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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
Arcadia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Reconstruction focused on measuring corticospinal excitability

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 20, 2020
Last Updated
August 7, 2023
Sponsor
Arcadia University
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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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