Concussion, Mild Clinical Trial
Official title:
Clinical Characteristics and Pathophysiology of Post-Traumatic Headache
Verified date | December 2018 |
Source | Danish Headache Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To better understand the clinical characteristics and complex pathophysiological events that constitute persistent post-traumatic headache (PPTH) and to identify possible calcitonin gene-related peptide (CGRP) hypersensitivity in PPTH patients.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 1, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria for PPTH patients: - 18-65 years of age - Subject has PPTH in accordance with the diagnostic criteria of the International Headache Society (IHS) - Concussion (mild traumatic brain injury) occured > 12 months ago - Subject, who are fertile women, must be on safe contraceptives Exclusion Criteria for PPTH patients: - Pre-trauma existing primary headache disorder (maximum 1 day/per month with tension-type headache) and medication-overuse headache - > 1 episode with a sustained concussion - Whiplash - Pregnant or lactating women - Cardiovascular disease of any kind - Hypertension on the experimental day - Hypotension on the experimental day - Pre-trauma existing psychiatric disorder of any kind - unless well-regulated - Any anamnestic or clinical signs of any kind deemed relevant for the study by the physician examining the subject - Any MRI contraindication and a wish of not being informed about unexpected MRI changes |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Headache Center | Glostrup |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache Characteristics | Headache characteristics will be assessed using a semi-structured interview. | 50 minutes | |
Primary | Headache Characteristics | Headache characteristics will be assessed using Headache Under-Response to Treatment Index (HURT-Index) questionnaire. The total score ranges from 0 to 24 with a higher score indicating a lower effectiveness of intervention against headache. | 10 minutes | |
Primary | Cognitive Function | Cognitive function will be assessed using Montreal Cognitive Assessment (MoCA) questionnaire. The total score ranges from 0 to 30 points. The MoCA is divided into 7 subscores: visuospatial/executive (5 points); naming (3 points); memory (5 points for delayed recall); attention (6 points); language (3 points); abstraction (2 points); and orientation (6 points). One point is added if the subject has =12 years of education. A total of 30 points may be given. A score =25 indicates some degree of cognitive impairment. | 10 minutes | |
Primary | Depression | Depression will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0-21. A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a depressive state (borderline abnormal). A score of 11-21 points indicates a probable presence of a depressive state (abnormal). |
10 minutes | |
Primary | Anxiety | Anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0-21. A score of 0-7 points is regarded as being in the normal range. A score of 8-10 points is suggestive of a state of anxiety (borderline abnormal). A score of 11-21 points indicates a probable presence of an anxiety disorder (abnormal). |
10 minutes | |
Primary | Allodynia | Allodynia will be assessed using Allodynia Symptom Checklist (ASC-12) questionnaire. The total score ranges from 0-24 points. A score of 0-2 suggests no allodynia. A score of 3-5 suggests mild allodynia. A score of 6-8 suggests moderate allodynia. A score of 9 or more suggests severe allodynia. |
10 minutes | |
Primary | Post-Traumatic Stress Disorder | Post-traumatic stress disorder will be assessed using Harvard Trauma Questionnaire (HTQ). The total score ranges from 16-64. The total score is divided with 16 and a clinical cut-off score of 2.5 is set to be indicative of PTSD. | 10 minutes | |
Primary | Quality of Sleep: Pittsburgh Sleep Quality Index (PSQ-I) | Quality of Sleep will be assessed using Pittsburgh Sleep Quality Index (PSQ-I). The measure consists of 19 individual items, creating 7 components that produce one global score. The total PSQ-I score ranges from 0 to 21 with lower scores indicating a healthier sleep quality. | 10 minutes | |
