Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedAugust 9, 2023
August 1, 2023
2.9 years
July 20, 2020
August 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
isometric quadriceps torque
Nm
3-6 months after ACL Reconstruction
quadriceps rate of torque development
Nm/s
3-6 months after ACL Reconstruction
Corticospinal excitability - active motor threshold
percent maximal stimulator output
3-6 months after ACL Reconstruction
Corticospinal excitability - slope of the stimulus response curve
motor evoked potential/percent active motor threshold
3-6 months after ACL Reconstruction
Study Arms (2)
Active tDCS
EXPERIMENTALActive tDCS
Sham tDCS
SHAM COMPARATORSham tDCS
Interventions
We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.
Eligibility Criteria
You may qualify if:
- Underwent primary ACL reconstruction within 3-6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ryan Zarzycki
Glenside, Pennsylvania, 19038, United States
Related Publications (2)
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: 39981427DERIVEDLeung 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: 37938095DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Department of Physical Therapy
Study Record Dates
First Submitted
July 20, 2020
First Posted
August 7, 2020
Study Start
September 15, 2020
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
August 9, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share