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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881775
• Other study ID #: 16-0255
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 26, 2018

Study information

• Verified date: March 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• rTMS and exercise
rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)
• Sham rTMS and exercise
rTMS unit is on and running but mu metal is placed between the coil and the skull

Locations

Country	Name	City	State
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	North Carolina Translational and Clinical Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps Central Activation Ratio (CAR)	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.	Within 1 hour post intervention
Primary	Quadriceps Maximal Voluntary Isometric Contraction (MVIC)	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).	Within 1 hour post intervention
Secondary	Numeric Pain Rating Scale (NPRS) Score	Pain intensity is rated on a visual analog scale of 0-10 where 0 is no pain and 10 is maximum pain	Within 1 hour post intervention
Secondary	Pressure Pain Threshold (PPT) - Medial Knee	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)	Within 1 hour post intervention
Secondary	Timed Up & Go (TUG)	Time in seconds to rise from a chair, walk 3 m, return and sit down	Within 1 hour post intervention
Secondary	Active Motor Threshold Motor Evoked Potential (AMT-MEP)	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.	Within 1 hour post intervention
Secondary	Short Interval Cortical Inhibition (SICI)	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.	Within 1 hour post intervention
Secondary	Intra Cortical Facilitation (ICF)	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.	Within 1 hour post intervention