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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.

The efficacy of Transcranial direct current stimulation during rehabilitation following Anterior Cruciate Ligament (ACL) reconstruction on functional outcomes and return to play timelines. A double-blind randomised controlled trial (The TACL study)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000183785
Acronym
TACL
Enrollment
26
Registered
2022-02-02
Start date
2022-10-03
Completion date
2024-02-12
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with musculoskeletal pain and injury exhibit higher than expected cortical inhibition, which means that the brain actively inhibits the recruitment of motor units and hence impairs motor function. Specifically, following ACLR and a rehabilitation program targeting lower limb strength, decreased quadriceps strength has been associated with abnormal cortical inhibition, with higher than expected corticospinal inhibition present even at the stage athletes return to running. One intervention proposed to assist in the reduction of cortical inhibition and improve motor drive is transcranial direct current stimulation (tDCS). tDCS can be applied to the motor cortex using a direct current via electrodes placed on the head when performing exercise. tDCS has been shown to improve muscle strength and assist in motor learning making it feasible that applying tDCS to a cohort of ACLR patients may improve functional outcomes. Specifically, anodal tDCS to the primary motor cortex has been shown to reduce intracortical inhibition, potentially addressing the identified deficits following ACLR. Objectives 1. Determine if the addition of tDCS is superior to sham tDCS for improvements in knee muscle strength and motor control following ACL-R in the short and long-term. 2. Determine if the addition of tDCS results in a reduced timeline to pass a return to play testing battery compared to sham tDCS.

Interventions

Exercise rehabilitation Participants will follow the Melbourne ACL rehabilitation guide that details the rehabilitation requirements for each phase. The rehabilitation protocol to be followed will be provided by one of five different physiotherapists working at SportsMed Subiaco, but each participant will be followed through via the same physiotherapist, and participants will attend for supervised rehabilitation and program upgrades at the following timepoints (some flexibility based on partici

Exercise rehabilitation Participants will follow the Melbourne ACL rehabilitation guide that details the rehabilitation requirements for each phase. The rehabilitation protocol to be followed will be provided by one of five different physiotherapists working at SportsMed Subiaco, but each participant will be followed through via the same physiotherapist, and participants will attend for supervised rehabilitation and program upgrades at the following timepoints (some flexibility based on participants schedule): 2 weeks post-op, 4 weeks post-op, 6 weeks post-op, 8 weeks post-op, 12 weeks post-op and then monthly until they achieve the final exit criteria to return to play with assessments performed by an independent investigator not completing participant rehabilitation. Rehabilitation duration will vary from between 15 minutes to 60 minutes depending on the stage of the program and the physical demands of this individual. Participants will record exercise adherence using the Physitrack software. Exercises will initially start with body weight exercises (e.g., bridging or sit to stand), progress into more complex movements (e.g., deadlifts) and machine resistance training (e.g., leg press) before incorporating running, agility and sport specific exercises. Participants will be provided complimentary access to the gym at SportsMed Subiaco to complete their rehabilitation. Alternatively, if they have an existing gym membership we will provide the supervised consultation to set/ upgrade the program at SportsMed Subiaco and allow them to use their own gym membership if more convenient. Modifications to exercise rehabilitation can be incorporated into the initial rehabilitation program as required, especially within Phase One of the Melbourne ACL rehabilitation guide 2.0. Transcranial direct current stimulation (tDCS) All participants will have a screening session with a medical doctor (CW) to assess relevant medical history, medication use and suitability for tDCS. Participants will then be instructed in how to use the tDCS device. Transcranial direct current stimulation is a safe, non-invasive form of brain stimulation which passes a weak direct electrical current (typically <2 mA, c.f., 800-900mA for ECT) between an anodal and cathodal electrode placed on the scalp and has an excellent safety profile. Generally, cortical excitability is increased with the application of anodal tDCS (anode applied to the target cortical region). There is evidence that tDCS application to the primary motor cortex may promote an increase in muscular maximal voluntary contraction and possibly muscular endurance, improve balance performance, gait retraining, multi-task performance and motor learning of sport specific skills and tasks. The potential benefits of tDCS application align with ACL rehabilitation goals, namely preventing the loss of/regaining muscular strength, regaining and improving neuromuscular control and the re-introduction of sport specific movements and tasks. Single session and repeated tDCS are widely used in research involving both healthy participants and those with pain disorders, stroke, neurocognitive disorders and neuropsychiatric disorders. Both single session and repeated tDCS have been shown to be safe when applied with stimulation parameters in line with published guidelines for the safe use of tDCS. Adverse effects associated with tDCS are either rare or mild (commonly reported sensations include mild tingling or itching of the scalp). Given the location of the quadriceps/knee representation in the primary motor cortex, participants will have an anodal electrode applied to the vertex of the scalp, overlying the bilateral lower limb primary motor cortex (M1) representation. This area can be located using the International 10/20 system (an internationally recognised method to describe scalp electrode locations). The cathode will be applied to the contralateral shoulder (i.e. opposite shoulder to the injured lower limb). Participants will receive tDCS at 2 milliamps (mA) for 20 minutes, during which time rehabilitation exercises will commence (tDCS is considered to be online, referring to rehabilitation occurring while stimulation is being applied, however rehabilitation exercises will continue after the completion of 20 minutes of tDCS). The tDCS device will be fitted by the onsite physiotherapist. For maximal benefit tDCS application during rehabilitation will be encouraged up to three times per week during the intervention period at a similar time of day.

Sponsors

Edith Cowan University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026