS score between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
Neuropsychological test
Description
Difference at the neuropsychological performance between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
Title
Frontal asymmetry alpha measurement.
Description
Difference at the frontal asymmetry alpha between day 1, day 12 and month 1
Time Frame
Day 1, day 12 and month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with a major depressive episode (DSM IV-TR 296) with an indication of TMS (whether or not they have previously benefited from TMS);
Aged 18 and over;
With a score greater than or equal to 15 at the MADRS;
Under stable and unchanged pharmacological treatment for at least one month;
Having signed a free and informed consent to participate in the study.
Non inclusion Criteria:
Other psychiatric disorder of axis 1 of DSM IV-TR (schizophrenia, substance abuse / dependence, ...);
Neurological or dementia history according to DSM criteria;
Pregnant or nursing women;
Major persons subject to legal protection (safeguard of justice, curators, guardianship);
Participation in another research involving the human interventionist or at risk and minimal constraints
Confined hospitalized patients (SDT, SDRE).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Drapier, MD
Organizational Affiliation
Centre Hospitalier Guillaume Regnier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Guillaume Régnier
City
Rennes
State/Province
Britanny
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS
We'll reach out to this number within 24 hrs