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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504344
• Other study ID #: NC NM4R Pilot Project Program
• Status: Completed
• Phase: Phase 1
• Start date: September 15, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Arcadia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Ryan Zarzycki	Glenside	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Arcadia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	isometric quadriceps torque	Nm	3-6 months after ACL Reconstruction
Primary	quadriceps rate of torque development	Nm/s	3-6 months after ACL Reconstruction
Primary	Corticospinal excitability - active motor threshold	percent maximal stimulator output	3-6 months after ACL Reconstruction
Primary	Corticospinal excitability - slope of the stimulus response curve	motor evoked potential/percent active motor threshold	3-6 months after ACL Reconstruction