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Conditioning Brain Responses to Improve Thigh Muscle Function After Anterior Cruciate Ligament Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injury

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Operant Conditioning

Control

Single Pulse Transcranial Magnetic Stimulation

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Quadriceps activation deficits, ACL, Surgery, Quadrcieps weakness, Operant conditioning, Cortical excitability

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

aged 18-45 years
suffered an acute, complete ACL rupture
have undergone ACL reconstructive surgery
willingness to participate in testing and follow-up as outlined in the protocol

Exclusion Criteria:

have suffered a previous ACL injury;
have undergone previous major surgery to either knee;
have a history of recent significant knee injury (other than ACL) or lower-extremity fracture;
have a history of uncontrolled diabetes or hypertension;
be pregnant or plan to become pregnant;
have metal implants in the head;
have electronic devices in their ear or heart (e.g., cochlear implants or cardiac pacemakers);
have unexplained recurrent headaches;
have a recent history of seizures;
be taking drugs that reduce seizure threshold;
have a history of repeated fainting spells;

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Operant Conditioning

Control

Arm Description

Participants will receive operant conditioning training and single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks.

Participants will receive single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks without operant conditioning training.

Outcomes

Primary Outcome Measures

Changes in Quadriceps muscle strength

Quadriceps strength will be measured using an isokinetic dynamometer. Improvements in quadriceps strength from baseline to the end of intervention will be assessed and compared between groups.

Secondary Outcome Measures

Changes in voluntary activation

Voluntary activation will be measured using an electrical superimposition technique. Improvements in voluntary activation from baseline to the end of intervention will be assessed and compared between groups.

Full Information

NCT ID

NCT03209531

First Posted

June 30, 2017

Last Updated

August 1, 2023

Sponsor

University of Michigan

Collaborators

Medical University of South Carolina, National Center of Neuromodulation for Rehabilitation

1. Study Identification

Unique Protocol Identification Number

NCT03209531

Brief Title

Conditioning Brain Responses to Improve Thigh Muscle Function After Anterior Cruciate Ligament Reconstruction

Official Title

Operant Conditioning of Motor Evoked Responses to Improve Quadriceps Function in Individuals With Anterior Cruciate Ligament Reconstruction

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 21, 2017 (Actual)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

Medical University of South Carolina, National Center of Neuromodulation for Rehabilitation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved through a form of mental coaching and encouragement, known as operant conditioning.

Detailed Description

Thigh muscle weakness is a common result after anterior cruciate ligament (ACL) injury and reconstruction surgery. Therefore, reducing thigh muscle weakness after ACL injury and reconstructive surgery is important as the quadriceps muscles act as shock absorbers that protect the knee joint. If significant weakness is present in the quadriceps, the knee is exposed to increased forces and often results in degeneration of the structures in the joint leading to osteoarthritis. Thus, it is important to investigate activation and strength rehabilitation methods for the quadriceps muscles. This research study is being done to learn if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury can be improved by conditioning brain responses (elicited by non-invasive transcranial magnetic stimulation) using a form of training called as operant conditioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Injury

Keywords

Quadriceps activation deficits, ACL, Surgery, Quadrcieps weakness, Operant conditioning, Cortical excitability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Operant Conditioning

Arm Type

Experimental

Arm Description

Participants will receive operant conditioning training and single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks.

Arm Title

Control

Arm Type

Experimental

Arm Description

Participants will receive single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks without operant conditioning training.

Intervention Type

Behavioral

Intervention Name(s)

Operant Conditioning

Intervention Description

Active encouragement and feedback to increase motor evoked response when stimulated.

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

Absence of active encouragement and feedback to increase motor evoked response when stimulated.

Intervention Type

Device

Intervention Name(s)

Single Pulse Transcranial Magnetic Stimulation

Intervention Description

Transcranial magnetic stimulation to elicit a motor evoked response from the quadriceps muscles.

Primary Outcome Measure Information:

Title

Changes in Quadriceps muscle strength

Description

Quadriceps strength will be measured using an isokinetic dynamometer. Improvements in quadriceps strength from baseline to the end of intervention will be assessed and compared between groups.

Time Frame

Approximately 8 weeks after the start of intervention

Secondary Outcome Measure Information:

Title

Changes in voluntary activation

Description

Time Frame

Approximately 8 weeks after the start of intervention

Other Pre-specified Outcome Measures:

Title

Changes in mid-point quadriceps muscle strength

Description

Quadriceps strength will be measured using an isokinetic dynamometer. Improvements in quadriceps strength from baseline to the mid-point of intervention will be assessed and compared between groups.

Time Frame

Approximately 4 weeks after the start of intervention (mid-time point evaluation)

Title

Changes in mid-point voluntary activation as measured by percentage activation deficit

Description

Voluntary activation will be measured using an electrical superimposition technique. Improvements in voluntary activation from baseline to the mid-point of intervention will be assessed and compared between groups.

Time Frame

Approximately 4 weeks after the start of intervention (mid-time point evaluation)

Title

Changes in motor cortical excitability measures

Description

Motor cortical excitability will be measured using single- and paired-pulse transcranial magnetic stimulation protocols. Improvements in motor cortical excitability from baseline to the end of intervention will be assessed and compared between groups.

Time Frame