NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS

NCT03279913 | Completed

• 3 other identifiers: 35RC16_8939_NEUROFEEDSTIM2017-A00809-4417/051-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression, neurofeedback, TMS

Outcome Measures

Primary Outcomes (1)

• MADRS score

  Total score at the MADRS (Montgomery and Asberg Depression Scale) scale: difference between day 1 and day 12.

  Baseline and day 12

Secondary Outcomes (9)

• MADRS score

  Day 1, day 12 and month 1

• BDI score

  Day 1, day 12 and month 1

• HAM-A score

  Day 1, day 12 and month 1

• TCAQ score

  Day 1, day 12 and month 1

• BIS-BAS system score

  Day 1, day 12 and month 1

Study Arms (1)

EEG-neurofeedback training in association with TMS.

EXPERIMENTAL

EEG-neurofeedback training in association with TMS.

Device: EEG-neurofeedback training in association with TMS.

Interventions

EEG-neurofeedback training in association with TMS. DEVICE

EEG-neurofeedback training in association with TMS.

EEG-neurofeedback training in association with TMS.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Centre Hospitalier Guillaume Régnier

Rennes, Britanny, 35000, France

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Dominique Drapier, MD

  Centre Hospitalier Guillaume Regnier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 12, 2017
• Study Start: December 18, 2017
• Primary Completion: September 7, 2018
• Study Completion: September 7, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)