NCT07020312 Brain-Computer Interface Visualization Training to Optimize Muscle Activation Following Orthopaedic Surgery
| NCT ID | NCT07020312 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rush University Medical Center |
| Condition | Anterior Cruciate Ligament Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-08-14 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2025-08-14 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
After orthopedic surgeries like knee or hip replacement, some patients struggle to fully activate their muscles due to a condition called Arthrogenic Muscle Inhibition (AMI). AMI can slow recovery and make physical therapy less effective. This clinical trial is testing whether a special type of brain training-called neurofeedback visualization training-can help improve muscle activation and speed up recovery. In this study, patients will receive standard physical therapy after surgery. Half of them will also use a device that helps them "visualize" exercises while wearing a cap that reads brain signals (EEG). The cap tracks brain activity when patients imagine doing specific movements. A computer then shows a virtual avatar performing the movements, giving feedback in real time-like a video game controlled by the brain. The study includes patients recovering from one of four surgeries: 1. Anterior cruciate ligament reconstruction (ACLR) 2. Total knee arthroplasty (TKA) 3. Total hip arthroplasty (THA) 4. Hip arthroscopy (HA) for femoroacetabular impingement (FAI) The goal is to see if this training improves muscle strength, movement, and daily function more than standard therapy alone. The study will take place at Rush University Medical Center in Chicago and enroll 240 adults, with 60 patients per type of surgery. Each participant will be followed for up to 6 months after surgery and complete strength tests, movement assessments, and questionnaires about their recovery. The hope is that combining brain training with physical therapy will lead to faster, more complete recoveries and improve how patients move after surgery.
Eligibility Criteria
Participants * Inclusion Criteria: * Patient age \>18 years * Ability to complete neurofeedback training and follow study follow-ups * Indicated for one of the four investigated orthopedic procedures * Exclusion Criteria: * Inability to participate in neurofeedback training * Lack of decisional capability * History of stroke, movement disorder (e.g. Parkinson's), peripheral neuropathy * Cardiac pacemaker or other internal electronic device * BMI \>35 * Previous surgery or specific pathology on the affected joint (refer to procedure specific indications below) Procedure Specifics: Anterior cruciate ligament reconstruction (ACLR) Procedure-specific Inclusion Criteria * Patients undergoing primary ACLR with autograft or allograft tissue * Adjunct lateral Extra-articular tenodesis will be included * Additional meniscus debridement and repair will be included Procedure-specific exclusion criteria * Revision ACL surgery * Moderate to Severe arthritis - Kellgren-Lawerence (KL) Grade \> 3 * Patients with meniscus root repair * Non-weight-bearing status exceeding 1 week postoperatively Total knee arthroplasty (TKA) Procedure specific inclusion criteria * Patients undergoing primary TKA * Preoperative total knee range of motion of at least 100 degrees (combined flexion and extension) * Prior extensor mechanism tendon repair, quadriceps or patella tendon. Procedure specific exclusion criteria * Revision surgery * Hinged implant * Any open procedure involving the knee joint * Symptomatic arthritis in the contralateral knee with planned or expected total knee arthroplasty within 6 months * Inflammatory Arthritis Total hip arthroplasty (THA) Procedure Specific Inclusion Criteria * Patients undergoing primary THA Procedure Specific Exclusion Criteria * Revision Surgery * Any open procedure involving the hip joint * Bilateral THA procedures * Inflammatory Arthritis Hip arthroscopy (HA) for femoroacetabular impingement syndrome (FAIS) Procedure Specific Inclusion Criteria · Patients undergoing HA for FAIS Procedure Specific Exclusion Criteria * Revision Surgery * Diagnosis of hip dysplasia
Contact & Investigator
Jorge Chahla, MD, PhD
PRINCIPAL INVESTIGATOR
Rush University Medical Center
Frequently Asked Questions
Who can join the NCT07020312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anterior Cruciate Ligament Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07020312 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07020312 currently recruiting?
Yes, NCT07020312 is actively recruiting participants. Contact the research team at Brian.forsythe@rushortho.com for enrollment information.
Where is the NCT07020312 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07020312 clinical trial?
NCT07020312 is sponsored by Rush University Medical Center. The principal investigator is Jorge Chahla, MD, PhD at Rush University Medical Center. The trial plans to enroll 240 participants.