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

NCT07128602 | Recruiting Phase 1 FDA Device

• 2 other identifiers: Arcadia University1R15HD118518-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation; Quadriceps Muscle Function

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Peak quadriceps muscle torque

  Peak torque during a 5 second maximal voluntary isometric contraction

  Pre and post intervention

• Corticospinal excitability (Slope)

  Slope of a TMS induced stimulus-response curve

  Pre and post intervention

Secondary Outcomes (2)

• Rate of Torque Development (RTD)

  Pre and post intervention

• Corticospinal excitability (Active Motor Threshold)

  Pre and post intervention

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

This group will receive 20 minutes of active anodal tDCS

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.

Device: sham transcranial direct current stimulation (tDCS)

Interventions

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

Active tDCS

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

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- females 2-6 months after ACL reconstruction

You may not qualify if:

• 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

Sponsors & Collaborators

• Arcadia University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Ryan Zarzycki

Glenside, Pennsylvania, 19038, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 37938095 BACKGROUND

• Zarzycki 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.

  PMID: 39981427 BACKGROUND

Central Study Contacts

Ryan Zarzycki, PhD

CONTACT

215-572-2852; zarzyckir@arcadia.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Triple-blinded randomized controlled trial

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 19, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 4, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available no later than time of an associated publication or end of the performance period, whichever comes first. Data will be available indefinitely, based on the repository policy.
• Access Criteria: Anyone with access to DASH will be able to examine the data including researchers interested in study replication.

Locations

US (1)