Reuth Rehabilitation Hospital
Tel Aviv, Israel
Location status: Recruiting
Location contact
Gali Pinsky, BPT
CONTACT
Keren Sivan-Speier, MD
PRINCIPAL_INVESTIGATOR
Yotam Yanai, BPT
CONTACT
NCT Number: NCT07166536
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Tel Aviv, Israel
Location status: Recruiting
Gali Pinsky, BPT
CONTACT
Keren Sivan-Speier, MD
PRINCIPAL_INVESTIGATOR
Yotam Yanai, BPT
CONTACT
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 will be contacted by phone and given an extensive overview of the study. They will be invited to participate in the study, and will have to arive to Reuth Rehabilitation Hospital in Tel Aviv in order to sign an informed cosent form in front of a physician that will give them an additional explanation about the study and will answer all their questions and conserns. Current patients of Reut Rehabilitation Hospital will be invited to attend research sessions during their regular treatment days. Patients who have been discharged from the hospital will be invited to participate in research sessions at their convenience, with the option to schedule the first session shortly after signing the informed consent form.
Phase 3 - Medical Record Data Collection Data extraction from patients' medical records, including demographic information, injury date and mechanism, physical and cognitive consequences, additional symptoms, imaging findings, medical history, medication use, previous treatments, and social, psychological, or psychiatric status.
Phase 4 - Clinical Assessments Assessment Session 1
Assessment Session 2
Assessment Session 3
Phase 5 - Study Completion
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Withdrawal Criteria:
Time frame: Immediately before and after the intervention at assessment session 2
Measured on a 100mm Visual Analog Scale from 0 ("no Pain") to 100 ("most severe Pain")
Time frame: Immediately before and after the intervention at assessment session 2
Measured on a 100mm Visual Analog Scale from 0 ("no dizziness") to 100 ("most severe dizziness")
Time frame: Within 1-2 weeks before the intervention
Headache Impact Test-6 (HIT-6): A brief assessment tool used to measure the impact of headaches on daily life. The questionnaire includes six questions addressing the frequency of functional impairment, pain intensity, and quality of life related to headaches
Time frame: Within 1-2 weeks before the intervention
Rivermead Post-Concussion Symptoms Questionnaire (RPQ): A questionnaire assessing the severity of post-concussion symptoms. It includes 16 items where participants rate their symptoms compared to their pre-injury state on a Likert scale from 0 ("not experienced at all") to 4 ("severe problem").
Time frame: Within 1-2 weeks before the intervention
Dizziness Handicap Inventory (DHI): A questionnaire assessing the level of disability caused by dizziness. It consists of 25 items and provides a score in percentages, where 100% indicates a high level of perceived self-disability.
Time frame: Within 1-2 weeks before the intervention
Pain Catastrophizing Scale - A questionnaire assessing catastrophic thoughts related to pain, consisting of 13 items rated on a scale from 0 ("Never") to 4 ("Very much"). A high score indicates a tendency toward catastrophizing-exaggerated negative thoughts, helplessness, and magnification in response to pain.
Time frame: Within 1-2 weeks before the intervention
Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire assessing anxiety (HADS-A) and depression (HADS-D) in medical patients. Each subscale consists of 7 items rated on a 0-3 Likert scale, with total scores ranging from 0 to 21, where higher scores indicate greater symptom severity.
Time frame: Within 1-2 weeks before the intervention
Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire assessing anxiety (HADS-A) and depression (HADS-D) in medical patients. Each subscale consists of 7 items rated on a 0-3 Likert scale, with total scores ranging from 0 to 21, where higher scores indicate greater symptom severity.
Time frame: Within 1-2 weeks before the intervention
Positive and Negative Affect Schedule (PANAS): A questionnaire assessing positive and negative emotions, consisting of 20 items divided into two subscales: positive affect and negative affect. Participants rate the intensity of emotions they experienced over a specified period on a Likert scale from 1 ("Not at all") to 5 ("Very much").
Time frame: Within 1-2 weeks before the intervention
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5): A questionnaire assessing PTSD symptoms, including 20 items where participants rate symptom severity on a Likert scale from 0 ("Not at all") to 4 ("Very much").
Time frame: Within 1-2 weeks before the intervention
Somatization subscale of the Symptom Checklist-90-Revised (SCL-90-R): A questionnaire that assesses the presence and severity of somatic symptoms. It includes 12 items related to physical complaints such as pain, gastrointestinal issues, and cardiopulmonary symptoms. Each item is rated on a 0-4 Likert scale, with higher scores indicating greater levels of somatization.
Contact information is provided by the study sponsor or research team.
Gali Pinsky, BPT
CONTACT
Yotam Yanai, BPT
CONTACT
Reuth Rehabilitation Hospital
Other
Characterization of Headache and Dizziness Exacerbation Following Mental Imagery in Patients With Persistent Post-Concussive Symptoms
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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