STUDY TITLE: Flexyx Neurotherapy System Treatment for Traumatic Brain Injury and Post Traumatic Stress Disorder for Veterans of the Afghanistan and Iraq Wars
PRINCIPAL INVESTIGATOR: Mary Lee Esty, LCSW-C, PhD
SPONSOR: Neurotherapy Center of Washington
7920 Norfolk Ave. #200
Bethesda, MD 20814
(301) 652-7175
PURPOSE: Participants are invited to join in this research study because they have been diagnosed with Traumatic Brain Injury (TBI) and/or Post Traumatic Stress
Disorder (PTSD). The purpose of this study is to determine whether a relatively new treatment method called the Flexyx Neurotherapy System (FNS) is
effective for reducing TBI and PTSD symptoms. About 15 persons will take part in this study at the Neurotherapy Center of Washington.
PROCEDURES:
First, you will be asked to complete some research questionnaires about your symptoms, including cognitive issues (e.g., attention, concentration,
problems), emotions/mood, fatigue, pain, and sleep. These will take, at most, one hour. Then you will have an
interview to see if you meet the initial criteria for being included in the study. This will take about one hour and will include a psychosocial history,
review of your medical condition, and some questions about your emotional status. Then an evaluation of your brainwave (electroencephalogram or EEG)
functioning (also called “mapping”) will be conducted. The evaluation session will take a total of about 2˝ hours for the complete process including
questionnaires.
Over a period of eight to nine months, your time commitment will involve the following. In addition to the screening procedures described above, there
will be one-half hour treatment sessions two or three times per week over a period of two to three months for a total of 25 treatment sessions. During the 12th and 25th sessions, and again
at 3- and 6-month follow-up, there will be a repeat of the EEG mapping (approximately 1 hour), and you will be asked to again complete the same
questionnaires (an additional one hour maximum).
You will also be asked to complete some of the research questionnaires every five sessions and at the 3- and 6-month follow-up sessions. Also, at each
treatment session you will be asked to complete three short questionnaires.
For more information on this study, call 301-652-7175 and ask to speak to a therapist.
STUDY TITLE: Flexyx Neurotherapy and Surface Electromyography Treatments for Fibromyalgia
PRINCIPAL INVESTIGATORS: Mary Lee Esty, LCSW-C, PhD and Emily Perlman, MS, BCIA
SPONSOR: Neurotherapy Center of Washington
7920 Norfolk Ave. #200
Bethesda, MD 20814
(301) 652-7175
PURPOSE:
Participants are invited to join in this research study because they have fibromyalgia. The purpose of this study is to determine whether a relatively new
treatment method called the Flexyx Neurotherapy System (FNS) is effective for reducing fibromyalgia symptoms. About 15 persons will take part in this
study at the Neurotherapy Center of Washington.
If you agree to join and do not withdraw later, you will be in this study for about 10 to 11 months depending upon your group assignment.
PROCEDURES:
First, you will have a brief interview to see if you meet the initial criteria for being included in the study. This will take about one hour and will
include a history of your medical condition and some questions about your emotional status. Your physician will be asked to confirm the diagnosis of
fibromyalgia as part of acceptance into the study. If you meet the criteria, then an evaluation of your brainwave (electroencephalogram or EEG) functioning
(also called “mapping”) will be conducted. In addition, an evaluation of certain muscle activity patterns (by means of procedures called surface
electromyography or sEMG) will be conducted. You must consult your physician before, however, because you are asked to be off of medications for pain,
depression, and/or anxiety for 48 hours prior to the evaluations. You and your physician can decide if that is possible, and we can discuss your particular
situation with you. These evaluation sessions will take about 2˝ hours.
After meeting EEG mapping criteria and the sEMG evaluation criteria for acceptance into the study, you will be asked to complete some research questionnaires
about your symptoms, including pain, cognitive issues (e.g., attention, concentration, memory problems), fatigue, mood, and sleep, and activity patterns.
You will be asked to complete the research questionnaires every five sessions and at the 3- and 6-month follow-up sessions. These will take, at most, one
hour.
On a random basis (like the flip of a coin), you will be assigned to one of three study groups. One group will undergo the FNS therapy only. The
other two groups will receive eight sEMG treatments either before or after receiving FNS treatments. All groups will receive 28 treatment sessions
regardless of assignment. FNS sessions will occur about 1-2 times per week and sEMG sessions will occur only one time per week.
Over a period of 10 to 11 months, your time commitment will involve the following. In addition to the screening procedures described above, there will be
28 one-half hour weekly or bi-weekly treatment sessions over a period of approximately 3˝ to 4˝ months, depending upon your group assignment. Immediately
at the conclusion of the treatment sessions and again at 3- and 6-month follow-up, there will be a repeat of the EEG mapping and sEMG evaluations, and you
will be asked to again complete the same questionnaires (an additional one hour maximum).
For more information on this, call 301-652-7175 and ask to speak to a therapist.
