Effects of tDCS on Motor Cortex During ACL Recovery

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Enrolling

Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation

Treatments: Procedure: Rehabilitation; Behavioral: Sham Comparator; Device: NIBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06818201

UCV/2023-2024/053

Details and patient eligibility

About

Anterior Cruciate Ligament (ACL) is a prevalent injury, particularly among young and physically active individuals. The efficacy of transcranial direct current stimulation (tDCS) and exercise-based rehabilitation on neuromuscular control in post-ACL reconstruction patients is evaluated, and these techniques are combined.

Full description

Anterior cruciate ligament (ACL) rupture is a common injury, particularly among young and physically active individuals, with an incidence of 0.4 to 0.8 injuries per 1,000 person-years. While the majority of ruptures occur during sports activities (65-75%), a significant proportion (25-35%) happen in non-sport settings. Rehabilitation is crucial for recovery, but only 65% of patients return to their pre-injury activity level, and only 55% resume competitive activities. Neuromuscular structures such as the hamstrings and hip abductors play a vital role in reducing the risk of re-injury and aiding post-surgical rehabilitation.

Arthrogenic muscle inhibition (AMI) is a common phenomenon following ACL surgery, affecting quadriceps activation and force generation. While spinal mechanisms of AMI have been extensively studied, the influence of supraspinal centers, such as the motor cortex, in modulating AMI is also recognized. Traditional treatments, such as electrostimulation, are largely ineffective, and non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), combined with exercise rehabilitation, are being explored to improve neuromuscular control.

This study aims to evaluate the effects of combined tDCS and exercise-based rehabilitation, comparing it to sham tDCS treatment. Outcomes will include cortical reorganization, corticospinal activation, pain perception, and psychosocial and functional variables. The central hypothesis is that reducing cortical hyperexcitability will enhance neuromuscular control, leading to improved outcomes and a reduced risk of re-injury.

Enrollment: 54 estimated patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis complete ACL tear through clinical evaluation and MRI imaging.
• Patients who have received surgical intervention.
• Aged between 16 and 40 years.
• Tegner activity level of 4 or higher.

Exclusion criteria

• Rupture, such as tendons, cartilage, bones, or ligaments.
• Absence of any pre-existing or current lower limb pathologies, such as open surgeries, knee arthroscopies, or femur/tibia fractures.
• Neuromuscular or metabolic diseases.
• Concussion within the past six months are not eligible.
• Cranial surgery or have intracranial metal clips are ineligible.
• Taking medications that affect neuronal activity.
• Neurological diseases or disorders are not eligible for participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

NIBS + rehabilitation

Experimental group

Description:

The intervention using tDCS will be performed through the Home tDCS device (Ionclinics®). It will be introduced in the first part of the rehabilitation, during activation, because the required exercises will be of lower intensity, complexity, and more compatible with this intervention.

Treatment:

Device: NIBS

Procedure: Rehabilitation

ShamNIBS + RHB

Sham Comparator group

Description:

The device will be configured to produce an ascending ramp lasting 30 seconds, identical to the one used in the experimental group, followed by a descending ramp of another 30 seconds. Thus, the control group will experience a sensation of tingling on the scalp, similar to that felt by the experimental group. This stimulation will have a total duration of 1 minute, which will not be sufficient to induce changes in cortical excitability

Treatment:

Behavioral: Sham Comparator

Procedure: Rehabilitation