Effects of tDCS on Motor Cortex During ACL Recovery

Official title

Effects of Transcranial Direct Current Stimulation Over Motor Cortex During Recovery of ACL Patients

Overview

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.

Detailed 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.

Interventions

• Device NIBS
  A total of 16 sessions will be scheduled, distributed over 8 weeks (2 sessions/week). The continuous current intensity will be set at 2 mA, for 20 minutes. Two electrodes, anode (red) and cathode (black), will be used along with two sponge pads with conductive gel, all combined into a helmet for each patient. The electrodes will be placed according to the international 10-20 system in tDCS. The stimulated area will be the primary motor cortex (M1), so the anode will be placed at the C3 or C4 poi
• Procedure Rehabilitation
  This protocol will consist of 72 sessions, distributed as 3 sessions per week over a period of 24 weeks. Strength will be the prioritized method of work and will be present in all phases. Additionally, periodic measurements will be included to ensure that the patient is making adequate progress and meets the necessary progression criteria to advance to the next phase
• Behavioral Sham Comparator
  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

Primary outcome measures

• Electromyography (EMGs) [Time frame: At baseline, 90days post-surgery, 180days post-surgery]

Secondary outcome measures (6)

• Anterior Cruciate Ligament - Quality of Life Questionnaire (ACL - QOL) [Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery]
• Lysholm Scale [Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery]
• Functional Jump Test [Time frame: 60days post-surgery, 90days post-surgery and 180days post-surgery]
• Tampa Scale of Kinesiophobia [Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery]
• Pain Catastrophizing Scale [Time frame: At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery]
• EGGTMS [Time frame: At baseline, 90days post-surgery, 180days post-surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Catholic Univerity of Valencia — Valencia

Identifiers

NCT: NCT06818201 · UCV/2023-2024/053

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