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Determining the Effects of Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After ACL Reconstruction

Determining the Effects of Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After ACL Reconstruction.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07128602
Enrollment
42
Registered
2025-08-19
Start date
2025-06-06
Completion date
2028-03-01
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation, Quadriceps Muscle Function

Keywords

acl, acl reconstruction, corticospinal excitability, non-invasive brain stimulation

Brief summary

After knee surgery for a torn ACL, many women struggle with weak thigh muscles for years, partly due to reduced brain signals to these muscles. Our research tests a new approach to improve recovery by using low-level brain stimulation to boost these signals. 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 getting a placebo, both during thigh-strengthening exercises. Over six sessions, the investigators measure thigh muscle strength, speed, and steadiness, plus two brain signal measures, using special equipment. The investigators will also check if stronger brain signals lead to better muscle performance, especially in women. Our goal is to show that this new method strengthens thigh muscles better than standard rehab, helping women recover better after surgery. If successful, this could improve physical therapy for women recovering from ACL surgery, making daily activities and return to sport easier.

Detailed description

Quadricep muscle impairments persist for years after anterior cruciate ligament reconstruction (ACLR). Recent evidence suggests that lower neural drive, (i.e., lower corticospinal excitably (CSE)), is associated with pronounced quadriceps muscle performance deficits, which are more severe in females recovering from ACLR than in males. Current postoperative rehabilitation protocols do not target lower neural drive, which can be achieved through non-invasive brain stimulation. Thus, the long-term goal of this research is to improve the effectiveness of ACLR rehabilitation. The objective of this project is to determine if neural drive is the critical missing link in ACLR rehabilitation. To meet this objective, the investigators will administer anodal transcranial direct current stimulation (tDCS), a type of non-invasive brain stimulation known to increase CSE. The investigators will then assess whether it improves three measures of quadriceps muscle performance (in Aim 1) and two measures of CSE (in Aim 2). In Aim 3, the investigators will determine the relationship between observed changes in quadriceps muscle performance and CSE in female participants recovering from ACLR. These aims will be achieved using a randomized, triple-blinded clinical trial with 42 female individuals after ACLR between the ages of 18 and 35 years. All participants will receive six sessions of active or sham anodal tDCS while they perform isolated quadriceps exercises on an isokinetic dynamometer. The two measures of CSE (i.e. active motor threshold and the slope of transcranial magnetic stimulation (TMS) induced recruitment curves) will be determined using surface electromyography on the vastus medialis and TMS. Three measures of quadriceps performance (i.e. peak torque normalized to body weight, rate of torque development (RTD) from 0-100ms and 100-200ms, and torque steadiness) will be determined following standard isometric muscle testing on an isokinetic dynamometer with the hips flexed to 90° and the knees flexed to 60°.

Interventions

DEVICEactive transcranial direct current stimulation (tDCS)

20 minutes of anodal tDCS over the primary motor cortex contralateral to the participants surgical limb during a quadriceps torque matching task

DEVICEsham transcranial direct current stimulation (tDCS)

Participants receive sham tDCS in which the device only delivers current during the first and last 30 seconds while participants perform a quadriceps torque matching task

Sponsors

Arcadia University
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Triple-blinded randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

\- females 2-6 months after ACL reconstruction

Exclusion criteria

* multiple ligament reconstruction * osteochondral procedures * any previous lower extremity surgery * previous ACL injury * Metal or implants in the head or neck * history of neurological disease * seizures * severe migraines * concussion within the last 6 months

Design outcomes

Primary

MeasureTime frameDescription
Peak quadriceps muscle torquePre and post interventionPeak torque during a 5 second maximal voluntary isometric contraction
Corticospinal excitability (Slope)Pre and post interventionSlope of a TMS induced stimulus-response curve

Secondary

MeasureTime frameDescription
Rate of Torque Development (RTD)Pre and post interventionRTD of a maximal voluntary isometric contraction from onset to 100ms (RTD100) and from 100 to 200ms (RTD200) will be used.
Corticospinal excitability (Active Motor Threshold)Pre and post interventionThe lowest stimulator intensity needed to produce consistent MEPs \>/= 100 microvolts while the participant maintains an isometric contraction at 5% of their MVIC

Countries

United States

Contacts

CONTACTRyan Zarzycki, PhD
zarzyckir@arcadia.edu215-572-2852

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026