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2018 BrainMaster study, 147 published research articles from 2003-2018

A 2018 BrainMaster Post Market Clinical Follow-up study, completed for ISO/European Union Medical Device Regulations, found BrainMaster EEG devices used increasingly for research from 2003 to 2018. From a comprehensive literature search, the study identified 147 research articles published from 20 countries. 

BrainMaster EEG devices were used in research of 4,231 clients; 78% were adults and 22% were children and teens. EEG biofeedback was used for a wide variety of conditions, including the treatment of ADHD, chronic pain, depression, anxiety, and optimizing performance in healthy individuals.

One Emergency Room study (Brenner et al, 2015) found the BrainMaster Atlantis device comparable to a 23-lead Hospital EEG in detecting epileptic spike EEG. 

The 20 countries conducting research were mainly the USA and European countries. Additionally, Middle Eastern, Pacific Rim and Eastern countries included Israel, Iran, Australia, Singapore, Japan, Malaysia, China, Taiwan, Thailand, South Korea, and India.

There were no serious adverse events from the use of BrainMaster EEG devices in the 16 years of research in 20 countries. However, mild, transient side effects were experienced by 0.4% of clients, that is, 1 person out of 250. The predominant side effect was a temporary headache that may be due to the type of training protocol used in the particular research study. Side effects are not due to the device itself, rather, it appears to be due to protocols using intense, prolonged concentration.

 

         SUMMARY of 2003-2018 BrainMaster Device Research

  • 147 research studies between 2003-2018, total subjects= 4,231
  • Peer-reviewed research publications=57 (39%) published studies
  • Case Series & Case studies= 61 (41%)
  • Book chapters = 14 (10%)
  • Dissertations/theses = 10 (7%)
  • online published= 5 (3%)
  • 38 research studies (26%) were high quality Level 2 or Level 3 using Oxford Evidence-Based Medicine (2009) ratings
  • 24 of the high-quality studies were RCT (16 %= Randomized Controlled Trials).
  • 51 studies had a control group out of the 147 studies (35 %)
  • One Emergency Room study (Brenner, 2015) found Atlantis device comparable to 23-lead Hospital EEG

                      in detecting epileptic spike EEG

  • Discovery device used in 90 studies (61%), Atlantis used in 57 (39%).
  • Out of 147 studies, 74 used QEEG (50% used QEEG).
  • Total subjects= 4231 [ 3315 adults (78%) + 916 kids/teens (22%)]
  • studies used N=1933 (45%) healthy subjects.
  • studies used N=1806 (43%) Psych subjects, primarily ADHD.
  • studies used N=492 (12%) medical-neurological subjects.
  • Side Effects = 0.4% (0.004 of 4231) had transient SE's (primarily transient headache or tiredness). This is equal to 1 of every 250 people.
  • Adverse Events= 0.00%=NONE



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