Immediate Effects of rTMS on Corticospinal Excitability of the Quadriceps in People With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quadriceps Maximal Voluntary Isometric Contraction (MVIC)
研究概览
简要总结
The purpose of the study is to identify things that influence the ability to "turn on" the thigh muscle (quadriceps). The thigh muscle tends to be under active with knee osteoarthritis, which may make it difficult to strengthen the muscle. The investigators are also testing a new technology called repetitive transcranial magnetic stimulation (rTMS) to determine whether it may help "turn up" activity in the under active thigh muscle immediately after its application. rTMS uses a targeted pulsed magnetic field, similar to what is used in an MRI (magnetic resonance imaging) machine to send an electrical signal from the brain to the thigh muscle.
详细描述
The investigators will recruit up to 20 people with symptomatic knee osteoarthritis. The 20 eligible participants will attend 3 sessions in the laboratory. Session 1 is to collect data for Aim 1. Sessions 2 and 3 will include the rTMS interventions and data collection for Aim 2.
Aim 1 is a descriptive study to compare the neural (cortical and corticospinal) excitability of the quadriceps in the symptomatic knee to the asymptomatic knee in participants with knee osteoarthritis. The investigators will examine the associations between neural excitability and clinical measures of pain, strength, function, and coping styles.
Aim 2 is a double blind, crossover study design. Each participant will partake in two testing sessions, spaced 1 week apart. The investigators will evaluate outcome measures prior to and following the "true" intervention versus the "sham" intervention. The true intervention is rTMS + exercise. The sham is sham rTMS + exercise. The primary outcome measures are quadriceps strength, as measured from a maximal isometric voluntary contraction, and quadriceps central activation ratio (CAR), as calculated from the torque values from the voluntary strength measurement and a brief, intense electrical stimulus. Secondary measures evaluate effects of the intervention on 1) clinical measures of pain and functional performance, 2) corticospinal excitability, and 3) intracortical inhibition and facilitation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic knee osteoarthritis primarily involving one leg based on Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 10 (out of 100 points, indicating most dysfunction)
- •diagnosis of knee osteoarthritis
- •opposite knee with WOMAC pain score ≤
- •opposite knee does not have a diagnosis of knee osteoarthritis
排除标准
- •conditions affecting the leg other than osteoarthritis
- •low blood pressure (< 90 systolic, 60 diastolic) or heart rate (< 60 beats per minute)
- •conditions that limit exercise tolerance such as a heart condition
- •pregnant or planning to become pregnant in the next 3 months
- •conditions that alter sensation and pain processing
- •BMI > 35
- •severe arthritis in both knees
- •history of leg or back surgery in the past year or knee replacement surgery;
- •injection in the knee joint in the past 4 weeks
- •requires an assistive device to walk
- •any contraindications for TMS or rTMS (seizures, metal implants in head, brain related conditions, brain injury, drug or alcohol withdrawal)
- •medications that lower seizure threshold
- •history of fainting spells (syncope) or low blood pressure
- •sleep deprived
- •inability to understand and repeat back directions regarding the study
研究组 & 干预措施
rTMS and exercise, then Sham rTMS and exercise
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
干预措施: rTMS and exercise (Device)
rTMS and exercise, then Sham rTMS and exercise
At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters.
干预措施: Sham rTMS and exercise (Device)
Sham rTMS and exercise, then rTMS and exercise
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
干预措施: rTMS and exercise (Device)
Sham rTMS and exercise, then rTMS and exercise
At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters.
干预措施: Sham rTMS and exercise (Device)
结局指标
主要结局
Quadriceps Maximal Voluntary Isometric Contraction (MVIC)
时间窗: Within 1 hour post intervention
HUMAC NORM electromechanical dynamometer is used to measure isometric torque generation in quadriceps muscle stabilized with 70 degrees of knee flexion. Units of measure are in Newton meters (Nm).
Quadriceps Central Activation Ratio (CAR)
时间窗: Within 1 hour post intervention
Quadriceps Central Activation Ratio (CAR) is a percentage of the amount of torque produced during the superimposed burst technique using maximal voluntary isometric contraction (MVIC) and superimposed burst torque. It is reported on a scale of 0 (worst) to 100% (best) activation.
次要结局
- Numeric Pain Rating Scale (NPRS) Score(Within 1 hour post intervention)
- Pressure Pain Threshold (PPT) - Medial Knee(Within 1 hour post intervention)
- Active Motor Threshold Motor Evoked Potential (AMT-MEP)(Within 1 hour post intervention)
- Timed Up & Go (TUG)(Within 1 hour post intervention)
- Short Interval Cortical Inhibition (SICI)(Within 1 hour post intervention)
- Intra Cortical Facilitation (ICF)(Within 1 hour post intervention)