Insomnia Clinical Trial
— CeresetOfficial title:
Randomized Controlled Trials of Closed-loop Allostatic Neurotechnology to Improve Sensory Function and Pain Management After Traumatic Brain Injury
Verified date | August 2023 |
Source | Brain State Technologies, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI). Study I evaluates symptoms of mTBI through a series of 10 office sessions in which musical tones are echoed, or mirrored back in real time, to reflect one's own brain activity. Those who take part in the study will be randomly assigned to receive either tones that are based on their brain activity/brainwaves, or random tones. Study II evaluates symptoms of mTBI through either 10 office sessions of the same acoustic stimulation linked to brain activity/brainwaves as Study I compared to 5 office sessions of acoustic stimulation plus intermittent very low level electrical stimulation of the scalp linked to brain activity.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | July 1, 2024 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Uniformed Services University | Bethesda | Maryland |
United States | Womack Army Medical Center | Fort Bragg | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Brain State Technologies, LLC | Uniformed Services University of the Health Sciences, Womack Army Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Defense and Veterans Pain Rating Scale | (0) No Pain; to (10) As bad as it could be nothing else matters. | Score decrease three months after enrollment | |
Other | Insomnia Severity Index | 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) | Score decrease three months after enrollment | |
Other | Automated Neuropsychological Assessment Metrics (ANAM) | used to measure simple reaction time and procedural reaction time | improve reaction times three months after enrollment | |
Primary | Neurobehavioral Symptom Inventory (NSI) | 0 = None - Rarely if ever present; not a problem at all and 4= Very Severe - Almost always present and I have been unable to perform at work, school or home due to this problem; I probably cannot function without help. | decrease in the score three months following enrollment | |
Secondary | PATIENT'S GLOBAL IMPRESSION OF CHANGE (PGIC) SCALE | No change (or condition has gotten worse) (1); to
A great deal better and a considerable improvement that has made all the difference (7) |
Score increases three months after enrollment | |
Secondary | HIT-6 Headache Impact Test | based on scale from never (6 pts) to always (13 pts) | improve headache patterns by decreasing point score 3 months after enrollment | |
Secondary | The Dizziness Handicap Inventory ( DHI ) | To each item, the following scores can be assigned:
No=0 Sometimes=2 Yes=4 Scores: Scores greater than 10 points should be referred to balance specialists for further evaluation. 16-34 Points (mild handicap) 36-52 Points (moderate handicap) 54+ Points (severe handicap) Scores are assigned No=0 Sometimes=2 Yes=4; total greater than 10 requires further evaluation and 54+ severe handicap |
Lower the point total for those whose base line is greater than 10 pts at evaluation 3 months following enrollment | |
Secondary | PCL-5 The PTSD Checklist for DSM-5 | Questions scored as 0=not at all; to, 4=Extremely | Lower the score three months after enrollment | |
Secondary | Patient Health Questionnaire-9 (PHQ-9) | Frequency of being bothered by the conditions where 0=not at all; to 3=nearly every day | Lower the score three months after enrollment |
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