Ignite Creation Date:
2024-05-06 @ 10:30 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03279913
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2017-09-05
Brief Title:
NEUROFEEDSTIM Therapeutic Use of Neurofeedback in Depression in Association With TMS
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
NEUROFEEDSTIM Therapeutic Use of Neurofeedback in Depression in Association With TMS
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUROFEEDSTIM
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-A00809-44 | OTHER | None | None |
| 17051-1 | OTHER | CPP Ouest V Rennes | None |