Neurofeedback Using TMS as an Assessment Tool
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|ClinicalTrials.gov Identifier: NCT01993316|
Recruitment Status : Unknown
Verified November 2013 by Doron Todder, Beersheva Mental Health Center.
Recruitment status was: Not yet recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Neurofeedback can be described as a form of biofeedback which is based on recording brain activity; usually by using scalp EEG. Neurofeedback has been used for 40 years as a therapeutic treatment for many neurological conditions including epilepsy, attention deficit hyperactivity disorder and also to improve mental performance in healthy subjects. Participants can "see" their brain activity via the EEG readings and receive positive feedback (visual or auditory) to help them consciously shape their brain waves into the desired patterns.
sLORETA, which is speciliazed computer program to analyze EEG results, will be used in conjuntion with EEG to study the effect of neurofeedback on the brain activity of healthy subjects.
In this study we will investigate the effect of neurofeedback training using sLORETA, which is a specific method to measure brain waves. We will measure the effect on both brain hemispheres both before and after neurofeedback training.
|Condition or disease||Intervention/treatment||Phase|
|Brain Diseases||Device: Mitsar 201 neurofeedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validating of Neurofeedback Practice by Utilizing TMS as an Assessment Tool|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: neurofeedback training
Subjects will undergo neurofeedback training to either the right primary motor cortex or the right superior parietal gyrus. The EEG measurements will be analyzed using LORETA.
Device: Mitsar 201 neurofeedback
- EEG [ Time Frame: 20 minutes ]
We will place a 19 electrode EEG hat on the participants . All equipment and materials that will be used are approved for clinical and research use and are been routinely used in the hospital in variable treatments protocols and therefore can be considered safe.
Participants will be prepared for EEG recording using a measure of the distance between the nasion and inion to determine the appropriate cap size for recording. The head will be measured and marked prior to each session to maintain consistency. The ears and forehead will be cleaned for recording with a mild abrasive gel to remove any oil and dirt from the skin. After ﬁtting the caps, each electrode site will be injected with electrogel and prepared so that impedances between individual electrodes and each ear will be less than 5KΩ. Training will be conducted using the 19-leads standard international 10/20 system. Preparation process should take no more than 20 minutes and will cause no distress to the participant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993316
|Beersheva Mental Health Center|
|Contact: Doron Todder, MD, PhD 972 8-6401767 email@example.com|
|Principal Investigator:||Doron Todder, MD, PhD||Beersheva Mental Health Center|