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Neurofeedback Using TMS as an Assessment Tool

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Doron Todder, Beersheva Mental Health Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993316
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Doron Todder, Beersheva Mental Health Center
  Purpose

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 Intervention
Brain Diseases Device: Mitsar 201 neurofeedback

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validating of Neurofeedback Practice by Utilizing TMS as an Assessment Tool

Resource links provided by NLM:


Further study details as provided by Doron Todder, Beersheva Mental Health Center:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • EEG amplifier used for neurofeedback:
  • Mitsar 201 SN: 1070534-09

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male or female

Exclusion Criteria:

  • medical history of major psychitric disorder
  • known disorder of central nervous system, specifically history of seizures
  • first order relative diagnosed with epilepsy
  • head injury or finding of head trauma after routine imaging
  • pregnancy
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Israel
Beersheva Mental Health Center Not yet recruiting
Beersheva, Israel
Contact: Doron Todder, MD, PhD    972 8-6401767    doron@neuroclinic.co.il   
Sponsors and Collaborators
Beersheva Mental Health Center
Investigators
Principal Investigator: Doron Todder, MD, PhD Beersheva Mental Health Center
  More Information

Responsible Party: Doron Todder, Director, Clinical Neurophysiology Unit, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT01993316     History of Changes
Other Study ID Numbers: neurofeedbackTMS1
First Submitted: August 14, 2013
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by Doron Todder, Beersheva Mental Health Center:
neurofeedback
EEG
transcranial magnetic stimulation

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases