Neurofeedback Using TMS as an Assessment Tool

NCT01993316 | Unknown

• 1 other identifier: neurofeedbackTMS1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Diseases

Keywords

neurofeedback; EEG; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• EEG

  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.

  20 minutes

Study Arms (1)

neurofeedback training

EXPERIMENTAL

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

Interventions

Mitsar 201 neurofeedback DEVICE

Also known as: EEG amplifier used for neurofeedback:, Mitsar 201 SN: 1070534-09

neurofeedback training

Eligibility Criteria

• Age: 22 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• Beersheva Mental Health Center: lead

Study Sites (1)

Beersheva Mental Health Center

Beersheva, Israel

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Doron Todder, MD, PhD

  Beersheva Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Neurophysiology Unit

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

IL (1)