Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction
Primary Purpose
Anterior Cruciate Ligament Reconstruction, Quadriceps Muscle Weakness, Transcranial Direct Current Stimulation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Reconstruction focused on measuring corticospinal excitability
Eligibility Criteria
Inclusion Criteria:
-Underwent primary ACL reconstruction within 3-6 months
Exclusion Criteria include:
- 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
Sites / Locations
- Ryan Zarzycki
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
Active tDCS
Sham tDCS
Outcomes
Primary Outcome Measures
isometric quadriceps torque
Nm
quadriceps rate of torque development
Nm/s
Corticospinal excitability - active motor threshold
percent maximal stimulator output
Corticospinal excitability - slope of the stimulus response curve
motor evoked potential/percent active motor threshold
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04504344
Brief Title
Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction
Official Title
Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arcadia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Reconstruction, Quadriceps Muscle Weakness, Transcranial Direct Current Stimulation
Keywords
corticospinal excitability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Active tDCS
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS
Intervention Type
Device
Intervention Name(s)
Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)
Intervention Description
We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.
Primary Outcome Measure Information:
Title
isometric quadriceps torque
Description
Nm
Time Frame
3-6 months after ACL Reconstruction
Title
quadriceps rate of torque development
Description
Nm/s
Time Frame
3-6 months after ACL Reconstruction
Title
Corticospinal excitability - active motor threshold
Description
percent maximal stimulator output
Time Frame
3-6 months after ACL Reconstruction
Title
Corticospinal excitability - slope of the stimulus response curve
Description
motor evoked potential/percent active motor threshold
Time Frame
3-6 months after ACL Reconstruction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Underwent primary ACL reconstruction within 3-6 months
Exclusion Criteria include:
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
Facility Information:
Facility Name
Ryan Zarzycki
City
Glenside
State/Province
Pennsylvania
ZIP/Postal Code
19038
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-invasive Brain Stimulation to Improve Quadriceps Muscle Function After Anterior Cruciate Ligament Reconstruction
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