DepressionNEUROFEEDSTIMNCT03279913
NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS
A study testing EEG-neurofeedback training in association with TMS. in people with Depression, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- EEG-neurofeedback training in association with TMS.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2017to 7 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Depression
- Being tested
- EEG-neurofeedback training in association with TMS.
- Keywords
- Depression, neurofeedback, TMS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-neurofeedback training in association with TMS.Device
EEG-neurofeedback training in association with TMS.
| Study group | Role | What they receive |
|---|---|---|
| EEG-neurofeedback training in association with TMS. | Experimental | EEG-neurofeedback training in association with TMS. Receives: Device: EEG-neurofeedback training in association with TMS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS score
Total score at the MADRS (Montgomery and Asberg Depression Scale) scale: difference between day 1 and day 12.
Measured: Baseline and day 12
Secondary outcomes (9)
MADRS score
Difference at the MADRS score between day 1, day 12 and month 1
Measured: Day 1, day 12 and month 1
BDI score
Difference at the BDI score between day 1, day 12 and month 1
Measured: Day 1, day 12 and month 1
HAM-A score
Difference at the HAM-A score between day 1, day 12 and month 1
Measured: Day 1, day 12 and month 1
TCAQ score
Difference at the TCAQ score between day 1, day 12 and month 1
Measured: 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
Measured: Day 1, day 12 and month 1
SES score
Difference at the SES score between day 1, day 12 and month 1
Measured: Day 1, day 12 and month 1
MHLCS score
Difference at the MHLCS score between day 1, day 12 and month 1
Measured: Day 1, day 12 and month 1
Neuropsychological test
Difference at the neuropsychological performance between day 1, day 12 and month 1
Measured: 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
Measured: Day 1, day 12 and month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start18 Dec 2017
- Primary completion7 Sep 2018
- Study completion7 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Drapier, MD, Principal investigator, Centre Hospitalier Guillaume Regnier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279913
- Sponsor's protocol ID
- 35RC16_8939_NEUROFEEDSTIM
- Other IDs
- 2017-A00809-44, 17/051-1
- Acronym
- NEUROFEEDSTIM
- Status last verified
- Nov 2019
- First submitted
- 5 Sep 2017
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS
- ClinicalTrials.gov ID
- NCT03279913
- Acronym / sponsor ID
- NEUROFEEDSTIM / 35RC16_8939_NEUROFEEDSTIM
- Conditions
- Depression
- Keywords
- Depression, neurofeedback, TMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 7 Sep 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG-neurofeedback training in association with TMS. | Experimental | Device: EEG-neurofeedback training in association with TMS.EEG-neurofeedback training in association with TMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG-neurofeedback training in association with TMS.EEG-neurofeedback training in association with TMS. | Device | EEG-neurofeedback training in association with TMS. |
Primary outcome
MADRS score
Time frame: Baseline and day 12
Total score at the MADRS (Montgomery and Asberg Depression Scale) scale: difference between day 1 and day 12.
9 secondary outcomes
MADRS score
Time frame: Day 1, day 12 and month 1
BDI score
Time frame: Day 1, day 12 and month 1
HAM-A score
Time frame: Day 1, day 12 and month 1
TCAQ score
Time frame: Day 1, day 12 and month 1
BIS-BAS system score
Time frame: Day 1, day 12 and month 1
SES score
Time frame: Day 1, day 12 and month 1
MHLCS score
Time frame: Day 1, day 12 and month 1
Neuropsychological test
Time frame: Day 1, day 12 and month 1
Frontal asymmetry alpha measurement.
Time frame: Day 1, day 12 and month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Drapier, MD principal investigator
Centre Hospitalier Guillaume Regnier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-neurofeedback training in association with TMS. in people with Depression, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS score (time frame: Baseline and day 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.