Effects of tDCS on Motor Cortex During ACL Recovery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
• Intervention / Treatment: Device: NIBS; Procedure: Rehabilitation; Behavioral: Sham Comparator

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juan Vicente Mampel, PhD; Phone Number: 6437 +34963637412; Email: juan.vicente@ucv.es
• Study Contact Backup: Name: OTRI OTRI; Email: otri@ucv.es

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46001
      • Recruiting
      • Catholic Univerity of Valencia
      • Contact: Juan V-M Vicente Mampel, PhD; Phone Number: +34 674177877; Email: juan.vicente@ucv.es
      • Contact: Josep Lopez Soler, PhD Student; Phone Number: +34 655174010; Email: josep.soler@ucv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIBS + rehabilitation; 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.	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 points and the cathode will be placed at the contralateral supraorbital area Fp1 or Fp2.; 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
Sham Comparator: ShamNIBS + RHB; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography (EMGs)	The The Surface EMG amplitudes of the quadriceps and hamstring muscles. The main device, Musclelab, is equipped with a Musclelab force sensor and wireless surface elec-tromyography (EMGs). Electrode placement will follow the Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscle (SENIAM) protocol from the European Concerted Action in the Biomedical Health and Research Program (BIOMED II). The instructions provided to the patients will be to perform the movement with the max-imum possible contraction, and as rapidly as possible, to achieve the highest peak of force. The patient will carry out 3 familiarization repetitions at a submaximal inten-sity at the beginning of each repetition, and it will begin with the non-surgical ex-tremity, followed by the tests on the surgical extremity. Three effective MVIC attempts will be conducted, each lasting 5 seconds, with a 30-second rest interval between each repetition .	At baseline, 90days post-surgery, 180days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Cruciate Ligament - Quality of Life Questionnaire (ACL - QOL)	This scale is of a continuous quantitative nature. It serves as a Patient-Reported Outcome Measure to assess the impact on the lives of patients with ACL, both pre- and post-treatment, regardless of whether the treatment is surgical or non-surgical. The questionnaire comprises 32 items, categorized into 5 domains: symptoms and physical prob-lems (5 items), work-related problems (4 items), sports participation/competition (12 items), lifestyle (6 items), and social and emotional aspects (5 items). Each domain is allocated a proportional score based on the number of items it contains and is evaluated using a 100-millimeter visual analog scale (VAS). A higher score indicates a better quali-ty of life for the patient. This scale was validated in Spanish, demonstrating a Cronbach's alpha of 0.81 and 0.94 and an intraclass correlation coefficient (ICC) that exhibited good consistency, ranging from 0.88 to 0.96	At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
Lysholm Scale	Its purpose is to evaluate knee functionality in various types of ligament injuries, with the objective of monitoring the progression following an intervention and/or assessing knee deterioration in specific pathologies. The scale comprises eight items (limping, use of support for ambulation, instability, pain, locking, swelling, ability to ascend stairs, and ability to squat). It is evaluated on a scale of 0 - 100, with 100-95 being classified as excellent, 94-84 as good, 83-65 as fair, and less than 65 as poor. Furthermore, each item and the overall score are analysed independently. This scale demonstrates a Cronbach's alpha of 0.737 and an intraclass correlation coefficient of 0.844.	At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
Functional Jump Test	Functional Jump Test have been commonly used for the evaluation of patients after ACLR, especially to assess the Limb Symmetry Index (LSI). Consist in 8 jump tests: Single Hop for Distance (SHD), 6m Timed Hop (6MTH), Triple Hop for Distance (THD), Triple Crossover Hop for Distance (TCHD), Single Medial Hop for Distance (MHD), Single Lateral Hop for Distance (LHD), Single Limb Countermovement Jump for Height (SLCMJ), and Timed Speedy Hop Test (TSHT)	60days post-surgery, 90days post-surgery and 180days post-surgery
Tampa Scale of Kinesiophobia	Tampa Scale of Kinesiophobia is a self-administered questionnaire composed of different questions with a 4-point Likert scale ranging from "strongly disagree" to "strongly agree.".	At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
Pain Catastrophizing Scale	Pain Catastrophizing Scale (PCS) is a self-administered questionnaire (13 items on a Likert-type scale from 0 to 4), will be used in this study to assess the level of catastrophizing in the presence of pain.	At baseline, 30days post-surgery, 60days post-surgery, 90days post-surgery and 180days post-surgery
EGGTMS	Brain Sight ® software to register the hotspot or point of greatest cortical activity following TMS stimulation. The hotspot helps establish the stimulation point to detect the motor threshold of activity using TMS.	At baseline, 90days post-surgery, 180days post-surgery

Collaborators and Investigators

• Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2025
• Primary Completion (Estimated): December 27, 2027
• Study Completion (Estimated): December 27, 2027

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: tDCS; exercise; Anterior Cruciate Ligament; motor control
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: UCV/2023-2024/053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data presented in this study are available on request from the corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No