Brain Stimulation for ACL Reconstruction Rehabilitation

Overseen By Ryan Zarzycki, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Arcadia University

Disqualifiers: Multiple ligament reconstruction, osteochondral procedures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 sessions

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women recover better from ACL surgery by using brain stimulation (transcranial direct current stimulation, or tDCS) to strengthen thigh muscles. Researchers seek to determine if boosting brain signals can enhance muscle strength, speed, and steadiness during rehabilitation exercises. Participants will be divided into two groups: one receiving real brain stimulation and the other a placebo. Ideal participants are women who had ACL surgery 2 to 6 months ago and have no history of severe migraines or seizures. If successful, this method could ease daily activities and facilitate a return to sports after surgery. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this brain stimulation method is safe for ACL rehabilitation?

Research shows that transcranial direct current stimulation (tDCS) is a safe and practical treatment for individuals recovering from ACL (anterior cruciate ligament) surgery. Studies have not found any immediate negative effects from a single session of this brain stimulation, indicating it is well-tolerated. For those considering joining a trial using tDCS, existing research supports its safety for ACL surgery recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial direct current stimulation (tDCS) for ACL reconstruction rehabilitation because it offers a unique non-invasive approach to enhance recovery. Unlike standard physical therapies that focus solely on physical exercises, tDCS targets the brain's motor cortex to potentially boost muscle control and recovery. This technique involves applying a mild electrical current to the scalp, which may accelerate rehabilitation by enhancing neural plasticity and improving motor function. By tapping into the brain’s ability to adapt and reorganize, tDCS could offer a promising complement to traditional rehabilitation methods, potentially speeding up the recovery process for patients.

What evidence suggests that this brain stimulation method is effective for ACL rehabilitation?

This trial will compare the effects of active anodal transcranial direct current stimulation (tDCS) with sham tDCS for rehabilitation after ACL surgery. Research has shown that real anodal-tDCS can improve muscle control, particularly in the thigh muscles, which often weaken after surgery. This treatment enhances the brain's signals to the muscles, increasing their strength and stability. Consequently, individuals may recover faster and more effectively when using active tDCS alongside regular rehab exercises. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for women aged 18-35 who have undergone ACL reconstruction surgery and are experiencing weak thigh muscles. Participants must be within a certain time frame post-surgery to qualify.

Inclusion Criteria

I am a woman who had ACL surgery 2-6 months ago.

Exclusion Criteria

I have had surgery for bone and cartilage issues.

I have had surgery on my legs before.

History of concussion within the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six sessions of active or sham anodal tDCS while performing quadriceps exercises

6 sessions

6 visits (in-person)

Follow-up

Participants are monitored for changes in quadriceps muscle performance and corticospinal excitability

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests the effectiveness of brain stimulation (tDCS) in improving thigh muscle function after ACL surgery. Women will be randomly assigned to receive either real tDCS or sham treatment during strengthening exercises over six sessions.

How Is the Trial Designed?

Group I: Active tDCS Active Control 1 Intervention

This group will receive 20 minutes of active anodal tDCS

Group II: Sham tDCS Placebo Group 1 Intervention

This group will receive sham anodal tDCS. The tDCS unit will be active for the first 30 seconds and the last 30 seconds only.

Who Is Running the Clinical Trial?

Arcadia University

Lead Sponsor

Trials

8

Recruited

1,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. bmjopensem.bmj.com bmjopensem.bmj.com/content/10/4/e002080

Anodal transcranial direct current stimulation (tDCS) ... This study provided proof of the efficacy of anodal-tDCS post ACLR in reducing maladaptive quadriceps inhibition and facilitation.

2. jsams.org jsams.org/article/S1440-2440(24)00388-8/fulltext

The efficacy of transcranial direct current stimulation (tDCS) ... Our data shows that REAL anodal-tDCS significantly improves quadriceps facilitation and inhibition post-ACLR, which is a known driver of arthrogenic muscle ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12571851/

Enhancing functional recovery after ACL injury. A protocol for ... We hypothesize that combining standard rehabilitation with transcranial direct current stimulation (tDCS) may accelerate recovery, improve ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07128602

Determining the Effects of Non-invasive Brain Stimulation ... The investigators will study 42 women, aged 18-35, who had ACL surgery. They'll be split into two groups: one receiving real brain stimulation and another ...

5. brieflands.com brieflands.com/journals/mejrh/articles/130364

The Effects of Transcranial Direct Current Stimulation ... Recently, using transcranial direct current stimulation (tDCS) or biofeedback has been recommended for athletes with ACL rupture. Objectives: This study aimed ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39981427/

Determining the safety, feasibility, and effects of anodal ... Conclusions: TDCS is safe and feasible for participants recovering from ACLR. There were no acute effects of a single session of a-tDCS on CSE ...

7. aoj.amegroups.org aoj.amegroups.org/article/view/9062/html

Determining the safety, feasibility, and effects of anodal ... Anodal transcranial direct current stimulation (a-tDCS) is a safe and feasible intervention for individuals after anterior cruciate ligament reconstruction ( ...

8. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2025.1627228/full

Enhancing functional recovery after ACL injury. A protocol ... The NIBS intervention uses tDCS to deliver low-intensity direct current to modulate cortical excitability. Data collection spans April 2025 to December 2027 ...