Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Healthy Volunteers: f
View:

• Male and female adults and children aged 11 years and older.

• Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.

• Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.

• Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.

Locations
United States
North Carolina
Department of Neurology, Wake Forest School of Medicine
Winston-salem
Time Frame
Start Date: 2011-08-23
Completion Date: 2018-10-25
Participants
Target number of participants: 300
Treatments
Experimental: Active HIRREM
This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.
Authors
Charles H Tegeler, Sandhya R Kumar
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov