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Mild Traumatic Brain Injury, ConcussionNCT07166536

Effect of Mental Imagery in Patients With Persistent Post-concussion Symptoms

A study testing Provocation Test for Symptoms Using Mental Imagery in people with Mild Traumatic Brain Injury, Concussion and Post Concussive Syndrome, Chronic, run by Reuth Rehabilitation Hospital at 1 site in Israel.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
What is being tested?
Provocation Test for Symptoms Using Mental Imagery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteIsrael
Study dates
7 Sep 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yotam Yanai, BPT contact

972523993918

yanayot@gmail.com

Gali Pinsky, BPT contact

972546326566

galipinsky95@gmail.com

Israel1 site, 1 recruiting
  • Reuth Rehabilitation Hospital

    Tel Aviv

    Yotam Yanai, BPT, +972523993918, yanayot@gmail.com

    Gali Pinsky, BPT, +972546326566, galipinsky95@gmail.com

    Recruiting

Other trials in Israel

About this study

Official title: Effect of Mental Imagery on Headache and Dizziness in Patients With Persistent Post-concussion Symptoms

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.

Read more

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 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.

Read the 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 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

  • Cognitive screening test: In accordance with the Institutional Review Board (IRB) requirement, the Mini-Mental State Examination (MMSE) will be administered to provide a gross screening of cognitive status and to confirm eligibility for informed consent and study participation. Participants scoring <20 points will be excluded.
  • Completion of self-reported questionnaires, including demographic information, symptoms and triggers, concussion symptomatology, dizziness-related disability, headache impact, catastrophizing, PTSD levels, anxiety, depression, negative affectivity and somatization.
  • Vestibular and oculomotor assessment, including the Video Head-Impulse Test (vHIT) to rule out central and peripheral vestibular pathology, conducted by a certified vestibular physiotherapist.

Assessment Session 2

  • Completion of the vestibular assessment and questionnaires (if not completed in Session 1).
  • Symptom provocation test using mental imagery in a randomized order:
  • Movement mental imagery: Randomized sequence of 2 provocative movements and 2 neutral movements for each symptom (headache and/or dizziness).
  • Scenario mental imagery: Randomized sequence of 2 provocative scenarios and 2 neutral scenarios for each symptom (headache and/or dizziness).

Assessment Session 3

  • Completion of pending assessments.

Phase 5 - Study Completion

Being tested
Provocation Test for Symptoms Using Mental Imagery
Keywords
mild traumatic brain injury, Persistent Post-Concussion Symptoms, mental imagery, concussion
Medical subject headings
Brain Concussion, Post-Concussion Syndrome, Post-Traumatic Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Provocation Test for Symptoms Using Mental ImageryOther

    • 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..."
Study groups in NCT07166536
Study groupRoleWhat they receive
Mental Imagery Provocation TestingExperimentalProvocation 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.
Receives: Other: Provocation Test for Symptoms Using Mental Imagery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache intensity Change

    Measured on a 100mm Visual Analog Scale from 0 ("no Pain") to 100 ("most severe Pain")

    Measured: Immediately before and after the intervention at assessment session 2

  2. Dizziness intensity change

    Measured on a 100mm Visual Analog Scale from 0 ("no dizziness") to 100 ("most severe dizziness")

    Measured: Immediately before and after the intervention at assessment session 2

Secondary outcomes (9)
  1. 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

    Measured: Within 1-2 weeks before the intervention

  2. 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").

    Measured: Within 1-2 weeks before the intervention

  3. 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.

    Measured: Within 1-2 weeks before the intervention

  4. 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.

    Measured: Within 1-2 weeks before the intervention

  5. 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.

    Measured: Within 1-2 weeks before the intervention

  6. 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.

    Measured: Within 1-2 weeks before the intervention

  7. 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").

    Measured: Within 1-2 weeks before the intervention

  8. 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").

    Measured: Within 1-2 weeks before the intervention

  9. 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.

    Measured: Within 1-2 weeks before the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start7 Sep 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07166536
Sponsor's protocol ID
0003-25-RRH
Status last verified
Sep 2025
First submitted
3 Sep 2025
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Polinder S, Cnossen MC, Real RGL, Covic A, Gorbunova A, Voormolen DC, Master CL, Haagsma JA, Diaz-Arrastia R, von Steinbuechel N. A Multidimensional Approach to Post-concussion Symptoms in Mild Traumatic Brain Injury. Front Neurol. 2018 Dec 19;9:1113. doi: 10.3389/fneur.2018.01113. eCollection 2018.

    PubMed 30619066
  • de Neeling M, Liessens D, Depreitere B. Relationship between psychosocial and psychiatric risk factors and poor long-term outcome following mild traumatic brain injury: A systematic review. Eur J Neurol. 2023 May;30(5):1540-1550. doi: 10.1111/ene.15713. Epub 2023 Feb 15.

    PubMed 36708085
  • Dijkstra N, Bosch SE, van Gerven MAJ. Shared Neural Mechanisms of Visual Perception and Imagery. Trends Cogn Sci. 2019 May;23(5):423-434. doi: 10.1016/j.tics.2019.02.004. Epub 2019 Mar 12.

    PubMed 30876729
  • Van den Bergh O, Witthoft M, Petersen S, Brown RJ. Symptoms and the body: Taking the inferential leap. Neurosci Biobehav Rev. 2017 Mar;74(Pt A):185-203. doi: 10.1016/j.neubiorev.2017.01.015. Epub 2017 Jan 17.

    PubMed 28108416
  • Moseley GL, Zalucki N, Birklein F, Marinus J, van Hilten JJ, Luomajoki H. Thinking about movement hurts: the effect of motor imagery on pain and swelling in people with chronic arm pain. Arthritis Rheum. 2008 May 15;59(5):623-31. doi: 10.1002/art.23580.

    PubMed 18438892

Questions about this trial

What is this clinical trial studying?

A study testing Provocation Test for Symptoms Using Mental Imagery in people with Mild Traumatic Brain Injury, Concussion and Post Concussive Syndrome, Chronic, run by Reuth Rehabilitation Hospital at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yotam Yanai, BPT (972523993918, yanayot@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache intensity Change (time frame: Immediately before and after the intervention at assessment session 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07166536, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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