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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
8
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