Effect of Mental Imagery on Headache and Dizziness in Patients With Persistent Post-concussion Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dizziness intensity change
研究概览
简要总结
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:
- 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.
- 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).
- Comparing patients who experience symptom exacerbation following mental imagery to those who do not.
- 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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mental Imagery Provocation Testing
Provocation Test for Symptoms Using Mental Imagery:
- Baseline symptom intensity (dizziness/headache) will be measured using the VAS scale.
- Instruction to perform the movement that is hypothesized to provoke the symptom in reality for approximately 10-20 seconds
- Measurement of symptom intensity using the VAS scale following the provoked movement.
- Rest period of several minutes.
- Measurement of symptom intensity following rest using the VAS scale.
- Instruction to mentally imagine the movement or scenario hypothesized to provoke the symptom in reality for approximately 10-20 seconds
- Measurement of symptom intensity using the VAS scale following mental imagery.
- Measurement of imagery vividness using the VAS-V scale.
干预措施: Provocation Test for Symptoms Using Mental Imagery (Other)
结局指标
主要结局
Dizziness intensity change
时间窗: 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")
Headache intensity Change
时间窗: 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")
次要结局
- Headache Impact on Daily life(Within 1-2 weeks before the intervention)
- Post-Concussion Symptoms(Within 1-2 weeks before the intervention)
- Perceived disability due to dizziness(Within 1-2 weeks before the intervention)
- Pain Catastrophizing(Within 1-2 weeks before the intervention)
- Anxiety(Within 1-2 weeks before the intervention)
- Depression(Within 1-2 weeks before the intervention)
- Positive and Negative Affect(Within 1-2 weeks before the intervention)
- PTSD symptom levels(Within 1-2 weeks before the intervention)
- Somatization(Within 1-2 weeks before the intervention)