Status:
NOT_YET_RECRUITING
Symptom Exacerbation Following Mental Imagery in Patients With Persistent Post-Concussive Symptoms
Lead Sponsor:
Reuth Rehabilitation Hospital
Conditions:
Mild Traumatic Brain Injury, Concussion
Post Concussive Syndrome, Chronic
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Background: Mild Traumatic Brain Injury (mTBI) often results in persistent emotional, cognitive, and somatic symptoms-such as headaches and dizziness. These symptoms impose a significant burden, yet t...
Detailed Description
Study Procedure Phase 1 - Recruitment A sample will be drawn from the hospital's computerized database based on the inclusion and exclusion criteria. Phase 2 - Patient Enrollment Potential patients ...
Eligibility Criteria
Inclusion
- Current patients of Reut Rehabilitation Hospital or individuals who were discharged from the hospital within the past 12 months.
- Diagnosis of mild Traumatic Brain Injury, concussion, blast injury, or cervical whiplash injury.
- More than 3 months since the event.
- Presence of headaches and/or dizziness that began after the injury and have persisted continuously or intermittently.
- Exclusion of other potential causes of headaches, such as non-healed fractures, chronic inflammation/infection, increased intracranial pressure, or meningeal injury.
- Headache intensity of at least 3/10 on the VAS scale.
Exclusion
- Significant cognitive impairment preventing informed consent (Mini-Mental State Examination score \<20 or Montreal Cognitive Assessment score \<20, as per IRB requirements).
- Diagnosed central neurological conditions such as multiple sclerosis, Parkinson's disease, stroke, or brain tumor.
- Presence of known pyramidal or extrapyramidal neurological signs.
- Significant language impairment interfering with communication.
- Psychiatric disorders significantly affecting communication.
- Use of vestibular-suppressant medication (e.g., Cinnarizine) with an inability or unwillingness to discontinue treatment 24 hours prior to testing.
- Withdrawal Criteria:
- 1\. Oculomotor dysfunction affecting multiple oculomotor functions.
Key Trial Info
Start Date :
September 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07166536
Start Date
September 7 2025
End Date
December 31 2026
Last Update
September 10 2025
Active Locations (1)
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1
Reuth Rehabilitation Hospital
Tel Aviv, Israel