NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS
NCT03279913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2019-11-06
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.
Conditions
Interventions
- DEVICE
-
EEG-neurofeedback training in association with TMS.
EEG-neurofeedback training in association with TMS.
Sponsors & Collaborators
-
Rennes University Hospital
lead OTHER
Principal Investigators
-
Dominique Drapier, MD · Centre Hospitalier Guillaume Regnier
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-18
- Primary Completion
- 2018-09-07
- Completion
- 2019-09-07
Countries
- France
Study Locations
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