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Completed

NCT Number: NCT02881775

Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ≤ 5.
  • opposite knee does not have a diagnosis of knee osteoarthritis

Exclusion criteria

  • 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

Treatment and study plan

rTMS and exercise

Device

rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)

Other names: repetitive TMS

Sham rTMS and exercise

Device

rTMS unit is on and running but mu metal is placed between the coil and the skull

Other names: sham repetitive TMS

Primary outcomes

  1. Quadriceps Central Activation Ratio (CAR)

    Time frame: 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.

  2. Quadriceps Maximal Voluntary Isometric Contraction (MVIC)

    Time frame: 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).

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS) Score

    Time frame: Within 1 hour post intervention

    Pain intensity is rated on a visual analog scale of 0-10 where 0 is no pain and 10 is maximum pain

  2. Pressure Pain Threshold (PPT) - Medial Knee

    Time frame: Within 1 hour post intervention

    Using the AlgoMed algometer, pressure at a rate of 35 kPA/second is applied to the medial knee to the level that subject indicates is painful. Units of measure are kilopascal (kPa)

  3. Timed Up & Go (TUG)

    Time frame: Within 1 hour post intervention

    Time in seconds to rise from a chair, walk 3 m, return and sit down

  4. Active Motor Threshold Motor Evoked Potential (AMT-MEP)

    Time frame: Within 1 hour post intervention

    The quadriceps active muscle responses (motor evoked potentials) that result from the single-pulse transcranial magnetic stimulation (TMS) pulses over the motor cortex. These AMT-MEP are measured peak-to-peak in microvolts (uV ). 10 AMT-MEP values were collected and averaged.

  5. Short Interval Cortical Inhibition (SICI)

    Time frame: Within 1 hour post intervention

    Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 3 ms interval, will be used. SICI is the ratio of the conditioning stimulus relative to the test stimulus. A ratio < 1.0 indicates inhibition.

  6. Intra Cortical Facilitation (ICF)

    Time frame: Within 1 hour post intervention

    Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 15 ms interval, will be used. ICF is the ratio of the conditioning stimulus relative to the test stimulus. A ratio > 1.0 indicates facilitation.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute

Registry information

Official study title

Immediate Effects of rTMS on Corticospinal Excitability of the Quadriceps in People With Knee Osteoarthritis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2016
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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