Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT03649958
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03649958
Study Brief:
Protocol Section:
NCT03649958