This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic Concussive Syndrome (CCS).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Reviewed and personally signed and dated informed consent document indicating that the participant (or legally acceptable representative) has been informed of and understands all pertinent aspects of the study.
✓. Confirmed Diagnosis of Chronic Concussive Syndrome/Post-Concussive Syndrome: At least three (3) of the following criteria must be met to confirm diagnosis:
✓. Female participants of child bearing potential and at risk of pregnancy during the study must agree to use 2 highly effective methods of contraception throughout the study and for 112 days after the last study visit.
✓. Female participant who are not of childbearing potential (i.e. must meet at least one (1) of the following criteria):
✓. Individuals who are willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures through the end of the final study visit
✓. Individuals Aged 18 to 65 at the time of screening and enrollment.
Exclusion criteria
✕. Any cardiac pathologies or conditions which may risk the participant or interfere with the ability to interpret the results. Signs and symptoms of clinically significant cardiac disease including but not limited to:
✕. History of transient ischemic attack in the 6 months prior to screening, diagnosis of stroke with residual deficits (eq. aphasia, substantial motor or sensory deficits) diagnosis of stroke with residual deficits (eq. aphasia, substantial motor or sensory deficits) that would preclude completion of required study activities
✕
What they're measuring
1
Health Status using the 36 item Short Form Health Survey (SF-36)
Timeframe: Baseline, 1 month and 6 months post treatment
2
Assessment of Visual Attention and Task Switching
Timeframe: Baseline, 1 month and 6 months post treatment
3
Assessment of Contextual Verbal Learning
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
4
Assessment of Verbal Fluency
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
5
Assessment of Attention and Executive functions
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
6
Assessment of Unstructured Verbal Learning and Memory
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
7
Assessment of Visuospatial Learning and Memory
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
. Resting, sitting blood pressure (BP) ≥ 160 mm Hg in systolic pressure or ≥ 100 mm Hg in diastolic pressure at screening. If a participant is found to have untreated significant hypertension at screening and antihypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month prior to screening
✕. Participants who have evidence of orthostatic hypotension based upon replicate orthostatic blood pressure measurements. If orthostatic blood pressure change is not able to be determined (e.g., unable to establish a stable supine systolic and diastolic blood pressure) the participant is not eligible for the study
✕. Individuals with a history of Deep Vein Thrombosis (DVT) or pulmonary embolism
✕. Individuals with a history or family history of thrombophilia such as Factor V Leiden
✕. Individuals that have had stents implanted within the past year
✕. Individuals that are currently being treated with an anticoagulant medication
Assessment of Symptoms of Anxiety over Time
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
9
Assessment of Pain
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
10
Assessment of Sleep Quality
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
11
Assessment of Treatment by Participant
Timeframe: Baseline, 1 month post treatment and 6 months post treatment
12
Assessment of Depression by Participant
Timeframe: Baseline, 1 month post treatment and 6 months post treatment