NCT07166536 Symptom Exacerbation Following Mental Imagery in Patients With Persistent Post-Concussive Symptoms
| NCT ID | NCT07166536 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Reuth Rehabilitation Hospital |
| Condition | Mild Traumatic Brain Injury, Concussion |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 their underlying mechanisms remain unclear. Predictive processing theories suggest that persistent symptoms may result from learned perceptual errors, particularly in individuals with high negative affectivity. This framework may help explain ongoing persistent post-concussive symptoms (PPCS) in the absence of identifiable pathology, which have been linked to various psychological factors. Mental imagery (MI) is thought to engage similar predictive processes. There is evidence that MI of symptom-triggering movements may exacerbate symptoms in individuals with chronic somatic conditions. However, this phenomenon has not been studied in PPCS patients. Investigating symptom provocation through MI may yield novel insights into the neuropsychological mechanisms sustaining PPCS and potentially contribute to the development of therapeutic tools for this population. Objectives: 1. Documenting the exacerbation of headache and dizziness following provocative mental imagery (imagery of movements or scenarios that elicit these symptoms in real life) in patients with PPCS. 2. Comparing changes in headache and dizziness after provocative MI versus neutral MI (imagery of movements or scenarios that do not elicit these symptoms in real life). 3. Comparing patients who experience symptom exacerbation following mental imagery to those who do not. 4. Describing associations between symptom exacerbation and negative affectivity, anxiety, depression, catastrophizing, and lower daily functioning. Methods: A cross-sectional study will be conducted on adult patients experiencing PPCS following mTBI. Participants will be recruited through convenience sampling from a computerized hospital database of Reuth Rehabilitation Hospital, based on inclusion and exclusion criteria. After signing an informed consent form, participants will be invited to attend 2 to 3 sessions, each lasting 1 to 2 hours. During these sessions, a licensed physiotherapist will conduct a comprehensive clinical assessment, including: Completion of self-report questionnaires; A vestibular examination; Anamnestic interview and clinical assessment of individual movement- and scenario-related triggers for dizziness and headaches; Symptom provocation testing using mental imagery of the identified triggers.
Eligibility Criteria
Inclusion Criteria: 1. Current patients of Reut Rehabilitation Hospital or individuals who were discharged from the hospital within the past 12 months. 2. Diagnosis of mild Traumatic Brain Injury, concussion, blast injury, or cervical whiplash injury. 3. More than 3 months since the event. 4. Presence of headaches and/or dizziness that began after the injury and have persisted continuously or intermittently. 5. Exclusion of other potential causes of headaches, such as non-healed fractures, chronic inflammation/infection, increased intracranial pressure, or meningeal injury. 6. Headache intensity of at least 3/10 on the VAS scale. Exclusion Criteria: 1. Significant cognitive impairment preventing informed consent (Mini-Mental State Examination score \<20 or Montreal Cognitive Assessment score \<20, as per IRB requirements). 2. Diagnosed central neurological conditions such as multiple sclerosis, Parkinson's disease, stroke, or brain tumor. 3. Presence of known pyramidal or extrapyramidal neurological signs. 4. Significant language impairment interfering with communication. 5. Psychiatric disorders significantly affecting communication. 6. 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.
Contact & Investigator
Keren Sivan-Speier, MD
PRINCIPAL INVESTIGATOR
Reuth Rehabilitation Hospital
Frequently Asked Questions
Who can join the NCT07166536 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Mild Traumatic Brain Injury, Concussion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07166536 currently recruiting?
Yes, NCT07166536 is actively recruiting participants. Contact the research team at yanayot@gmail.com for enrollment information.
Where is the NCT07166536 trial being conducted?
This trial is being conducted at Tel Aviv, Israel.
Who is sponsoring the NCT07166536 clinical trial?
NCT07166536 is sponsored by Reuth Rehabilitation Hospital. The principal investigator is Keren Sivan-Speier, MD at Reuth Rehabilitation Hospital. The trial plans to enroll 60 participants.