An interventional study of Provocation Test for Symptoms Using Mental Imagery in Mild Traumatic Brain Injury, Concussion, Post Concussive Syndrome, Chronic and Post Traumatic Headache, sponsored by Reuth Rehabilitation Hospital. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Reuth Rehabilitation Hospital · Not applicable, Interventional, and Other
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:
Methods: A single-group, open-label experimental provocation study is being conducted in adult patients with persistent post-concussive symptoms following mild traumatic brain injury. Each participant undergoes all imagery conditions, with the order of provocative and neutral mental imagery stimuli randomized within participants. Participants are recruited by convenience sampling from the computerized patient database of Reuth Rehabilitation Hospital according to the 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.
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
Symptom provocation test using mental imagery in a randomized order:
Assessment Session 3
Phase 5 - Study Completion
141 studies on the registry are indexed under Post-Concussion Syndrome; 34 are open to participants now.
This study's planned enrollment of 60 is above the median of 52 across 114 interventional studies indexed under Post-Concussion Syndrome.
Browse Post-Concussion Syndrome studies →Reuth Rehabilitation Hospital is the lead sponsor of 16 studies on the registry; 5 are open to participants now.
Compared within Post-Concussion Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Concussion. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Withdrawal Criteria:
1. Oculomotor dysfunction affecting multiple oculomotor functions.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Provocation Test for Symptoms Using Mental Imagery: 1. Baseline symptom intensity (dizziness/headache) will be measured using the VAS scale. 2. Instruction to perform the movement that is hypothesized to provoke the symptom in reality for approximately 10-20 seconds 3. Measurement of symptom intensity using the VAS scale following the provoked movement. 4. Rest period of several minutes. 5. Measurement of symptom intensity following rest using the VAS scale. 6. Instruction to mentally imagine the movement or scenario hypothesized to provoke the symptom in reality for approximately 10-20 seconds 7. Measurement of symptom intensity using the VAS scale following mental imagery. 8. Measurement of imagery vividness using the VAS-V scale.
Other: Provocation Test for Symptoms Using Mental Imagery
• The mental imagery task will be guided by the examiner through continuous verbal instruction (the examiner will provide ongoing instructions throughout the entire task, not just at the beginning). During the instruction, the examiner will direct the participant's attention to visual, auditory, and proprioceptive aspects of the imagined movement or scenario. Example: "Close your eyes, and without moving your head or body at all, try to imagine that you are moving your head from side to side quickly and easily, while noticing the sensation of motion, seeing the rotation through your eyes, and feeling the acceleration of your head as it moves from side to side..."
Headache intensity Change
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
Dizziness intensity change
Measured on a 100mm Visual Analog Scale from 0 ("no dizziness") to 100 ("most severe dizziness")
Time frame: Immediately before and after the intervention at assessment session 2
Headache Impact on Daily life
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
Post-Concussion Symptoms
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
Perceived disability due to dizziness
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
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
Anxiety
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
Depression
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
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
PTSD symptom levels
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
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.
Time frame: Within 1-2 weeks before the intervention
Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.
Of 54 non-industry interventional studies with no phase under Post-Concussion Syndrome, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's planned 15 months is below that.
Counting every sponsor, half of 56 studies reached it within 40 months; a quarter within 23 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Reuth Rehabilitation Hospital