NCT02881775

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 29, 2019

Completed
Last Updated

June 11, 2019

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

August 15, 2016

Results QC Date

May 2, 2019

Last Update Submit

May 28, 2019

Conditions

Osteoarthritis, Knee

Keywords

TMSrTMScorticospinalquadriceps

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Numeric Pain Rating Scale (NPRS) Score

    Within 1 hour post intervention

  • Pressure Pain Threshold (PPT) - Medial Knee

    Within 1 hour post intervention

  • Timed Up & Go (TUG)

    Within 1 hour post intervention

  • Active Motor Threshold Motor Evoked Potential (AMT-MEP)

    Within 1 hour post intervention

  • Short Interval Cortical Inhibition (SICI)

    Within 1 hour post intervention

  • +1 more secondary outcomes

Study Arms (2)

rTMS and exercise, then Sham rTMS and exercise

EXPERIMENTAL

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.

Device: rTMS and exerciseDevice: Sham rTMS and exercise

Sham rTMS and exercise, then rTMS and exercise

SHAM COMPARATOR

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.

Device: rTMS and exerciseDevice: Sham rTMS and exercise

Interventions

rTMS and exerciseDEVICE

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

Also known as: repetitive TMS
Sham rTMS and exercise, then rTMS and exerciserTMS and exercise, then Sham rTMS and exercise
Sham rTMS and exerciseDEVICE

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

Also known as: sham repetitive TMS
Sham rTMS and exercise, then rTMS and exerciserTMS and exercise, then Sham rTMS and exercise

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcranial Magnetic StimulationExercise Therapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Results Point of Contact

Title
Deborah Givens, PhD
Organization
University of North Carolina at Chapel Hill
deborah_givens@med.unc.edu
919-843-8660

Study Officials

  • Deborah L Givens, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 29, 2016

Study Start

September 1, 2016

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

June 11, 2019

Results First Posted

May 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)