Neurotechnology Following Traumatic Brain Injury (Cereset)

This is an interventional treatment trial for Post-Concussion Symptoms focused on measuring concussion, mTBI, headache, insomnia, PTS, anxiety, pain, depression, sleep Read More

Inclusion Criteria:

• 1 Must have symptoms related to concussion or TBI, not healthy controls Age 18 years or older.
• 2 Active duty or retired military service member, or dependent beneficiary.
• 3 History of mild TBI, confirmed by administration of the Ohio State University TBI
• Identification Method Interview.
• 4 At least three months, and no more than ten years, since their most recent TBI.
• 5 Persistent symptoms temporally related, or otherwise attributable to, the TBI, such as
• headache or chronic pain, sensory disturbance including auditory, visual or other sensory
• symptoms, balance difficulties, or dizziness. After obtaining informed consent, sufficient
• severity of symptoms for entry into the study will be confirmed by administration of the
• Neurobehavioral Symptom Inventory (NSI), with a score of 23 or higher required for
• inclusion.
• 6 Willingness to be randomly assigned to one of the two treatment groups and to provide
• data for all study measures.
• 7 Willingness to abstain from alcohol or recreational drug use throughout the intervention
• period and up to 3 weeks after completion of the final office-based intervention session.
• This abstention period is intended to support the stabilization of new brain activity
• patterns that may result from the intervention.
• 8 For individuals using any of the following medication classes (either regularly scheduled
• or PRN), a willingness both to discontinue or hold those medications at least five (5) halflives
• prior to the initiation of study procedures, and throughout the period of participation
• in the study, as well as to sign a release enabling contact between study staff and their
• prescribing provider, to ensure that the prescriber deems that holding said medication
• during the study period is permissible and reasonable: benzodiazepines, opioids, antipsychotics,
• mood-stabilizers, anti-convulsants, non-benzodiazepine sleep aids (including
• but not limited zolpidem, eszoplicone, zaleplon, trazadone, and diphenhydramine), other
• prescribed sedative-hypnotics, or medical marijuana or cannabinoid medication.
• 9 Willingness to abstain from initiation of PRN/as needed usage of the above listed
• medications throughout the period of study participation. This criterion only applies to
• new PRN prescription or usage. There is no requirement to abstain from a new, regularly scheduled prescription for one of the above medications during the course of the study, if the participant's provider
• deems such usage to be indicated. The potential impact of the initiation of any such
• medications during the study will be assessed by conducting sensitivity analyses after the
• completion of the study.
• 10 Willingness to alert study investigators of any changes in their medication usage
• throughout the course of their study participation.

Exclusion Criteria:

• 1 Unable or unwilling to demonstrate an understanding of the nature and intent of the
• study, and/or to complete informed consent procedures.
• 2 A history of moderate or severe TBI.
• 3 The diagnosis of a psychotic disorder (including schizophrenia and schizoaffective
• disorder), severe depression (PHQ-9 score > 20), bipolar disorder, or active suicidal or
• homicidal ideation.
• 4 Physically unable to come to the study visits, or to sit in a chair for up to two hours.
• 5 Inability to hear and repeat a phrase spoken at normal conversational volume.
• 6 Meeting criteria for a current alcohol or substance use disorder.