Primary | Muscle Tenderness | Muscle tenderness will be assessed using Total Tenderness Score (TTS). The total score ranges from 0-48 with higher scores indicating a higher degree of muscle tenderness. | 10 minutes | |
Primary | Pressure Pain Threshold | Pressure Pain Threshold will be assessed using an Algometer. | 10 minutes | |
Primary | Cortical Density | Cortical density will be assessed using Voxel-Based Morphometry. | 10 minutes | |
Primary | Cortical Thickness | Cortical thickness will be assessed using Surface-Based Morphometry | 10 minutes | |
Primary | Number and Location of Microhemorrhages | The number and location of microhemorrhages will be assessed using Susceptibility-Weighted Imaging. | 6 minutes | |
Primary | White Matter Structural Fiber Integrity | The white matter structural fiber integrity will be assessed using Diffusion Tensor Imaging | 10 minutes | |
Primary | Number and Location of White Matter Lesions | The number and location of white matter lesions will be assessed using T2-weighted Fluid-Attenuated Inversion Recovery. | 6 minutes | |
Primary | Cerebral Blood Flow | Cerebral blood flow will be assessed using arterial spin labelling (ASL). | 7 minutes | |
Primary | Brain Network Functional Connectivity | Brain network functional connectivity will be assessed using blood oxygen level-dependent functional magnetic resonance imaging. | 11 minutes | |
Primary | Incidence of Headache Exacerbation with Migraine-Like Features | Migraine-like features are defined as headache fulfilling at least two of the following four characteristics: Unilateral location Pulsating quality Moderate or severe pain intensity Aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) And during headache at least one of the following must be fulfilled: Nausea and/or vomiting Photophobia and phonophobia Headache mimicking the usual exacerbated headache with migraine-like features If the participant fulfills these criteria at baseline, then incidence of exacerbated headache with migraine-like features is defined as: - An increase in headache intensity combined with an increase in the degree nausea and/or photophobia and phonophobia (based on a mild / moderate / severe scale) |
60 minutes | |
Primary | Headache Area under the Curve | Headache area under the curve is defined as headache intensity x duration up to 12 h after CGRP infusion | 12 hours | |
Primary | Time to Maximum Headache | Time to maximum headache score on CGRP day compared to placebo day will be assessed using a headache questionnaire | 12 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05849064 -
Concussion Treatment in Older Adults
|
N/A | |
Terminated |
NCT04586179 -
A Comparison Between Cardiovascular Exercise Modes Following Sport Related Concussion
|
N/A | |
Not yet recruiting |
NCT05943561 -
Biomarkers in Concussion
|
||
Completed |
NCT02721537 -
Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes
|
N/A | |
Completed |
NCT03236389 -
Brain Dynamics in Response to Jugular Vein Compression
|
N/A | |
Completed |
NCT01832714 -
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
|
||
Completed |
NCT04560400 -
Reverse King-Devick Test and History of Multiple Concussions
|
N/A | |
Completed |
NCT03678077 -
Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
|
||
Recruiting |
NCT05262361 -
Persistent Post-Concussion Symptoms With Convergence Insufficiency
|
N/A | |
Recruiting |
NCT05105802 -
Mindfulness-Based Intervention for Mild Traumatic Brain Injury
|
N/A | |
Terminated |
NCT03123822 -
Spectacles Lens in Concussed Kids
|
N/A | |
Completed |
NCT04641832 -
The Combined Effect of Chronic Cannabis Use and Subconcussive Head Impacts on Brain Health
|
N/A | |
Completed |
NCT04074486 -
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
|
||
Withdrawn |
NCT04578743 -
Exercise as Concussion Therapy Trial- 2
|
Phase 2 | |
Completed |
NCT03170856 -
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
|
N/A | |
Completed |
NCT03671083 -
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
|
||
Completed |
NCT05069948 -
Delivery of Digital Cognitive Behavioural Therapy Following Concussion
|
N/A | |
Recruiting |
NCT03889483 -
Neurophysiological Measurements Using the NeuroCatchâ„¢ Platform in Pediatric Concussion
|
N/A | |
Withdrawn |
NCT02959294 -
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
|
Early Phase 1 | |
Recruiting |
NCT06093295 -
Non-invasive Brain Stimulation and Injury Risk Biomechanics
|
N/A |