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Operant Conditioning for ACL Injury

N/A
Recruiting
Led By Chandramouli Krishnan, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suffered an acute, complete ACL rupture
Aged 18-45 years
Must not have
Have undergone previous major surgery to either knee
Be taking drugs that reduce seizure threshold
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 weeks after the start of intervention (mid-time point evaluation)
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if operant conditioning can improve thigh muscle weakness and lack of muscle activation after an ACL injury.

Who is the study for?
This trial is for individuals aged 18-45 who have had an ACL rupture and subsequent reconstructive surgery. Participants must be willing to follow the study's procedures. Those pregnant, with previous major knee surgeries, on certain drugs, with fainting spells, uncontrolled diabetes or hypertension, ear/heart devices, recurrent headaches, seizures or recent significant knee injuries cannot join.
What is being tested?
The study tests if thigh muscle weakness post-ACL injury can be improved using mental coaching (operant conditioning) alongside Single Pulse Transcranial Magnetic Stimulation versus a control group without these interventions.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site from Transcranial Magnetic Stimulation and fatigue due to participation in operant conditioning sessions. No severe side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a recent, complete tear in my ACL.
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I am between 18 and 45 years old.
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I have had ACL reconstructive surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had major surgery on one of my knees.
Select...
I am taking medication that could lower my seizure threshold.
Select...
I have diabetes or high blood pressure that is not well-controlled.
Select...
I often have headaches for no known reason.
Select...
I have had seizures recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 weeks after the start of intervention (mid-time point evaluation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 weeks after the start of intervention (mid-time point evaluation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Structure of quadriceps femoris muscle
Secondary study objectives
Changes in voluntary activation
Other study objectives
Changes in International Knee Documentation Committee Score
Changes in Knee Injury and Osteoarthritis Outcome Score
Changes in Lysholm Knee Score
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Operant ConditioningExperimental Treatment2 Interventions
Participants will receive operant conditioning training and single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks.
Group II: ControlExperimental Treatment2 Interventions
Participants will receive single pulse transcranial magnetic stimulation 2-3 times a week for about 8 weeks without operant conditioning training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Operant Conditioning
2022
N/A
~30
Control
2011
Completed Phase 4
~15780

Find a Location

Who is running the clinical trial?

National Center of Neuromodulation for RehabilitationUNKNOWN
11 Previous Clinical Trials
228 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,067 Previous Clinical Trials
2,747,432 Total Patients Enrolled
3 Trials studying Anterior Cruciate Ligament Injury
183 Patients Enrolled for Anterior Cruciate Ligament Injury
Medical University of South CarolinaOTHER
979 Previous Clinical Trials
7,400,953 Total Patients Enrolled
University of MichiganLead Sponsor
1,863 Previous Clinical Trials
6,441,561 Total Patients Enrolled
4 Trials studying Anterior Cruciate Ligament Injury
250 Patients Enrolled for Anterior Cruciate Ligament Injury
Chandramouli Krishnan, PhDPrincipal Investigator - Assistant Professor
University of Michigan
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
30 Patients Enrolled for Anterior Cruciate Ligament Injury

Media Library

Operant Conditioning (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03209531 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Control, Operant Conditioning
Anterior Cruciate Ligament Injury Clinical Trial 2023: Operant Conditioning Highlights & Side Effects. Trial Name: NCT03209531 — N/A
Operant Conditioning (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03209531 — N/A
~2 spots leftby Sep 2026
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