Effectiveness of Targeted Individualized Multi-modal Treatments in Adults Suffering From Persistent Concussion Symptoms as Compared to Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rivermead Postconcussion Questionnaire
研究概览
简要总结
Protocol Summary
The present study was developed to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control. The secondary aim is to evaluate the Pre and Post treatment state of the participants via a rapid advanced electroencephalography (EEG) when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The EEG changes will be compared to the standardized clinical examination findings as well as the RPQ.
Sample Size:
N= 50
Study Population
Participants will be eligible for study participation if they meet the following inclusion criteria: 21-years and older; diagnosed with postconcussion syndrome; and have adequate language skills in English to read and take part in rehabilitation treatment program. Participants will be excluded should: they have an unremarkable or normal clinical examination; have a chronic infectious disease; uncontrolled hypertension; other neurological disorders (not attributed to their primary diagnosis); cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities; those with pacemakers or elevated cardiovascular risk; ongoing litigation surrounding their injury; have been diagnosed with a moderate or severe brain injury prior to enrolment; post-concussive symptoms persisting beyond 12-months.
Study Design
The investigators will be conducting a 12-week case-crossover randomized controlled trial. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6-weeks. At the end of 12-weeks, participants will undertake the endpoint examinations.
Start Date:
May 2023
End Date:
September 2025
Primary Objective:
The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control.
详细描述
Background and Rationale
Disabilities secondary to traumatic brain injury are a major source of burden. Numerous treatments have been utilized and studied in an attempt to treat persistent postconcussive symptoms. However, the majority of clinical trials examined the efficacy of a single treatment. Given mild traumatic brain injury (mTBI) is a heterogenous condition characterized by a variety of clinical presentations, one could assume a lack of recovery or response to therapy when done in isolation.
The present study was developed to better understand the effects of individualized rehabilitative care in concussion patients. Specifically, the investigators seek to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The investigators' intention is to establish a treatment methodology based on subgroup classification to individualized rehabilitative treatment programs. The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control. The secondary aim is to evaluate the Pre and Post treatment state of the participants via a rapid advanced EEG when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The electrophysiological changes will be compared to the standardized clinical examination findings as well as the RPQ.
Hypothesis
The investigators hypothesize that participants suffering from persistent post-concussive symptoms, with dominant somatic features, undergoing an individualized rehabilitation program derived from subgroup classification will demonstrate clinically meaningful and statistically significant improved RPQ scores when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. Additionally, the investigators expect significantly improved brain vital sign as measured by rapid EEG, which will serve as a biomarker to confirm the clinical changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21-years and older
- •meet the definition of postconcussion syndrome, which requires a participant to report any 3 symptoms or more (from an inclusive list of 40 most commonly reported persisting symptoms) lasting at least 1-month following the diagnosis of a concussion. Concussion was defined according to the 5th International Consensus Statement on Concussion in Sport.
- •Have adequate language skills in English to read and take part in rehabilitation treatment program.
排除标准
- •In-patients at Toronto Rehabilitation Institute or any other affiliated University Health Network clinics.
- •Participants will be excluded should their clinical examination be unremarkable for objective physical impairments,
- •Have a chronic infectious disease,
- •Uncontrolled hypertension,
- •Other neurological disorders (not attributed to their primary diagnosis),
- •Cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities, those with pacemakers or elevated cardiovascular risk,
- •Ongoing litigation surrounding their injury,
- •Have been diagnosed with a moderate or severe brain injury prior to enrolment, post-concussive symptoms persisting beyond 12-months.
结局指标
主要结局
Rivermead Postconcussion Questionnaire
时间窗: Baseline; 6-weeks; 12-weeks
The Rivermead Post-Concussion Symptom Questionnaire (RPQ) is a self-report scale to measure the severity of post-concussive symptoms following a Traumatic Brain Injury (TBI). Each item is rated on a 5-point ordinal scale: 0 = not experienced at all, 1 = no more of a problem, 2 = a mild problem, 3 = a moderate problem, and 4 = a severe problem. The total score is a sum of all items and ranges from 0 to 64 from (best to worst).
次要结局
- Neck Disability Index (NDI)(Baseline; 6-weeks; 12-weeks)
- Brain Vital Sign(Baseline; 6-weeks; 12-weeks)
- Patient Health Questionnaire (PHQ-9)(Baseline; 6-weeks; 12-weeks)