Anterior Cruciate Ligament Reconstruction RehabilitationNCT07128602
Determining the Effects of Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After ACL Reconstruction
A study testing active transcranial direct current stimulation (tDCS) in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Quadriceps Muscle Function, run by Arcadia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Quadriceps Muscle Function
- What is being tested?
- active transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- females 2-6 months after ACL reconstruction
Who cannot join
- 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
Show all 9Show fewer
- seizures
- severe migraines
- concussion within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ryan Zarzycki
Glenside, Pennsylvania, 19038
Ryan Zarzycki, PT, PhD, 215-572-8527, zarzyckir@arcadia.edu
About this study
Official title: Determining the Effects of Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After ACL Reconstruction.
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.
Read the 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°.
- Being tested
- active transcranial direct current stimulation (tDCS), sham transcranial direct current stimulation (tDCS)
- Keywords
- acl, acl reconstruction, corticospinal excitability, non-invasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active transcranial direct current stimulation (tDCS)Device
20 minutes of anodal tDCS over the primary motor cortex contralateral to the participants surgical limb during a quadriceps torque matching task
sham transcranial direct current stimulation (tDCS)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | This group will receive 20 minutes of active anodal tDCS Receives: Device: active transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | This group will receive sham anodal tDCS. The tDCS unit will be active for the first 30 seconds and the last 30 seconds only. Receives: Device: sham transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak quadriceps muscle torque
Peak torque during a 5 second maximal voluntary isometric contraction
Measured: Pre and post intervention
Corticospinal excitability (Slope)
Slope of a TMS induced stimulus-response curve
Measured: Pre and post intervention
Secondary outcomes (2)
Rate of Torque Development (RTD)
RTD of a maximal voluntary isometric contraction from onset to 100ms (RTD100) and from 100 to 200ms (RTD200) will be used.
Measured: Pre and post intervention
Corticospinal excitability (Active Motor Threshold)
The lowest stimulator intensity needed to produce consistent MEPs >/= 100 microvolts while the participant maintains an isometric contraction at 5% of their MVIC
Measured: Pre and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start6 Jun 2025
- Primary completion31 Jan 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple-blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcadia University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Ryan Zarzycki, Arcadia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128602
- Sponsor's protocol ID
- Arcadia University
- Other IDs
- 1R15HD118518-01
- Status last verified
- May 2026
- First submitted
- 14 Aug 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study team will submit all primary and secondary outcome data to DASH at the completion of all data collections and prior to any publications. Demographic data including age, sex, and activity level will also be uploaded to DASH.
Publications
Leung A, Kantak S, Hammoud S, Abraham R, Zarzycki R. Sex differences in corticospinal excitability and quadriceps performance after anterior cruciate ligament reconstruction. J Orthop Res. 2024 Apr;42(4):769-776. doi: 10.1002/jor.25725. Epub 2023 Nov 27.
PubMed 37938095Zarzycki R, Leung A, Abraham R, Hammoud S, Perrone M, Kantak S. Determining the safety, feasibility, and effects of anodal transcranial direct current stimulation on corticospinal excitability and quadriceps performance after anterior cruciate ligament reconstruction: a randomized crossover design. Ann Jt. 2025 Jan 21;10:3. doi: 10.21037/aoj-24-15. eCollection 2025.
PubMed 39981427
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effects of Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After ACL Reconstruction.
- ClinicalTrials.gov ID
- NCT07128602
- Acronym / sponsor ID
- Arcadia University
- Keywords
- acl, acl reconstruction, corticospinal excitability, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Arcadia UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Jun 2025 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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°.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Triple-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: active transcranial direct current stimulation (tDCS)This group will receive 20 minutes of active anodal tDCS |
| Sham tDCS | Sham comparator | Device: sham transcranial direct current stimulation (tDCS)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 may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- females 2-6 months after ACL reconstruction
Key exclusion criteria (9 listed)
- multiple ligament reconstruction
- osteochondral procedures
- any previous lower extremity surgery
- previous ACL injury
- Metal or implants in the head or neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active 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 | Device | Active tDCS |
| sham 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 | Device | Sham tDCS |
Primary outcome
Peak quadriceps muscle torque
Time frame: Pre and post intervention
Peak torque during a 5 second maximal voluntary isometric contraction
Corticospinal excitability (Slope)
Time frame: Pre and post intervention
Slope of a TMS induced stimulus-response curve
2 secondary outcomes
Rate of Torque Development (RTD)
Time frame: Pre and post intervention
Corticospinal excitability (Active Motor Threshold)
Time frame: Pre and post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 37938095Leung A, Kantak S, Hammoud S, Abraham R, Zarzycki R. Sex differences in corticospinal excitability and quadriceps performance after anterior cruciate ligament reconstruction. J Orthop Res. 2024 Apr;42(4):769-776. doi: 10.1002/jor.25725. Epub 2023 Nov 27.
- Background: PubMed 39981427Zarzycki R, Leung A, Abraham R, Hammoud S, Perrone M, Kantak S. Determining the safety, feasibility, and effects of anodal transcranial direct current stimulation on corticospinal excitability and quadriceps performance after anterior cruciate ligament reconstruction: a randomized crossover design. Ann Jt. 2025 Jan 21;10:3. doi: 10.21037/aoj-24-15. eCollection 2025.
- Individual participant dataSharing planned: Yes. The study team will submit all primary and secondary outcome data to DASH at the completion of all data collections and prior to any publications. Demographic data including age, sex, and activity level will also be uploaded to DASH.
Related trials for Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
Recruiting
The Effect of Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
The Effect of Isokinetic Vs Plyometric Training in Post-ACLR Surgery
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Reconstruction Rehabilitation
Recruiting
Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction
Knee Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active transcranial direct current stimulation (tDCS) in people with Anterior Cruciate Ligament Reconstruction Rehabilitation and Quadriceps Muscle Function, run by Arcadia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ryan Zarzycki, PhD (215-572-2852, zarzyckir@arcadia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak quadriceps muscle torque (time frame: Pre and post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07128602, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.