(U) USSOCOM. (U) Magnetic qeeg guided Resonance Therapy (MeRT)

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1 United States Special Operations Command (U) USSOCOM MeRT Clinical Trial for Treatment of TBI COL Mark Baggett, Ph.D., US Army USSOCOM Command Psychologist Date: 14 Feb (U) Magnetic qeeg guided Resonance Therapy (MeRT) (U) A subtype of repetitive transcranial magnetic stimulation (rtms) (U) qeeg and biometric data is used to adjust the magnet settings for rtms treatment Biometric variables include resonant heart rate and qeeg variables such as peak alpha frequency are incorporated into an algorithmic equation for rtms settings on the MagVenture system (U) This MeRT Treatment is most focused on the brain areas of cingulate gyrus 2 1

2 (U) MeRT TBI Study (U) A prospective, double blind, randomized, sham-controlled clinical trial (U) Evaluates the safety and efficacy of biometrics-guided Magnetic EEG Resonance Therapy (MeRT) treatment of Traumatic Brain Injury (TBI) (U) FDA Approved Clinical Trial (U) Collaboration between USSOCOM, NBRL and 6 MDG-MacDill AFB 3 (U) Overview (U) USSOCOM Life Cycle Impact and Blast Exposure Staying Left of the Boom (U) What is MeRT General Concept Neuromodulation Therapy (U) Trial Information Overview Inclusion Criteria Exclusion Criteria (U) Future Optimization (U) Information Resources 4 2

3 (U) USSOCOM Life Cycle Impact and Blast Exposure (U) SCHOOLS Jump Dive Breaching (U) COMBAT SIMULATED TRAINING Trainees Instructors Shoot Houses (U) Deployment Exposures Environmental Combatives Drive Ranges Explosives 5 (U) MeRT-Magnetic qeeg Resonance Therapy (U) Neuromodulation: Physiologic regulation of groups of neurons in the Brain. Can be influenced by: Invasive: Deep Brain Stimulation (DBS) Noninvasive: Repetitive Transcranial Magnetic Stimulation (rtms) (U) rtms Technology using magnetic energy to alter neural excitability of the brain. Stimulation frequency used to excite neurons < 1Hz inhibits cortical activity > 1Hz stimulates cortical activity (U) qeeg Measures the Brain s Cortical Electrical Activity (U) MeRT is a form of rtms therapy in which the protocol is individualized by the participant s qeeg 6 3

4 (U) MeRT General Concept (U) Heart-Brain Resonance Resting HR ~1.2 Hz Brain s intrinsic alpha frequency ~9.6 Hz (U) rtms pulses at a harmonic of the resting HR near the alpha frequency (U) MeRT causes subthreshold stimulation at the body s natural resonant frequency (U) Uses Heart-Brain resonance to improve the coherent communication between brain regions (U) MeRT targets frequency, not location. 8-13Hz 7 (U) Physiological mechanism of Action Network Deficiency Hypothesis (U) Dynamic Brain Cell Assemblies are transient coalitions of neurons Activity-specific functional groups Short lived On termination of a process, elements are released to join other functional groups in subsequent activity (U) Physiologic Mechanism of Action Network Deficiency Hypothesis Loss of connectivity and diffuse neuron loss following TBI Result: Failure to form transient brain cell assemblies necessary for efficient stimulus-response coupling Network failures will be reflected in abnormalities in event related inter-regional CNS synchronization, causal networks, and functional connectivity 8 4

5 (U) Physiological mechanism of Action Network Deficiency Hypothesis (U) Conditions Correlated with Abnormalities of EEG Synchronization AD/HD Depression PTSD TBI 9 (U) Study Hypothesis (U) rtms can reset intrinsic frequency of oscillatory neural networks (U) These changes in local network frequency will change entrainment/synchronization behavior (U) A positive clinical response to treatment will be correlated with quantifiable changes in synchronization patterns (U) This study will be the first to assess changes in CNS synchronization behavior in response to rtms treatment. 10 5

