Does the inclusion of transcranial direct current stimulation of the brains motor cortex improve outcomes when combined with rehabilitation following Anterior Cruciate Ligament (ACL) reconstruction.

Not Applicable

Active, not recruiting

• Conditions: Anterior Cruciate Ligament Rupture; Musculoskeletal - Other muscular and skeletal disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12622000183785
• Lead Sponsor: Edith Cowan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Participants who have suffered a non-contact, primary isolated ACL rupture during type one or two physical activity (using the IKDC classification system) without concurrent knee injury severe enough to require surgical intervention if the ACL was intact (e.g. concurrent PCL rupture or bucket handle meniscal tear would be excluded) will be eligible to participate within this study. Participants will have an ACLR using a hamstring graft. ACLR will occur within six weeks of ACL injury. Specifically:
•Over 18 years of age
•Acute non-contact, primary ACL rupture diagnosed clinically by an orthopaedic surgeon, confirmed with magnetic resonance imaging pre-surgery and confirmation of ACL rupture during surgery.
•Able to proceed to ACLR within 4 weeks of baseline neurophysiological testing
•Able to attend scheduled follow-up sessions
•Able to give consent

Exclusion Criteria

•Concurrent knee injuries severe enough to require surgery (e.g. concurrent PCL rupture or bucket handle meniscal tear)
•Previous lower limb surgery
•Concurrent musculoskeletal injury to the lower limb
•Pregnancy
Conditions that may impact the safety of tDCS:18
•Previous tDCS leading to adverse effects
•Skin lesions or sensitive scalp
•Neurological conditions/illness, including epilepsy/convulsion/seizure
•Previous or current implants in their body that may be triggered or heated by an electrical current (e.g. pacemaker, intracranial shunts, artificial cochlea, etc)
•Any mental implanted in their head (e.g. surgical clips, staples, shrapnel)
•Frequent or intense headaches
•Previous brain trauma or neurosurgical intervention
•Serious medical complications (e.g. advanced pulmonary, cardiac, liver or kidney disease)
•Pharmacological treatment for depression
•Neuropsychotropic drugs (e.g. antiepileptics, neuroleptics, benzodiazepines, antidepressants) or drugs with an effect on neuroplasticity (dopamine, fluoxetine or D-amphetamine, sodium or calcium channel blockers, NMDA receptor antagonists)
•History of significant alcohol or substance abuse, as identified through screening questionnaire
Conditions that may impact the safety of transcranial magnetic stimulation (TMS) use:19
•History of epilepsy (treated or untreated)
•Vascular, traumatic, tumoural, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
•Administration of drugs that potentially lower seizure threshold, without concomitant administration of anticonvulsant drugs which potentially protect against seizure occurrence
•Sleep deprivation* the night before, alcoholism , as identified through screening questionnaire
•Implanted brain electrodes (cortical or deep-brain electrodes)
•Severe or recent heart disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Motor cortex excitability measured using Transcranial Magnetic Stimulation (TMS). <br><br>TMS will be assessed at both Edith Cowan University and Murdoch University. TMS will assess Motor cortex excitability: delivery of non-invasive transcranial magnetic stimulation (TMS) to the brain to elicit motor response in quadriceps muscle to assess various aspects of motor cortex excitability (motor evoked potential (MEP), resting motor threshold (RMT), active motor threshold (AMT), MEP120 and short-interval intracortical inhibition (SICI)) that all indicate cortex excitability. [ Pre-op and then post-op at weeks 2, 8, 16, 26 and 52. ]