Synergistic Effects of Neurotoxin and Physical Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
研究概览
简要总结
This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than Botox alone. It is also expected that Botox combined with Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox injection.
详细描述
The study will recruit primary cervical dystonia patients (age 18-80) who are stable on Allergan botulinum toxin type A (Botox). Patients will be randomized to receive their typical Botox injection alone, or with physical therapy.
At Baseline, disease characteristics (as measured by the Toronto Western Spasmodic Torticollis Rating Scale, or TWSTRS, and the Clinical Global Impression of Severity, or CGIS) will be measured, along with quality of life (from the Short Health 36 Survey Form 36, or SF-36). One subscale of the TWSTRS will be videotaped to be later evaluated by blinded movement disorder specialists. A pain scale will also be completed and range of head motion will be measured using a device similar to a protractor (called a goniometer). An individualized Botox injection will be administered, as well as transcranial magnetic stimulation (TMS) to measure neuroplasticity, or the ability of the brain to make new connections. If randomized to receive physical therapy, participants will also receive instructions to perform physical therapy exercises five times per week by a physical therapist who specializes in movement disorders. The investigator will call weekly to check how the participant is doing with the exercise program.
The same procedures outlined above will also be performed at 5 weeks past baseline, and at 12 weeks (except for the Botox injection, which will only be given at baseline and 12 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a movement disorders specialist
- •Positive response to at least two prior treatments with Botox as indicated by an improvement in Clinical Global Improvement Scale.
- •Received last dose of Botox a minimum of 12 weeks prior to baseline visit.
排除标准
- •Any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy)
- •Any secondary, fixed, post-traumatic, or psychogenic dystonia
研究组 & 干预措施
Botox only
Participants randomized to receive Botox injections alone.
干预措施: Botox injection (Drug)
Botox only
Participants randomized to receive Botox injections alone.
干预措施: Transcranial magnetic stimulation (TMS) (Procedure)
Botox plus Physical Therapy
Participants randomized to receive Botox injection combined with Physical Therapy
干预措施: Botox injection (Drug)
Botox plus Physical Therapy
Participants randomized to receive Botox injection combined with Physical Therapy
干预措施: Physical Therapy (Behavioral)
Botox plus Physical Therapy
Participants randomized to receive Botox injection combined with Physical Therapy
干预措施: Transcranial magnetic stimulation (TMS) (Procedure)
结局指标
主要结局
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
时间窗: absolute value at Week 12
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is a measure of symptoms, pain, and disability related to Cervical Dystonia. The total TWSTRS scale includes a global outcome score (total score) and scores on each of 3 subscales for severity (0-35), disability (0-30), and pain (0-20), which are summed together for a total score (0-85), with higher scores indicating greater impairment. The TWSTRS is completed by a neurologist who visually assesses the patient's symptoms, and asks the patient to self-report on pain and disability.
SF-36 Physical Functioning Subscore
时间窗: absolute value at Week 12
The Short Form 36-Item Health Scale (SF-36) is a health survey with 36 questions that is self-reported by the study participant. It contains 8 subscales, one of which is Physical Functioning, calculated from 10 of the 36 questions. Different questions have different score ranges and valences. Therefore, their response for each question is linearly transformed to a value of 0-100 (for example, choosing response 3 on a scale of 1-5 is transformed to 60). These ten values are then averaged to generate the Physical Functioning subscore, ranging from 0-100. The higher the response value and the subscore, the higher degree of physical functioning. More details on RAND SF-36 scoring here: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html
Clinical Global Impression Scale (CGIS)
时间窗: absolute value at Week 12
This scale is an investigator-rated scale that measures illness severity on a single 7-point scale (1-7). Higher scores represent greater severity of illness.
次要结局
- Mean MEP After Paired Associative Stimulation (PASmean)(absolute value at week 12)