6 (U) USSOCOM s FDA Clinical Trial (U) Participants commit to a minimum of 20 treatment sessions 1 Treatment per day 4-6 Consecutive weeks duration (U) Treatment Sessions Consist of: 45 minute duration 6 seconds of pulses, followed by 54 seconds of rest each minute 80% motor threshold (as determined at baseline appointment) Screening Visit Baseline Visit Treatments 1-5 T1) Treatments 6-10 (Follow Up 1 Occurs During Wk2) Treatments Treatments (Follow Up Occurs During Wk4) Possible 2 Wks Additional Treatment Treatment frequency between 8-13 Hz, based on EEG/ECT inputs to proprietary algorithm 11 (U) Inclusion Criteria (U) Must be SOF: Active Duty Reservist or National Guard on Active Orders Retiree of Military Service w/tricare coverage (U) Aged between years (U) TBI Positive according to American Congress of Rehabilitation Medicine (ACRM) criteria with Focal Neurological Deficit(s) and International Statistical Classification of Disease and Related Health Problems (ICD-10) (U) Have no plan to move away, deploy, or TDY/TAD from the commutable area prior to 9 wks after the Baseline 12 6

7 (U) ACRM Inclusion Criteria (U) Any period of loss of consciousness (LOC) (U) Any loss of memory for events immediately before or after the accident (U) Any alteration in mental state at the time of the accident (U) Focal neurological deficit(s) that may or may not be transient 13 (U) ICD-10 Inclusion Criteria (U) The TBI was followed within a maximum of 4 weeks by symptoms in at least 3 of the 6 following categories that have persisted at least 6 months: (U) Headache, dizziness, malaise, fatigue, noise intolerance (U) Irritability, depression, anxiety, emotional lability (U) Subjective concentration, memory, or intellectual difficulties without neuropsychological evidence of marked impairment (U) Insomnia (U) Reduced tolerance for alcohol 14 7

8 (U) Exclusion Criteria (U) History of Open Skull Fracture (U) History of Neurological disorder included but not limited to: Any condition likely associated with increased intracranial pressure a Space Occupying Brain Lesion Seizure disorder (U) History of Cerebrovascular Accident (U) History of Cerebral Aneurysm (U) EEG abnormalities that indicate risk of Seizure 15 (U) Exclusion Criteria (U) Participation in any Interventional Research Protocol within 3 months prior to the Screening Visit (U) Treatment with any anticonvulsant or anxiolytic medication listed on the protocol s exclusionary list within 30 days of the Screening Visit (U) Intracranial Implant (U) Implanted cardiac pacemaker, implantable cardioverter defibrillator, or medication dispensing device (U) Clinically significant abnormality or clinically significant unstable medical condition 16 8

9 (U) Exclusion Criteria (U) Uncontrolled clinically signification medical illness or condition (U) Clinically significant psychopathology (U) History of any type of ECT, MeRT, or rtms treatment (U) Treatment with any antipsychotic medication within 30 days of the Screening Visit (U) Elevated risk of suicide or harm to others (U) Current treatment with any Cognitive Behavioral Therapy or other psychotherapeutic treatment not stable for the preceding 30 days at time of Screening Visit 17 (U) Exclusion Criteria (U) Current medication regimen not stable for 30 days prior to Screening Visit (U) Any condition including inability to comply with study procedures (U) Inability to acquire a satisfactory EEG/ECG on a continual basis (U) Pregnant or Females unwilling to employ effective means of birth control for the duration of the study 18 9

10 (U) Future Optimization (U) Readiness Applications Baseline Pre & Post Deployment Optimization Objective Assessment & Training (U) Clinical Applications Depression Migraines and Chronic Pain PTSD Traumatic Brain Injury 19 (U) For More Information (U) Clinical Trial Information is available at: (U) Investigators (U) CAPT Scott A. Cota, MD-USSOCOM SG: (U) COL Mark Baggett-USSOCOM CMD Psych: (U) LTC Paul Boccio-USSOCOM Deputy Psych: (U) Study Staff (U) MaLisa Lewis-USSOCOM Study Coordinator: 20 10