Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction

NCT ID: NCT04504344

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2023-07-31

Brief Summary

Quadriceps muscle dysfunction persists for years after anterior cruciate ligament reconstruction (ACLR) and is related to poor self-reported outcomes, altered movement patterns and joint loading associated with post-traumatic knee osteoarthritis (OA), and higher risk of reinjury. Emerging evidence indicates that central drive (pathway from the brain to the muscle of interest, i.e corticospinal excitability) to the quadriceps muscle is reduced as early as 2 weeks after surgery and can persist for years after ACLR, meaning that current rehabilitation strategies may not be addressing potential maladaptive changes in central drive. Anodal tDCS is a neurostimulation technology that increases brain excitability (i.e. central drive) and has the potential to address alterations in central drive and quadriceps muscle performance. The purpose of this study is twofold: 1) to determine the effects of anodal tDCS on central drive and quadriceps muscle performance in patients after ACLR, and 2) determine the relationship between central drive and quadriceps muscle performance in patients after ACLR. Central drive will be defined by two measures: 1) active motor thresholds, and 2) slope of a stimulus response curve. Quadriceps muscle performance will be defined by two measures: 1) isometric quadriceps strength, and 2) rate of torque development (RTD). For purpose 1 the investigators hypothesize that measures of central drive and quadriceps muscle performance will increase with administration of active anodal tDCS compared to no change with sham tDCS. For purpose 2 the investigators hypothesize that both measures of central drive will be associated with both measures of quadriceps performance, with a stronger association between central drive and RTD. Following a cross-over design patients 3-6 months from ACLR will receive active and sham anodal tDCS at different sessions separated by 7-10 days while they ride a stationary bike for 20 minutes. Bike position and intensity will be standardized for all patients to maximize quadriceps activity. Findings from this study will expand our basic science knowledge on how tDCS effects different aspects of corticospinal excitability and quadriceps strength, and lead to subsequent studies to determine the effects of multiple sessions of tDCS on corticospinal excitability and quadriceps muscle performance in patients recovering from ACLR.

Conditions

Anterior Cruciate Ligament Reconstruction; Quadriceps Muscle Weakness; Transcranial Direct Current Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active tDCS

Active tDCS

Group Type: EXPERIMENTAL

Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)

Intervention Type: DEVICE

We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.

Sham tDCS

Sham tDCS

Group Type: SHAM_COMPARATOR

Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)

Intervention Type: DEVICE

We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.

Interventions

Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)

We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

-Underwent primary ACL reconstruction within 3-6 months

Exclusion Criteria

• multiple ligament reconstruction
• osteo-chondral procedures
• any previous lower extremity surgery
• previous ACL injury
• Metal or implants in the head or neck
• history of neurological disease, seizures, severe migraines, and concussion within the last 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcadia University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Zarzycki

Assistant Professor Department of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ryan Zarzycki

Glenside, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39981427 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37938095 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NC NM4R Pilot Project Program

Identifier Type: -

Identifier Source: org_study_id